Professional Documents
Culture Documents
Pepsico Beverage Sanitation Manual - April 2019 - Version 5
Pepsico Beverage Sanitation Manual - April 2019 - Version 5
Sanitation Manual
12000.9071
APRIL 2019 – VERSION 5
Revisions to this manual
(Current revision in bold type)
Original manual: August 2010 (Version 1)
First revision: June 2012 (Version 2)
Second revision August 2014 (Version 3)
Third revision August 2017 (Version 4)
Fourth revision April 2019 (Version5)
PepsiCo
700 Anderson Hill Road
Purchase, NY 10577
USA
PepsiCo Beverage Sanitation Manual Table of Contents
Table of Contents
Chapter 1: Introduction ........................................................................................................... 1-1
1.0 Overview..................................................................................................................................................... 1-2
1.1 Purpose........................................................................................................................................... 1-2
1.1.1 Scope ................................................................................................................................ 1-2
1.1.2 Audience for This Manual .................................................................................................. 1-3
1.1.3 Approval ............................................................................................................................ 1-3
1.2 PepsiCo Sanitation Requirements .................................................................................................... 1-4
1.3 Background of Beverage Sanitation ................................................................................................. 1-5
1.4 Roles and Responsibilities for Beverage Sanitation .......................................................................... 1-5
1.4.1 Product Development......................................................................................................... 1-5
1.4.2 Facility and Equipment Hygienic Design ............................................................................ 1-6
1.4.3 Operations ........................................................................................................................ 1-6
1.5 Glossary of Terms ........................................................................................................................... 1-7
1.6 References..................................................................................................................................... 1-11
Chapter 2: Beverage Sanitation Program .................................................................................. 2-1
2.0 Beverage Sanitation Program ...................................................................................................................... 2-2
2.1 Scope and Guidelines of Beverage Sanitation Programs ................................................................... 2-2
2.1.1 Product ............................................................................................................................. 2-2
2.1.2 Production and Processing Rooms ..................................................................................... 2-2
2.1.3 Plant and Plant Site ........................................................................................................... 2-3
2.1.4 Plant Employees ................................................................................................................ 2-3
2.1.5 Sanitation Schedules and Procedures ................................................................................ 2-4
2.1.5.1 Housekeeping Schedule ....................................................................................... 2-4
2.1.5.2 Master Sanitation Schedule (MSS) ....................................................................... 2-4
2.1.5.3 Sanitation Standard Operating Procedures (SSOP)............................................... 2-4
2.2 Beverage Sanitation Schedules ........................................................................................................ 2-4
2.2.1 Example of Master Cleaning Schedule (MCS) ..................................................................... 2-7
2.3 Beverage Sanitation Standard Operating Procedures (SSOP) ............................................................ 2-8
2.3.1 Guidelines for Developing SSOPs ....................................................................................... 2-8
2.3.1.1 Development of SSOP .......................................................................................... 2-8
2.3.1.2 Implementation of SSOP ...................................................................................... 2-9
2.3.1.3 Maintenance of SSOP ........................................................................................ 2-10
2.3.1.4 Corrective Actions for SSOP ............................................................................... 2-10
2.3.1.5 Record Keeping for SSOP ................................................................................... 2-10
2.3.1.6 Example of an SSOP .......................................................................................... 2-11
2.3.1.7 SSOP Checklist ................................................................................................. 2-13
Chapter 3: Beverage Microbiology ............................................................................................ 3-1
3.0 Beverage Microbiology ................................................................................................................................ 3-2
3.1 Factors Affecting the Growth of Microorganisms in Food and Beverage Processing ........................... 3-2
3.1.1 Intrinsic Factors ................................................................................................................ 3-3
3.1.1.1 Beverage Design: Water Activity ........................................................................... 3-3
3.1.1.2 Beverage Design: Available Nutrients ................................................................... 3-3
3.1.1.3 Beverage Design: pH ............................................................................................ 3-3
3.1.1.4 Acidity and pH .................................................................................................... 3-4
3.1.2 Process Factors ................................................................................................................. 3-5
3.1.2.1 Beverage Design: Antimicrobial Constituents ....................................................... 3-5
7.2.2.19 S. High-Acid Chilled Distribution non-ESL and ESL - 5-Step CIP – Alkaline
Detergent and Steam or High Temperature Water Sanitize ............................................... 7-31
7.2.2.20 T. Low-Acid Chilled Distribution ESL Bottle - 5-Step CIP – Alkaline
Detergent and Steam or High Temperature Water Sanitize ............................................... 7-32
7.2.2.21 U. High-Acid Chilled Distribution Ultra-Clean Bottle - 5-Step CIP – Alkaline
Detergent and Steam or High Temperature Water Sanitize ............................................... 7-33
7.2.2.22 V. Allergen Cleaning Protocol ............................................................................ 7-34
7.2.2.23 W. Kosherization Sanitizing Protocol ................................................................. 7-35
7.2.2.24 X. Non-Genetically Modified Organism (GMO) Cleaning Protocol ....................... 7-36
Chapter 8: Validation and Verification of Sanitation ................................................................ 8-1
8.0 Validation and Verification of Sanitation ..................................................................................................... 8-2
8.1 Objectives of Validation and Verification .......................................................................................... 8-2
8.2 Basic Requirements for CIP Validation............................................................................................. 8-2
8.2.1 Basic Requirements for Automated Sanitation Equipment for External Sanitation
Validation ........................................................................................................................................ 8-3
8.2.2 Verification: Microbiological ............................................................................................... 8-3
8.3 Verification by ATP Analyses (Adenosine Triphosphate).................................................................... 8-4
8.3.1 ATP Strategies ................................................................................................................... 8-4
8.3.2 ATP Precautions ................................................................................................................ 8-4
8.4 Verification by Thonhauser Persulfate Technologies ......................................................................... 8-5
8.5 Allergen Validation Cleaning Programs ............................................................................................ 8-5
8.5.1 Allergen Cleaning Validation Strategies .............................................................................. 8-5
8.5.2 Allergen Validation Requirements ...................................................................................... 8-6
8.5.3 Beverage Cleaning Strategies ............................................................................................. 8-6
8.5.3.1 Protein-Specific Validation .............................................................................. 8-6
8.5.4 Protein-Specific Test Kit Specifics ...................................................................................... 8-7
8.5.4.1 Sensitivity Validation ...................................................................................... 8-7
8.5.5 Ongoing Allergen Verification ............................................................................................. 8-7
8.5.6 Suggested Areas for Swabbing ........................................................................................... 8-8
8.5.7 Suggested Allergen Test Kits (ELISA) .................................................................................. 8-8
8.5.8 Suggested Allergen Testing Laboratory ............................................................................... 8-8
8.5.9 Suggested Cleaning Agents for Allergens ............................................................................ 8-9
Chapter 9: Environment, Health and Safety ............................................................................. 9-1
9.0 Environment, Health and Safety ................................................................................................................. 9-2
9.1 Key parts of a Sanitation Safety program ......................................................................................... 9-2
9.1.1 Labeling ............................................................................................................................ 9-2
9.1.2 Material Safety Data Sheet (MSDS) .................................................................................... 9-3
9.1.3 Employee Training and Chemical Handling ........................................................................ 9-3
9.1.3.1 Receiving ........................................................................................................ 9-3
9.1.3.2 Storage ........................................................................................................... 9-4
9.1.3.3 Transfer .......................................................................................................... 9-4
9.1.3.4 Dilution .......................................................................................................... 9-4
9.1.3.5 Application ..................................................................................................... 9-5
9.1.4 Functional Storage and Handling Equipment ..................................................................... 9-5
9.1.5 Personal Protective Equipment (PPE) ................................................................................. 9-5
9.1.6 First Aid Training .............................................................................................................. 9-6
9.1.7 Chemical Disposal ............................................................................................................. 9-6
9.1.8 Chemical Spill Response .................................................................................................... 9-6
9.2 References....................................................................................................................................... 9-7
Chapter 10: Approval of Cleaning and Sanitizing Chemicals and Suppliers ............................ 10-1
10.0 Approval of Cleaning and Sanitizing Chemicals and Suppliers ........................................................ 10-2
10.1 Local Approval Requirements for New Cleaning and Sanitizing Chemicals and Suppliers ............... 10-2
10.1.1 PepsiCo Cleaning and Sanitizing Chemical Supplier Requirements .................................. 10-2
10.1.2 Regulatory Requirements for Local Approval of New Sanitizing Chemicals ........................ 10-4
10.2 Corporate Approval Requirements for New Cleaning and Sanitizing Products, Technologies,
and Platforms ............................................................................................................................................. 10-5
10.2.1 Facility Assessment and Trial Protocols for Approval of New Cleaning and Sanitizing
Products, Technologies, and Platforms ........................................................................................................ 10-6
10.2.1.1 Facility Assessment ...................................................................................... 10-6
10.3 Trial Protocol for the Evaluation of New Cleaning and Sanitizing Chemicals ................................. 10-10
10.4 CIP Validation Protocols for Approved Cleaning and Sanitizing Chemicals ................................... 10-11
10.4.1 3-Step Cold CIP Facility Validation Protocol ................................................................... 10-11
10.4.1.1 Purpose and Scope ......................................................................................10-11
10.4.1.2 Category 1 and 2 Producing Lines (3-Step Cold CIP) .....................................10-12
10.4.1.3 Category 3 and Bottled Water Lines (3-Step Cold CIP) ..................................10-13
10.4.2 3-Step Hot CIP Facility Validation Protocol..................................................................... 10-15
10.4.2.1 Purpose and Scope ......................................................................................10-15
10.4.2.2 Category 1 and 2 Producing Lines (3-Step Hot CIP) ......................................10-15
10.4.2.3 Category 3 and Bottled Water Producing Lines (3-Step Hot CIP) ...................10-16
10.5 References................................................................................................................................... 10-17
Chapter 11: Hygienic Design .................................................................................................. 11-1
11.0 Hygienic and Sanitary Design ......................................................................................................... 11-2
11.1 Background .................................................................................................................................. 11-2
11.2 Hygienic Design: Buildings and Infrastructure ............................................................................... 11-2
11.2.1 General Site and External Surfaces Requirements ........................................................... 11-2
11.2.2 External Surfaces ............................................................................................................ 11-3
11.2.2.1 Production Areas .......................................................................................... 11-3
11.2.3 Internal Surfaces ............................................................................................................. 11-4
11.2.3.1 Internal Surfaces – Wet Production Areas ..................................................... 11-4
11.2.3.2 Internal Surfaces – Dry Production Areas ...................................................... 11-4
11.2.3.3 Internal Non-Production Areas ...................................................................... 11-5
11.2.4 Structures, Platforms and Walkways ............................................................................... 11-5
11.3 Hygienic Design: Equipment .......................................................................................................... 11-5
11.3.1 CIP Tanks........................................................................................................................ 11-6
11.3.2 Process Tanks ................................................................................................................. 11-6
11.3.3 Valves ............................................................................................................................. 11-8
11.3.3.1 Butterfly Valves ............................................................................................ 11-8
11.3.3.2 Diaphragm (Membrane) Valves...................................................................... 11-8
11.3.3.3 Valve Seats ................................................................................................... 11-9
11.3.3.4 Double Seat Valves ......................................................................................11-10
11.3.3.5 Metal-to-Metal Valve Seats ...........................................................................11-11
11.3.3.6 Steam Barriers ............................................................................................11-11
11.3.3.7 Aseptic Valves ..............................................................................................11-12
11.3.3.8 Important Remarks about Valves .................................................................11-12
11.3.4 Heat Exchangers ........................................................................................................... 11-13
11.4 Welding /Finishing Quality ......................................................................................................... 11-13
11.4.1 Checklist for Hygienic Welds .......................................................................................... 11-15
11.5 Piping Design/ Avoidance of Dead Legs ....................................................................................... 11-16
11.5.1 Important Points for Hygienic Piping Design .................................................................. 11-21
11.6 Drain Design ............................................................................................................................... 11-22
11.6.1 Important Points for Drain Design ................................................................................. 11-22
11.6.2 Grouped Drains ............................................................................................................. 11-23
11.6.2.1 Rules for Assembling Grouped Drains ..........................................................11-23
15.1.1 CIP Frequency for Product Contact (Internal) Surfaces ..................................................... 15-2
15.1.1.1 Product Contact Surface Cleaning and Sanitizing Frequency (Maximum) ........... 15-3
15.2 CIP Extension Protocols................................................................................................................. 15-5
15.2.1 General Extension CIP Protocol (24-hour intervals) .......................................................... 15-6
15.2.1.1 Prerequisites ..................................................................................................... 15-6
15.2.1.2 Step 1: Baseline (Extending from 24 hours to 48 hours) ................................ 15-6
15.2.1.3 Step 2: Test (Extending from 24 hours to 48 hours) ...................................... 15-6
15.2.1.4 Step 3: Validation (Extending from 24 to 48 hours) ....................................... 15-7
15.2.1.5 Step 4: Monitor (Extending from 24 to 48 hours) ........................................... 15-7
15.2.2 Bottled Water CIP Extension Sampling Sites .................................................................... 15-8
15.2.2.1 Step 1: Baseline Sample Site ......................................................................... 15-9
15.2.2.2 Steps 2 (Test), 3 (Validation), and 4 (Monthly) Sample Sites..........................15-11
15.2.3 Extended Aseptic Bottle CIP Protocol ............................................................................. 15-12
15.2.3.1 Prerequisites ....................................................................................................15-12
15.2.3.2 Step 1: Baseline (Extending from 24 hours to 48 hours) ...............................15-12
15.2.3.3 Step 2: Test (Extending from 24 to 48-hours) ...............................................15-13
15.2.3.4 Step 3: Validation (Extending from 24 to 48-hours) ......................................15-13
15.2.3.5 Step 4: Monitoring .......................................................................................15-13
15.2.3.6 Steps 1 to 4: Sample Site .............................................................................15-14
15.2.3.7 Sampling of Empty Sterile Capped Bottles ...................................................15-14
15.2.3.8 Sampling of Sterile Water .............................................................................15-14
15.2.3.9 Sampling of Surface Swabs ..........................................................................15-15
15.2.3.10 Sampling of Air Open Plates .........................................................................15-15
15.2.3.11 Sampling of Sterile Caps ..............................................................................15-15
15.2.3.12 Environmental Air Limits: ............................................................................15-16
15.3 Process Downtime ....................................................................................................................... 15-16
15.3.1 Cleaning and Sanitizing Frequencies Following Unplanned Process Downtime* .............. 15-17
15.4 CIP Frequencies .......................................................................................................................... 15-18
15.4.1 External Surface Cleaning and Sanitizing Frequency ..................................................... 15-18
15.4.2 Glass Bottle Washer Cleaning and Sanitizing Frequency ................................................ 15-19
15.5 CIP Changeover Guidelines ......................................................................................................... 15-20
15.5.1 Minimum Sanitation Procedures for Product Changeovers ............................................. 15-21
15.5.2 Changeover Guidelines for Syrup or Batch Tanks .......................................................... 15-22
15.5.3 Changeover Guidelines for Syrup Lines and the Filling Process ...................................... 15-22
Appendix 1: Changes in Version 5 ………………………………………………….……………………APP-1
Chapter 1: Introduction
Abstract
The PepsiCo Beverage Sanitation Manual has been published to ensure the consistent
implementation of sanitation principles and practices for beverage manufacturing facilities.
The manual provides a single point of reference for key sanitation information for beverage
manufacturing facilities. The purpose of the manual is to provide PepsiCo facilities and
employees specific sanitation information related to the principles of contamination, cleaners,
sanitizers, and cleaning equipment that is required to ensure the manufacturing of safe
products that are produced within a safe environment.
The PepsiCo Food Safety Policies identifies sanitation programs as a critical food safety
element and outlines key requirements for sanitation to ensure all products for PepsiCo are
manufactured under conditions and within facilities that are sanitary and in compliance with
Good Manufacturing Practices. Within the food industry, sanitation is the creation and the
maintenance of hygienic conditions in the manufacturing of safe and wholesome food
products. Food manufacturing companies have both legal and ethical responsibilities in
providing the consuming public with foods that are safe and wholesome. It is the
responsibility of the facility to guarantee that the beverage is produced in the most sanitary
manner possible. Sanitation is the responsibility to:
1. Provide safe and wholesome food processed, prepared, merchandised, and sold in
a clean environment by workers.
2. Prevent contamination with microorganisms that can cause food-borne illness.
3. Minimize the growth of food spoilage microorganisms.
4. Minimize cross-contamination with an allergen during product changeover, and
where relevant, minimizing the use of product advisory labeling.
Sanitation is an applied science that incorporates the principles of design, development,
implementation, maintenance, restoration, and/or improvement of hygienic practices. As
such, the responsibilities are shared amongst various groups including product development,
facility and equipment hygienic design, as well as operations based on the following
guidelines:
Product Development – Products must be designed to be capable of achieving safe and
wholesome standards within the manufacturing environment.
Facility and Equipment Hygienic Design – The facility site, layout, construction, design,
and equipment must be appropriate and hygienically designed for the safe and wholesome
manufacturing of foods. Equipment must be designed to ensure it can be cleaned, inspected,
and verified.
Operations – Procedures and frequencies for cleaning and sanitizing must be established and
validated to include the appropriate resources. In addition, adequate and appropriate training
programs must be in place to support Sanitation.
1.0 Overview
The PepsiCo Beverage Sanitation Manual has been published to ensure the
consistent implementation of sanitation principles and practices for beverage
manufacturing facilities.
1.1 Purpose
The PepsiCo Beverage Sanitation Manual provides a single point of reference for
key sanitation information for beverage manufacturing facilities. The purpose
of the manual is to provide PepsiCo facilities and employees specific sanitation
information related to the principles of contamination, cleaners, sanitizers, and
cleaning equipment that is required to ensure the manufacturing of safe
products that are produced within a safe environment. Plant personnel will be
able to reference this manual for the following information:
Principles of a Beverage Sanitation Program
Principles of Beverage Microbiology and Sanitation Classification
Principles of Cleaning and Sanitizing Objectives, Agents, Influencing
Factors, and Applicable Methods
Principles of CIP and SIP System and Hygienic/ Sanitary Designs
Summary of PepsiCo-Approved Cleaning and Sanitizing Protocols for
Product Contact Surfaces
Summary of PepsiCo-Approved Cleaning and Sanitizing Protocols for the
facility, environment, and structures (non-product contact surfaces)
Summary of CIP System Validation and Verification of Control Points
Summary of Cleaning and Sanitizing Frequencies Including Protocols,
Optimizations, and CIP Extensions
Principles of Environment, Health, and Safety Protocols for Facility
Sanitation
Summary of PepsiCo’s Sanitation Chemical and Supplier Approval
Requirements
1.1.1 Scope
The structure of the PepsiCo Beverage Sanitation Manual is as follows:
Chapter 1: Introduction
Chapter 2: Beverage Sanitation Program
Chapter 3: Beverage Microbiology
Chapter 4: Cleaning
Chapter 5: Sanitizing and Sterilizing
Chapter 6: CIP System Design
Chapter 7: Sanitation Protocols
Chapter 8: Validation and Verification of Sanitation
Chapter 9: Environment, Health, and Safety
1.1.3 Approval
This manual has been approved by PepsiCo Global Food Safety, which includes
representatives from each PepsiCo sector. Additional input into the manual
was provided by key PepsiCo beverage sanitation chemical suppliers and
Commercial Food Sanitation, LLC. Please direct any questions or comments
regarding this manual to Becky Michaels (Becky.Michaels@PepsiCo.com).
1.4.3 Operations
Process and sanitation equipment must be maintained in good condition
to ensure safe and wholesome food manufacturing.
Adequate and appropriate training should be provided to ensure effective
knowledge of GMPs, cleaning and sanitizing, and safe use of
cleaning/sanitizing agents where appropriate.
The frequency for cleaning and sanitizing must be established and
validated to ensure safe and wholesome food manufacturing.
Appropriate resources should be made available for process cleaning and
sanitizing, to include people, time, equipment, cleaning/sanitizing agents
and sanitation tools.
Compounds recommended for cleaning and sanitizing must be
compatible with the equipment and manufacturing environment. The
cleaning and sanitizing agents must be approved for food contact use,
meeting local regulatory standards and regulatory standards for the
country of product distribution.
Containers that are used to transport cleaning and sanitizing agents
must be properly labeled.
Procedures for cleaning and sanitizing within the MSS and the SSOP
must be written clearly and validated with ongoing verification.
The MSS shall specify the frequency and responsibility for the sanitation
of all equipment, structures, and the surrounding environment which
may impact food products.
pathogenic.
BIODEGRADABILITY The capability of organic matter to be decomposed by biological
processes.
BIOFILM A complex film that includes outer layers of dead
microorganisms that may protect the inner living
microorganisms from sanitizers.
B.O.D. (BIOCHEMICAL Refers to the quantity of oxygen utilized in the oxidation of
OXYGEN DEMAND) organic matter in wastewater by microorganisms in a specific
period of time (usually five days) and at a specific temperature
(usually 20C or 68F).
BUDDING A form of reproduction of many yeasts and molds involving the
formation of a small protrusion from a mother cell. The
protrusion (bud) gradually increases in size and separates,
forming another cell.
CATIONIC SURFACTANT A surface active agent that has an active, positively charged ion
called a cation.
CHELATING AGENT Organic chemicals added to cleaners to prevent the
precipitation of hard water salts.
CLEAN IN PLACE (CIP) The cleaning of equipment by recirculation of cleaners without
disassembly of the equipment being cleaned.
COAGULATION Formation of clot or gelatinous mass.
C.O.D. (CHEMICAL A measurement of the quantity of oxidizable components in
OXYGEN DEMAND) water. This includes biodegradable and non-biodegradable
organic matter and oxygen consuming capacity of inorganic
matter.
COLIFORM BACTERIA Rod-shaped, Gram-negative, non-spore-forming organisms
pertaining to the bacteria that inhabit the intestines (especially
the colon) of mammals. It is the commonly used bacterial
indicator of sanitary quality of foods and water.
COLONY Mass of cells visible to the naked eye, usually on an agar plate
resulting from reproduction of a single bacterial or yeast cell or
mold spore.
COLONY-FORMING UNIT One bacterial cell that has multiplied into a visible colony.
(CFU)
CONTAMINATION Entry of undesirable organisms or materials into a substance.
CULINARY STEAM Steam that is free of entrained contaminants, is relatively free
of water in liquid form and is suitable for use in direct contact
with food products, other comestibles, or product contact
surfaces. The key requirements are using a 2-micron filter,
stainless steel piping after the filter to the point of use and
limits on the type of boiler feed water chemicals that are
allowed to be used.
1.6 References
International Society of Beverage Technologists (ISBT) Sanitation Manual,
2005
Ecolab, Making the Right Choice, Cleaners, 2003
Ecolab, Making the Right Choice, Clean-in-Place (CIP) Systems, 2003
Food Plant Sanitation, Hui, Y.H.; et al 2003
2.1.1 Product
Sanitation programs for production and processing equipment should ensure
thorough cleaning and sanitizing of all surfaces that come in contact with the
beverage or any of the ingredients used in its preparation including primary
packaging.
All manufacturing equipment and its surrounding manufacturing environment
(not only product contact areas) shall be cleaned at a frequency that
demonstrates control. These other areas include underneath conveyors,
platform areas, etc. This applies to Sections 2.1.2 and 2.1.3 as well.
Gaskets that present cracks and cervices must have more intensive
evaluation about maintenance intervals and material application.
Sanitation must collaborate with maintenance and communicate if
anything mechanical needs attention, even if it falls outside of a
preventive maintenance (PM) activity/event.
Spray balls, pipes, clamps, couplings and connections must be
completely disassembled to allow proper cleaning and inspection.
The second general area of the MSS is maintenance cleaning. Maintenance
cleaning ensures that appropriately trained personnel from the maintenance
department conduct cleaning activities, where appropriate, and that
maintenance activities and repairs do not create a source of potential
contamination or compromise product safety.
Whenever possible, maintenance activities should be scheduled around
sanitation events to ensure a detailed cleaning is performed by sanitation on
the equipment/area being worked on. If PIC and PEC frequencies are
established alongside PM frequencies, this can provide an efficient and robust
MSS.
During maintenance, cleaning personnel should meet the following
requirements:
Maintenance debris created during repairs should be quickly removed.
Small items that could contaminate the product must be accounted for
including nuts, bolts, washers, wire pieces, tape, etc.
No grease smears or excess lubricant should be left on the equipment.
Clean tools and cloths are to be used within product zones.
The use of cleaning utensils that may create debris such as wire
brushes, sponges, and scrub pads should only be used if absolutely
necessary. When used, the area must be inspected after use to identify
and eliminate any remaining debris that could contaminate the product.
Food contact surfaces must be thoroughly cleaned and re-sanitized by
trained employees.
Authorized By:
3.3.1 Bacteria
Bacteria are single-celled organisms, ubiquitous, and capable of rapid growth.
Bacteria reproduce asexually by binary fission or simple division of the cell
and its contents. The doubling time, or generation time, can be as short as
20 minutes. Since each cell grows and divides at the same rate as the parent
cell, this could translate to an increase from one to 10 million cells in 11 hours
under favorable conditions.
Note: Bacterial populations are expressed as colony-forming units (CFUs) per
gram or milliliter.
Some bacteria have the ability to form resisting cells known as endospores.
The spore forms in times of environmental stress, such as lack of nutrients and
moisture needed for growth, and thus is a survival strategy. Spores have no
metabolism and can withstand adverse conditions such as heat, disinfectants,
and ultraviolet light. When the environment becomes favorable, the spore
germinates, giving rise to a single vegetative bacterial cell. Some examples of
spore-formers important to the food industry are members of Bacillus and
Clostridium genera.
Clostridium botulinum spores are a concern for hermetically sealed processed
foods. The spores are very heat-resistant and require very high processing
conditions, such as retorting or canning to minimize their risk. In food
products with pH >4.6, if not adequately processed and under anaerobic
conditions, the heat-resistant spores may survive and grow with the potential
of producing a heat-stable neurotoxin, which can be potentially fatal if
consumed in foods.
Bacillus cereus is a spore-forming bacterium that can be frequently isolated
from soil and some food. Bacillus foodborne illnesses occur due to survival of
the bacterial endospores when food is improperly cooked and improperly
refrigerated, allowing endospores germination with resulting growth and
production of heat-resistant enterotoxins. Unlike C. botulinum, the toxins
produced are not fatal, but may lead to two types of illness, diarrheal and
emetic (vomiting) syndrome. B. cereus can grow at pH values of between 4.3
and 9.3, and can grow at water activity values down to 0.91, and often are
associated with improper refrigeration of starchy foods such as rice and
pudding.
Aciduric bacteria/ Acetic Acid bacteria (such as Acetobacter and Gluconobacter),
and Lactic Acid bacteria (such as Lactobacillus and Leuconostoc) are of concern
for non-carbonated beverages, juices, tea, and flavor concentrate. They are
resistant to preservatives and can grow at a low pH.
Some bacteria, such as Alicyclobacillus acidoterrestris (Thermo-acidophilic
Bacteria -ACB), produce heat-resistant spores and can be a concern for
beverage and juice products requiring thermal processing, with the spores
being able to survive through pasteurization temperatures. Spoilage of a
beverage with ACB may result in a unique, “medicinal/cough drop” off-flavor
and odor due to guaiacol production.
Rods: Bacilli (straight rod) or Spirilla 0.25 - 1.0 µm width by 0.5 - 6.0 µm length
(spiral rod)
3.3.2 Yeast
Yeasts are members of a higher group of microorganisms called fungi. They are
single-cell organisms of spherical, elliptical or cylindrical shape, ranging in size
from 1 to 5 µm in width, and from 5 to 30 µm in length. Their size varies
greatly but yeasts are generally larger than bacterial cells. Yeasts may be
divided into two groups according to their method of reproduction:
Budding: called Fungi Imperfecti or false yeasts
Budding and spore formation: Ascomycetes or true yeasts
Unlike bacterial spores, yeasts form spores as a method of reproduction. Yeasts
are widely distributed in nature, common in fruits, grains, and other foods
containing sugar. They can be found in soil, air, skin, and intestinal tracts of
humans, animals and insects.
The spoilage of beverages by yeast may result in visible sedimentation, gas
production, and deformation of packaging due to increased gas pressure,
off-odor, color, or flavor.
3.3.3 Mold
Molds are commonly found in soil, air, water and foods. Molds are filamentous,
multi-celled fungi with an average size larger than both bacteria and yeasts (10
x 40 µm). Each filament is referred to as a hypha. The mass of hyphae that can
quickly spread over a food substrate is called the mycelium. This
characteristic makes them quite visible to consumers as contaminants.
Mold contamination is most frequently the result of airborne spores, although
contamination from equipment or raw ingredients may also result in mold
growth and spoilage. Spores are the primary means of reproduction in these
fungi and are easily carried by air currents into the processing area. Molds
appear in the beverage plant environment in a variety of forms and colors:
fuzzy, powdery, wet, velvet-like, black, white, green, pink or yellow.
Some molds produce cottony colonies which grow profusely out of the
substrate, while others produce flat colonies.
Molds are everywhere in our environment. Molds need very little to survive and
flourish - air, moisture and food. High water levels are not necessary for growth
as most species propagate with only 40%-60% relative humidity. Molds can be
found in areas such as floors, walls and ceilings. They can propagate in reclaim
and rework areas of a plant.
3.4.1 Background
Laboratory-based microbiological tests (challenge studies) are typically used to
make the critical decisions regarding food safety and product shelf life, when
the growth, survival and inactivation of microorganisms in foods are
reproducible responses.
3.4.2.1 Category 1
Category 1 includes products that are the most robust of the PepsiCo family.
These products have no growth potential, are inhibitory, microcidal to relevant
spoilage organisms and have no pathogenic growth potential. Examples of
Category 1 products include CSDs such as Colas, 7-Ups (preserved), and
Mirindas.
To maintain a successful manufacturing environment for Category 1 products,
minimize process adaptive spoilage growth potentials:
It is required that the manufacturing system and all direct product
contact surfaces are cleaned and sanitized at least once each week (not
to exceed 7 days) at a minimum.
All indirect product contact surfaces and external surfaces are also
required to receive a PepsiCo-approved sanitation procedure at a
frequency not to exceed once each week (not to exceed 7 days).
All seals, gaskets, vent tubes, replacement valves, etc. must receive
inspection and COP prior to installation; damaged parts and gaskets
should be replaced.
Appropriate measures must be taken between flavors, sugars and diets
to prevent cross-contamination.
Effectiveness of the CIP must also be verified using in-plant testing to
include sensory testing, visual inspection, and microbiological or ATP
analyses.
Further details and requirements can be found in Chapter 7: Sanitation
Protocols and Chapter 8: Validation and Verification of Sanitation.
3.4.2.2 Category 2
Category 2 products are more sensitive to microbiological contamination/
spoilage than Category 1 products. These products have low potential of slow-
growing spoilage organisms (measured in months) and no pathogen growth
3.4.2.3 Category 3
Category 3 includes the most sensitive products in the PepsiCo family that can
be routinely produced using conventional cold fill technology. Category 3 are
products with micro spoilage growth potentials (as measured in weeks), relying
on strict manufacturing hygiene and/or production run times. There is no
pathogen growth potential. Some examples of Category 3 products include
CSDs without preservation (i.e., 7-Up unpreserved), Tropicana Twisters
preserved cold-fill, Lipton Brisks, Lipton Iced Teas, and Pepsi Natural.
To maintain a successful manufacturing environment for Category 3 products,
minimizing process adaptive spoilage growth potentials:
The facilities to produce Category 3 products must be qualified per line
by demonstrating successful completion of three consecutive run-and-
hold production qualification runs after meeting all start-up
requirements. Further details and requirements can be found in the
Category 3 Beverage Requirement documents.
Category 3 production lines must have automatic CIP systems with a
continuous recording of parameters.
3.4.2.4 Category 4
Category 4 includes products that are too sensitive to be routinely produced in
PepsiCo plants using conventional cold filled processing technology. Typically,
Category 4 products require alternative product processing such as
pasteurization, ozonation or other means such as hot fill or aseptic processing.
Category 4 products have spoilage potential with fast growth potential
(measured in days) for yeast, mold and bacteria. There is no pathogen growth
potential although pathogens could survive if the product is not processed
adequately. Category 4 microbiological limits as well as cleaning and sanitation
Version 5 April 2019 Page 3-18 of 20
PepsiCo Beverage Sanitation Manual Chapter 3: Beverage Microbiology
3.5 References
International Society of Beverage Technologists (ISBT) Sanitation Manual,
2005.
Diversey Beverage Microbiology References, 2008.
Compendium of Methods For the Microbiological Examination of Foods, 4th
Edition, 2001.
Modern Food Microbiology, James M. Jay 1978.
Chapter 4: Cleaning
Abstract
Cleaning is a process which that soils and prevents the accumulation of food residues that
may decompose or support the growth of spoilage, disease-causing organisms, or the
production of toxins. The cleaning process is comprised of four key attributes including Food
Safety, Microbiological Restriction, Quality, and Production Performance. Responsibility for
cleaning and maintaining all areas of the beverage facility shall be assigned through
maintenance and cleaning schedules. Plant equipment and utensils shall be designed to be
adequately cleanable and properly maintained.
The cleaning agents used must be properly labeled, have food-contact approval
documentation, and be stored in secured areas. Cleaning agents must be effective in the
penetration, dislodgement, and dispersion of the soil through chemical reactions or physical/
chemical interactions. There are many classifications of cleaning agents including:
Alkalis - Soil displacement by emulsifying, saponifying and peptizing.
Acids - Mineral deposit control and removal; water softening.
Surfactants - Wetting and penetrating soils; emulsification and dispersion of soils
and prevention of soil re-depositions.
Complex Phosphates - Soil displacement by dispersion of soil; water softening,
prevention of soil depositions.
Polyelectrolytes - Dispersion of precipitates formed during the formation of deposits
when hard water comes out of solution during the application of heat.
Chelating Compounds - Water softening; mineral deposit control. Prevention of re-
depositions.
Oxidizing Agents - Improves peptizing action of alkalis and provides bleaching and
dissolving properties.
The primary constituent of all cleaners is water, therefore water quality must be understood
and cleaning agents must be tailored to the water supply. For effective cleaning, water
parameters must be managed accordingly. These parameters include Turbidity, Total
Dissolved Solids, pH, Iron and Manganese salts, Silica, Microorganisms, and Water Hardness
(Temporary and Permanent).
There are several factors that can influence the effectiveness of cleaning. These factors are
critical in successful cleaning and can be summarized in the following acronym, TACT WINS
where Time, Action, Concentration, Temperature, Water, Individual, Nature of the Soil, and
Surface each have a role.
There are two primary types of cleaning methods, manual cleaning and mechanical cleaning.
The simplest form of manual cleaning is the use of a bucket and brush which provides
excellent chemical contact and allows for direct physical agitation of the soil. Foam and gel
cleaning, applying a concentrated detergent to an exterior surfaces, is also common.
Mechanical Cleaning includes Clean Out of Place (COP), which requires the disassembly of
equipment, and Clean in Place (CIP). CIP brings the cleaning solutions to the equipment and
is most effective for large, multi-line facilities.
4.0 Cleaning
4.1 Objectives of Cleaning
Cleaning is a process that will remove soils and prevent accumulation of food
residues that may decompose or support the growth of spoilage, disease-
causing organisms, or the production of toxins.
Objectives of the cleaning process are comprised of the following attributes:
1. Food Safety – pathogens, toxins, or allergen
Examples:
Cleaning liquid egg/batter systems at a defined frequency to prevent
the growth of Staphylococcus aureus and the production of heat-
stable enterotoxins.
To minimize allergen cross-contamination when switching from one
allergen-containing beverage to either a beverage without an allergen
or a beverage with a different allergen.
2. Microbiological Restriction- when buildup of spoilage organisms in the
equipment results in an end product that is out of microbiological
standards.
Examples:
Removal of biofilm.
When the growth rate of microorganisms exceeds design standards for
processing.
3. Quality – Removal of residual compounds which may contaminate the
product to be produced or when switching over to other products.
Examples:
Changeover quality attributes (i.e. pungent beverage to less pungent
beverages).
Changeover from products that are physically or organoleptically non-
compatible with current product being produced.
Removal of biofilms.
Breaking the adaptive cycle of microorganisms.
4. Production Performance - when physical restriction, pollution hampers
the optimal technical performance of the process.
Examples:
Fouling of plate heat exchangers.
Physical restriction of pipes and filling nozzles.
Buildup on surface of tanks and vessels (i.e. soap stones, calcium
deposits).
Surfactants 3 2 2 4
Complex Phosphates 1 1 2 1
Polyelectrolytes 0 0 0 0
Chelating Compounds 0 0 3 0
Oxidizing Agents 0 4 0 0
(Chlorine)
Cleaning Agent Effectiveness
4 = Excellent, 3 = High, 2 = Medium, 1 = Low, 0 = None
Note: Gums have been shown to be removed by solvents and in some cases acetic acids;
Solvents are flammable.
the lines, and that the rinse water used to remove it checks out negative to
phenolphthalein (no color change).
CAUTION!
Because hot caustic (sodium hydroxide) is so dangerous, it is not
recommended as a sanitizing agent unless it is being executed by fully
trained sanitation staff, and all safety precautions are in place.
Potable 100% Usually contains Solvent and carrier for soils, as well as
water dissolved air and chemical cleaners. Hard water leaves
soluble minerals deposit on surfaces. Residual moisture
in small amounts may allow microbial growth on washed
surfaces. Promotes rusting of iron.
Strong 1%-2.5% Sodium Use water with a minimum flow rate of:
alkalis hydroxide 1.5 m/sec (or 2 m/sec if at ambient).
(caustic) and Detergents for fat and protein. Precipitate
orthosilicate water hardness. Produce alkaline pH.
Highly corrosive. Difficult to remove by
rinsing. Irritating to skin and mucous
membranes.
Organic acids 0.1% - 2.0% Acetic, hydroxyacetic, Remove inorganic precipitates and
lactic, gluconic, citric, other acid-soluble substances from
tartaric surfaces. Moderately corrosive, but
can be mediated through addition of
organic nitrogen compounds.
microbial levels any greater than those associated with the potable water
supply. Potable water can contain low levels of bacteria, yeast or mold.
T A W I
C T N S
4.4.1 T – Time
Generally speaking, the longer the cleaning solution is allowed to contact the
soil, the better.
Note: Different chemicals have different contact times. Consult chemical
vendors/suppliers to ensure optimum contact time is allowed. Industry
guidelines are between 10-15 minutes before rinsing off.
Soil is usually removed more rapidly at the beginning of the cleaning process,
when the soil is being removed from the surface layers of soil, than the end.
The reason for this is at the end of the cleaning cycle it is usually more difficult
to break the bonds between the soil and the surface being cleaned.
4.4.2 A – Action
Action greatly enhances soil removal. Action can either be manual from
scrubbing or mechanical from turbulent flow generated in a CIP (Clean in
Place) system or COP (Clean out of Place) tank. During CIP, flow rates are to be
measured to ensure the appropriate action is taking place.
4.4.3 C – Concentration
In general, as the concentration of the cleaner is raised, cleaning becomes more
effective. Essentially, there is more chemical available to break the bonds
holding the soils to the surface. There is a point, however, when an increase in
concentration provides no added benefit, and, in fact may cause precipitate
formation and reduce the efficiency of the detergent. Here it is always
important to confirm the supplier’s recommended use concentrations by
referring to the technical data sheets that are provided by the supplier.
4.4.4 T – Temperature
There is a law in chemistry stating that a molecule’s speed doubles every time
the temperature is raised 10 ºC; likewise in cleaning. Cleaning efficiency is
greatly enhanced at elevated temperatures (140 ºF/60 ºC). But here again,
there are limits to how high the temperature can be raised. At temperatures
above 165 ºF/72 ºC there can be problems with the breakdown of sodium
hypochlorite (NaOCl) and denaturing of proteins soils. High temperatures can
also cause deposits to burn onto the food-contact surface. On the other hand,
there are detergents that are formulated to be used at 185 ºF/85 ºC. It is
always important to confirm the correct temperature based on the supplier’s
recommendation or corporate operating instructions.
4.4.5 W – Water
Salts, primarily calcium and magnesium carbonate, are responsible for water
hardness. Their presence, in water with high concentrations of these salts, can
greatly reduce the performance in the detergent. In addition, when hard water
is heated, these salts will precipitate, which will result in the formation of a
difficult-to-remove scale. The use of detergents with specially formulated water
conditions and sequestrants (chemicals capable of binding calcium or
magnesium) will help control water hardness. It is also a good preventive
practice to periodically assure that there is a proper match between the plant’s
water hardness and the type of detergent and concentration being used.
4.4.6 I – Individual
The people who do the work are the heart of any sanitation program. It is
important to make sure that individuals understand the procedures, have the
proper chemicals, equipment and time for an effective and efficient sanitation
program.
Figure 4-3. Protein films inside a batch tank (left) and Iron stains inside a
storage tank (right).
4.4.8 S – Surface
Most processing equipment in beverage facilities is type 304 stainless steel.
304 stainless steel is resistant to typical detergents and sanitizers we use for
cleaning and sanitizing. Softer metals – brass, aluminum and bronze – are
much more susceptible to corrosion, pitting and general chemical attack.
Detergents specially formulated with corrosion inhibitors and other protective
agents should be used with these soft metals.
The smoothness or roughness of the surface will also influence the integrity of
cleaning. For example, surfaces that are pitted or excessively rough, will harbor
small niches and become problematic. These surfaces may appear visually
clean but may not be microbiologically clean or allergen free.
Time Time
Action Action
Concentration
Concentration
Temperature
Temperature
surface. When rinsing from the top water cascades and aid the rinsing.
Make sure the undersides of equipment are being reached.
2. Avoid the “Fire Hose Effect” in Rinsing: If rinsing with water pressure
too high, soils and microorganisms are aerosolized and redeposit on
clean equipment.
3. Work Small Sections: In order to avoid the foam from drying, work in
small sections.
4. Foam Should Not Be Too Wet or Too Dry: The wetness or dryness of
the foam can be adjusted with the amount of air. The best foams are a
compromise between wet and dry foams. Ideal foam will hang on the
surface the longest amount of time.
5. Maximum Hose Length to about 60 feet: At lengths longer the 60 feet,
the foam will tend to collapse in the hose.
6. Be aware of Surfaces (i.e. Aluminum): Chlorinated alkaline or caustic
foam products can damage aluminum or other soft metals.
7. Avoid Foaming of Hot Surfaces: When a surface is hot, water will flash
out of the foam matrix and cause extreme filming, which can be very
difficult to remove.
8. No Advantage of Using Hot Foam Solutions: If hot foam solutions are
used, they dry quickly and cause streaking. Hot foaming also causes
more condensate in the area.
There are several different types of systems that can be used for foaming. These
include foaming units that are portable, wall mounted, or centralized systems.
Below are examples of the different types of foaming systems that are available:
Figure 4-7. Portable Foam System (left) and Wall-Mounting Foam System
(right).
COP techniques are widely applied to reduce cleaning labor costs and provide
most effective cleaning of complicated equipment parts. This procedure is
based on the use of a recirculation tank equipped with a high-volume
recirculation pump. Processing equipment adaptable to this type of cleaning
includes the following:
Filler valves
Gaskets
Pump housing and impeller
Fittings and auxiliary equipment
Note: Any piece of equipment that can be put inside the COP tank, should
be placed there for cleaning, especially if the equipment has small openings
that cannot be manually cleaned. Examples include blade/slicer heads,
heat-resistant product contact belts, support rollers, etc.
Short sections of pipes or hoses are not applicable for CIP
4.6 References
International Society of Beverage Technologists (ISBT) Sanitation Manual,
2005
Diversey Beverage Microbiology References, 2008
Ecolab, Making the Right Choice, Cleaners, 2003
Ecolab, Making the Right Choice, Clean in Place (CIP) Systems, 2003
Food Plant Sanitation, Hui, Y.H.; et.al. 2003
Disinfecting is the process of killing pathogenic organisms and does not destroy
spores. The main difference between a sanitizer and a disinfectant is that at a
specified use dilution, the disinfectant must have a higher kill capability for
pathogenic bacteria as compared to that of a sanitizer.
Sanitizing has the aim of eliminating relevant organisms (i.e. potential spoilage
or pathogenic organisms) in the process equipment which have not been
quantitatively removed by the proceeding cleaning procedure.
However, studies have shown that it is difficult, if not impossible, to sanitize a
dirty surface. If a cleaning cycle has not been effective in removing soils from
surfaces, sanitizing chemicals will not be effective in eliminating residual
microorganisms. Bacteria may form a biofilm, in which the outer dead layers of
microorganisms may protect the inner living microorganisms from sanitizers.
In addition, organisms produce a slime layer that provides a protective barrier
for inner microorganisms.
flavor, odor and visual characteristics. Sanitation within the beverage industry
can be accomplished through the application of anti-microbial chemical agents,
or through the use of heat. Therefore, both chemical and physical sanitizing
agents can be used to sanitize food-contact surfaces, the choice will depend on
the particular application and the effectiveness required.
5.3.1.1.1 Chlorine
Chlorine is the most frequently used sanitizing agent in beverage plants. It is
effective against a wide variety of bacteria, fungi, and viruses including
bacteriophage, and therefore, it has broad antimicrobial activity. Chlorine’s
bactericidal properties are thought to include the reaction of certain oxidizable
groups in vital enzyme systems. One weakness of chlorine is that it cannot
penetrate into cracks in gaskets, or hard to reach areas, unless the equipment
is flooded and the problem areas are identified and corrected. Aside from this,
chlorine is an excellent sanitizing agent with good kill efficiency.
Chlorine should be used at a pH of approximately 6 - 8. It is not affected by
hard water salts unless they cause an upward drift in the pH of the use
solution. In addition, chlorine is effective at fairly low temperatures and is not
as temperature sensitive as other common sanitizers. Chlorine has the
advantage of being relatively inexpensive and is often preferred because it does
not foam.
The disadvantages of chlorine sanitizers include the potential for toxic gas
formation and can be corrosive to many metals. Chlorine products will degrade
with age and therefore need to be prepared more frequently than other
sanitizers.
Inorganic chlorine is readily available in two basic forms - calcium
hypochlorite, usually at strength of 70 percent available chlorine, and sodium
hypochlorite, usually at strength of 15 percent available chlorine. Chlorine gas
may offer economic advantages, but requires special precautionary measures.
5.3.1.1.5 Iodophors
Iodophors are compounds that contain iodine complexed with a surfactant
carrier and an acid. The surfactant carrier provides a soluble, stable medium
for the iodine and in the diluted form controls the release of iodine. The
surfactant carrier also aids in penetration into organic soils.
Iodophors are known to provide broad antimicrobial activity including yeasts
and molds. They provide a weak acid rinse for mineral control and are less
irritating to the skin than chlorine. In addition, Iodophors offer low toxicity and
have a broader effective pH range than chlorine. In general, they are more
effective at pH 2-5 and offer acceptable sanitizing efficacy at slightly alkaline
pH, depending on the formulation and conditions. Iodophors are less corrosive
than chlorine when used below 120 °F and their activity is not lost as rapidly
as chlorine in the presence of organic matter, especially at low pH.
There are some disadvantages to using Iodophors. For example, they may be
more adversely affected by water hardness than chlorine and they have poor
activity against bacteriophage. In addition, Iodophors can result in sensory
staining. The efficacy of Iodophors is adversely affected by low temperatures
and they cannot be used above 120 °F or on hot equipment. This would cause
the iodine to vaporize, which would be very corrosive to the equipment. For this
reason, Iodophors are not commonly used as a beverage CIP sanitizer.
are cationic molecules, they are incompatible with soaps and anionic
detergents. For this reason, surfaces must be rinsed thoroughly between the
cleaning and sanitizing steps to prevent the inactivation of the QAC. QACs are
not as effective at low temperature as is chlorine or peroxyacetic acid. QACs are
not recommended for beverage CIP because when used in mechanical
operations they can cause foaming problems.
* Not recommended for CIP due to one or more of the following reasons: 1) does not meet definition of
sanitizer—must result in a five-log (99.999%) reduction of the organism of interest in 30 seconds or less
under the conditions of test, 2) staining, 3) poor rinsability, 4) potential adverse sensory effects on the
beverage.
** Consult the chemical representative for recommended concentration.
Note: If Imperial gallons are used, multiply the above ounces of chlorine
compound to be used by 1.2.
The following formula can be used to determine fluid ounces of chlorine needed
based on available chlorine content of chlorine stock. The factor of 128
converts gallons (U.S.) to fluid ounces (U.S.):
Gallons solution needed X ppm chlorine desired X 128 = fluid ounce needed
% available chlorine in stock solution expressed in ppm:
Example
Gallons of solution desired 100
Chlorine desired in ppm 100 ppm
% available chlorine in stock solution 15 %
Then:
100 X 100 X 128 = 8.5 fluid ounces
150,000 ppm (15%)
The following formula can be used to determine liters of chlorine needed based
on available chlorine content of chlorine stock.
Liters solution needed X ppm chlorine desired liters desired = liters needed
% available chlorine expressed in ppm:
Example
Liters of solution desired 1,000
Chlorine desired in ppm 100 ppm
% available chlorine in stock solution 15%
Then:
1000 X 100 X ppm = 0.66 liter of 15% sodium hypochlorite
150,000 (15% )
Note:
For Low-Acid Foods: 5 log reduction for food contact surfaces, 4 log
reduction for non-food contact surfaces
For High-Acid Foods: 4 log reduction for food contact surfaces, 3 log
reduction for non-food contact surfaces.
5.7 References:
International Society of Beverage Technologists (ISBT) Sanitation Manual,
2005
Diversey Beverage Microbiology References, 2008
Ecolab, Making the Right Choice, Sanitizers, 2003
Food Plant Sanitation, Hui, Y.H.; et al 2003
Inside Aseptic, Process Engineering GEA Procomac 2008
6.1.1 Background
The cleaning and sanitizing of large processing equipment require the use of
systems and processes that bring cleaning and sanitizing solutions to the
equipment. This concept is known as CIP. CIP is a method of cleaning the
interior surfaces of pipes, vessels, process equipment, filters and associated
fittings. CIP systems use fixed pipes (lines), spray devices, valves, tanks,
sensors and controls, to provide a “closed circuit” cleaning and sanitizing
process.
CIP systems offer significant advantages over other cleaning methods,
including reduced labor as well as energy and water savings while providing
better results due to the ability to use higher temperatures and concentrations
than open systems. The “automatic” programming feature of most CIP systems
provides a degree of repeatable performance not found in other cleaning and
sanitizing methods. In addition, since the processing equipment does not need
to be taken apart and reassembled for each CIP, the risk of recontamination is
greatly reduced.
A CIP system has five basic components including a CIP Circuit, CIP Supply
Tank, CIP Pump, Drain Valve, and CIP Return Pump. A completed CIP “circuit”
(also known as the cleaning path) has water flowing through the installed pipes
from the supply tank through the supply pump to the vessel or lines being
cleaned and then back to either the drain or the supply tank for circulation.
There are a number of different types of CIP systems that can be utilized. All
CIP systems require about the same amount of supply-return piping, pumps,
cleaning hook-up stations and sprays. The major difference is in the design,
operation and control of the circulation unit (CIP unit) at the beginning. In
general, CIP systems fall into four categories.
6.1.2 Scope
When purchasing a new CIP system, the beverage facility shall provide the CIP
system manufacturer with all necessary system requirements. The CIP system
manufacturer (or supplier) shall design, furnish, commission, qualify and verify
a CIP system complete with all equipment necessary to provide effective
internal sanitation through all circuits associated with the supplied CIP system
in order to meet the beverage facilities requirements. Additionally, the CIP
system should be able to perform a CIP at its own tanks. In summary, a CIP
tank should be able to perform an auto CIP.
6.1.3 Purpose
Effective Internal Sanitation is accomplished through utilization of a multiple
step procedure in closed-loop systems. Recirculation and balanced flow
throughout CIP circuits are required at optimum flow velocities and flow rates
in each circuit section.
All product lines, where liquid product or raw material passes through, shall be
submitted to a CIP process including syrup tanks, formulation tanks, blenders,
proportioners, deaerators, pasteurizers, fillers, aseptic tanks and their lines
with all components. The list below provides some examples:
1. Syrup and ingredient tanks and their associated piping and valving,
including product contact level gauging hardware and piping.
2. All product contact surfaces of syrup and ingredient receiving, processing
and distribution systems, including pumps, valves, meters, strainers,
pipes and hoses.
3. Filler and beverage processing systems including, proportioners, chillers,
deaerators, carbonators, pumps, piping, and divert panels, when part of
mix processing system.
4. Filler valve caps/harness devices are required for each filler to facilitate
recirculation through filler valves, air-activated snift cams are required
where filler snift is not designed or capable of automated
cleaning/sanitizing.
5. Sweetener silo/ sweetener receiving line/ distribution line to syrup room
– this capability should be included in any redesign, new HFCS or
sucrose system, or new plant builds.
6. Central Deaeration system/ water distribution system (these systems
may require modification in order to be CIP capable).
7. Bottled Water fillers used for production shall be equipped with an
isolated and dedicated supply and return line for the CIP circuit. The
filler is to be isolated from all other mix/ beverage processing equipment
during the CIP process. The filler CIP is to be done separately from mix
processing equipment when the filler is being prepared for bottled water
production. The CIP system shall be piped such that the production
equipment can be cleaned via one of three different circuits:
a The production line dedicated syrup transfer piping, the mix
processor, the filler CSD product pipe, the filler and, if existing, the
filler CIP return tank.
b The production line dedicated syrup transfer piping, the mix
processor and the filler CSD product pipe up to, but not including,
the bottled water supply connection for the filler.
c The filler CSD product pipe from, and including, the bottled water
supply connection to the filler, the filler and, if existing, the filler CIP
return tank.
Note: When the deaerator is not part of the mix processor, it must be designed
to be CIP capable with check valves in place, functional and included in the
preventive maintenance program. If CO2 is used/ scavenged from the mix
processor (product side), the deaerator must be included in the CIP circuit or
fresh CO2 must be utilized (Reflux/ scavenged CO2 transfers yeast, mold, and
bacterial microorganisms into the deaerator).
All other conditions not covered on section 6.1.3 above should be submitted to
the Region/ Sector Quality/ Commercialization contacts responsible for
evaluation and validation.
6.2.2 Regulatory
The supplier shall provide design, materials of construction, manufacture,
inspection and performance testing in conformance with all applicable local,
state and national statutes, regulations and codes in effect at the time of sale
and in conformance with the requirements of IAMFES 3-A Sanitary Standards
#605-04, Accepted Practices for Permanently Installed Product and Solution
Pipelines and Cleaning Systems. Any code deficiencies in existing equipment
affecting the supplier’s equipment/ operation/ system shall be noted by the
supplier and brought to the attention of PepsiCo.
Other conditions that may impact the performance of a CIP system and are not
covered in this section should be further evaluated and validated.
If there are more than two lines in the CIP station, it is recommended to heat
the solutions in the tank rather than in-line (it is more costly to have big heat
exchangers on each line).
Both options are shown in Section 6.5.1.
6.3.5 Deaerator
When the deaerator is not part of the mix processor, it shall be designed to be
CIP capable.
required through all parts of the CIP process is 1.5 m/sec. Turbulent flow
occurs at flow velocities of 1.5 – 2.0 m/sec. For protein-containing beverages,
the Reynolds number should be greater than 100,000 for hot surfaces such as
with UHT, HTST, and the hold tube during CIP cycles.
Figure 6-2. Very efficient, turbulent flow that is approaching plug flow.
Figure 6-3. Insufficient flow that does not provide enough scrubbing.
Figure 6-4. Very poor, partial flow that has entrained air.
Other velocities might be appropriate, depending upon soil/product type
characteristics, design and construction of the processing equipment, etc.
Validate the cleaning effectiveness of lower velocities with methods such as
microbiological swabs, visual inspections, etc.
Adequate flow velocity is required to clean dead ends. Dead ends are defined as
areas within piping that have poor flow and are difficult to clean. Dead ends of
differing lengths and configurations will require different minimum flow
velocities to ensure adequate sanitation. Most situations are dealt with by
limiting dead ends and using minimum flow velocities of 1.5 m/sec. Examples
of dead ends are shown in Figure 6-5.
Dead End
Soil Trap
the CIP System as well as the condensate return from the CIP System
back to the condensate return header.
5. Return Temperature RTD and CT Probe – The temperature probe
measures and records the time and return temperature of the cleaning
and sanitizing solutions. A circular temperature recording chart is often
used. Conductive meter is important to check the concentration of return
solution.
Temperature monitoring is required for all Category 3 and 4 products.
For the sanitizing step, heat strips or thermal scans must be used to
validate the temperatures for each CIP circuit. PepsiCo hot sanitize
specifications require that the external surfaces must reach the target
temperature of 85°C and be held for a consecutive 15 - 20 minutes. CIP
controller must be programmed to begin the timer once the external
surface reaches 85°C, not once the Return RTD sees 85°C.
6. Drain Valves – Drain valves provide control to the direction of flow
through the circuit. Valves are automatic, sanitary, and typically air
operated. All drain valves are to be of a sanitary design and 316L
stainless steel construction.
Any discharge from the CIP system is to be piped to the drain. The drain
system must be capable of handling a maximum flow without flooding.
The CIP System must be located adjacent to adequate drains or a defined
solution must be provided for achieving acceptable drainage.
7. Detergent Feed (Dosing) Systems – The dosing system controls the
supply of cleaners and sanitizers utilizing pumps that deliver the proper
amount and type of chemicals to the cleaning and sanitizing solutions.
The control of concentrations can be based on time or pulse feed or by
conductivity.
8. Controller – The controller controls the functions of the pipes, valves,
and other components while managing the flow times, amounts,
direction through the lines, pressures and safety systems.
9. The Circuit – The circuit includes all the spray devices, lines, valves,
flow controls, necessary hookups, the CIP skid and return pumps to
provide complete, uniform coverage of all surfaces of the equipment or
lines being cleaned. The CIP skid simply supplies water, cleaners and
sanitizers to the circuit. In order to function properly, the circuit must
return what was supplied back to the skid for circulation to take place.
with pulp, a filter is required on the return line to ensure the fiber
particles do not contaminate the CIP circuit. In addition, the automatic
draining of tanks used for fiber containing products should be done
periodically. The facility must have a 100-mesh filter/strainer in the
pressure side, after the CIP pump to ensure that residues or gaskets or
other components cannot return to the line.
Check strainers at minimum weekly after each production run and
cleaning. For allergen cleanings, the strainer shall be checked after
every CIP allergen clean. Strainer checks shall be included as part of
the MSS and PEC cleanings at a frequency that demonstrates control.
4. Supply Temperature – Resistance Temperature Detection (RTD)
Probe – A temperature probe, just beyond the heat exchanger, is a
component of the heating system used to control the temperature of the
outbound cleaning solutions. By using this RTD, the supply
temperature can be recorded easily. This can then be compared to the
return temperature probe, which measures the minimum temperature
to which the equipment was exposed. If there is a significant difference
between the supply and return temperatures, it is easy to identify
issues such as the refrigeration being left on.
5. Sampling Port – A small sampling port is located on the CIP (or return)
to easily collect samples of the cleaning and sanitizing solutions for
testing concentrations. A manual valve can be used or an electric or
air- operated valve and sample holder can be used to collect samples.
6. Supply Pressure Sensor – Monitoring and recording of CIP supply
pressures are very useful and found on most CIP systems. A two-pen
circular chart, recording both the return temperature and supply
pressure, is often used. Pressure fluctuations indicate poor hydraulics;
high pressures indicate a blockage such as a plugged spray device,
while an open circuit would have low pressures.
7. Flow Meter – A flow meter in the supply side is used in setting up and
controlling the flow and volumes in each specific piece of equipment or
circuit. A flow meter, either a vane type or vortex type, is often used. A
flow meter is also required at the return line. If it needs to be installed
at the pressure side, a flow switch (minimal requirement) is requested
at the return line to ensure that the same flow is going is the same
returning and is not filling any tank in the way.
Note: When performing manual velocity checks, the most difficult
circuit to clean shall be selected, and the flow requirement applies to
the largest diameter pipe. The length of the circuit and the soil loading
necessities should also be considered. If the CIP system is equipped
with an in-line flow meter on the return line, the flow meter must be
calibrated at a frequency sufficient to demonstrate control. Velocity
checks should be performed annually, at minimum.
8. Return Check Probe – A probe, located in the return line to confirm
the return of solutions, is used as a safety measure. If no return is
sensed in the first rinse, the CIP program stops and indicates an error.
If an error is made in connecting the CIP system to the equipment being
cleaned, the program will stop after the first water rinse, preventing
chemicals from coming in contact with the wrong equipment.
9. Conductivity Probe – A conductivity probe can be used to measure,
control, and record the conductivity of the cleaners and sanitizers. It
can be placed in the return line or in the supply (wash) tank. If placed
in the return line, it can also be used to monitor, and control rinses,
minimizing water usage or to control product recovery.
10. pH Probe – A pH probe is an additional sensor and can provide
benefits. Most pH probes use a glass electrode and therefore, must be
located in a side stream to prevent the possibility of glass
contamination. If a pH probe is used, it must be calibrated daily and
maintained. Conductivity measurement is superior to pH.
11. Data Acquisition/ Printer – Recording of return temperatures and
times may be required. Two-pen circular charts recording return
temperature and supply pressures have been used for many years.
Modern controllers, PC computer systems and sensors provide a means
of recording a complete picture of each program. Alarms can be
sounded and recorded during the program to alert the operators of
potential problems. The results can be compared to the established
standard values. This provides documentation that can be part of a
quality or food safety program. Summary reports can be generated and
made available to management as needed. In addition, costs can be
monitored by recording the amounts of chemicals, water and steam
used.
Spray balls have different spraying patterns. In addition, there are different
sizes that are available to ensure the spray pattern is sufficient to cover the
walls. Pressure at the spray ball must be sufficient to reach the wall, typically
1.5 to 3 bars. It is important to note that in certain cleaning applications, a
rotating spray device may still be required.
The spray balls are related to the horizontal sizes of tanks more than tank
volumes. This area defines the amount of spray balls, the model and the flow
required. As a general rule, the spray ball must ensure a thin cleaning solution
film, around 2-3 mm in all the walls. This thin cleaning solution film, running
down by the walls will create the required mechanical effect to remove the dirt.
If the flow is too strong, the spray ball will not go through the cleaning solution
at the tank walls, but will pulverize the cleaning solution and the tank without
any cleaning solution effect. The design and amount of spray balls must take
into consideration if there is an agitator, the angles of the paws, and if it is
neck-hanged or foot-supported.
valves are closed. The selection must be in the auto position to start a
cleaning cycle.
3. Run - This selection starts the cleaning cycle for the duration of the
cycle.
4. Cycle bypass - This selection enables cycles to be bypassed. Typically
the supervisor or maintenance personnel use this switch for testing the
programming function.
5. Step number/time remaining - This digital display will show the
operator the step number (e.g., 3-post-rinse) and time remaining (e.g.,
175 seconds) as the system progresses through each cycle.
6. Printer/ Recorder - This unit will be provided to record the return and
feed temperatures, flow rates, supply pressure, temperature, and
conductivity. The unit shall also record the circuit being cleaned, the
time elapsed for each step in the procedure, and the alarm conditions.
Process inputs to the recorder shall be electronic. At a minimum, the
recorder must have electronic display of process signals being monitored
and printed reporting capability. Recorders must have remote capability
for up to 152 meters from the CIP system.
Printed reporting capability shall include, but is not limited to, the
following:
Graphical strip format incorporating alarms, temperature, flow,
pressure and conductivity by time
Chemical usage report
CIP summary report of operating parameters for each executed
program
Report of any alarm conditions that occur during each executed
program
Circuit being cleaned/ sanitized
Elapsed time for the procedure
Date and time for each procedure
7. Alarm Conditions - Alarm conditions will set an audible alarm and
visual alarm light (or display of alarm) when alarm conditions exist (low
water level, timing hold on cycles due to low temperature, high
temperature cutoff, etc.). Hold conditions shall be displayed.
Acknowledgment shall stop an audible alarm and correction of the alarm
condition shall remove the fault and visual display. Additionally, loss of
volume and loss of flow shall cause an alarm condition and an indication
of CIP system fault. The system shall reset to the beginning of the
current step and reset the timer to time zero at correction of fault
condition.
During rinsing and cleaning steps, if the temperature, concentration, or
flow at the return is out of the required minimum specification, the CIP
time measurement must remain on pause until the parameters come
back within the required values. Once the parameters are within the
required specifications, the CIP time measurement can resume from
where it left off.
However, during the sanitation or sterilization step, if temperature,
concentration, or flow at the return are outside of the required minimum
specification, the CIP cycle must be reset to zero, and started from time
zero.
8. Flow Monitoring - CIP flow and velocity monitoring devices shall be
installed at critical CIP circuit positions to enable monitoring to ensure
design performance is achieved and sustained. Critical points include:
CIP returns, filler infeed, CIP feeds as listed on P&ID. Devices shall be
installed per manufacturer instructions on position, distance from
fittings, valves, and equipment. For information on manual velocity
checks, see the Note under item 7 on page 6-18.
Note: In addition to feed and return flow monitoring it is required that
the filler collection CIP return pipe flow (non-intrusive meter and
temperature) be monitored if any portion of the CIP solution bypasses the
filler and returns directly to the CIP system.
In addition to the normal operating controls specified above, the system shall
also have program change capabilities, via password access, for the duration of
any step, the number of steps for cleaning, and the temperature for cleaning.
6.9 Warranties
The guidelines below should be followed to ensure appropriate warranties:
1. Any equipment or parts thereof indicating irremediable or injurious
defects, improper fabrication, excessive repairs, or lack of compliance
with the requirements of this specification shall be subject to rejection.
Any components shall also be subject to rejection if such conditions are
discovered after acceptance at the supplier’s manufacturer’s plant.
2. Any equipment or parts proving defective or failing to meet the
requirements of this specification within 18 months from date of
manufacture completion, shipment, agreed-upon proper storage or 12
months of service shall be replaced free of charge by the manufacturer.
Labor costs associated with such replacements shall also be borne by the
supplier.
3. Equipment shall carry a minimum one-year in-service warranty covering
defective parts, material, workmanship, engineering and performance.
Suppliers shall identify anticipated replacement frequency of the
consumable parts.
4. The supplier shall be responsible for correcting all defects and shortages
in its equipment at the supplier’s cost as necessary to achieve the project
scope performance requirements.
4. To the greatest extent possible, all tanks, equipment, and control panels
shall be skid-mounted, fully assembled, and tested prior to shipment.
Equipment shall be mounted to allow for easy removal and servicing.
Construction of all equipment shall allow adequate clearance (305 mm
minimum) above floor for ease of maintenance and cleaning. An operator
catwalk shall be supplied for safety and to enable access to tank tops/
manholes.
6.14.2 Commissioning
6.14.3 Qualification
6.14.4 Verification
6.15.5 Evaluations
The supplier shall provide outlines of expected learning’s and written tests to
be administered by plant management for all functions and personnel
attending the above training. In addition, the service and training personnel
shall be responsible for providing a formal and confidential evaluation of all
personnel attending the training sessions to the PepsiCo Plant and Project
Managers.
If the existing tanks do not meet all of these criteria, see Item 13 in Section
6.17.5 Required Action Items. In addition, the following items should be
considered:
Yes No
1. Is the detergent concentration in CIP tank controlled by
conductivity and not by titration?
2. Is the concentration of detergents determined before every
CIP?
3. Is there a conductivity sensor on the external heat exchanger
circuit of the alkali and acid tank?
4. Is there a level sensor system on the CIP tanks?
5. Are the bottoms of the CIP tanks conical in shape?
Part 2-CIP Tanks (cont’d)
6. Is there a drain valve at the bottom of each CIP tank?
7. Is the CIP solution during CIP taken from a point above the
drain?
8. Is there a vortex breaker in each CIP tank?
6.18 References
International Society of Beverage Technologists (ISBT) Sanitation Manual,
2005
Ecolab, Making the Right Choice, Cleaners, 2003
Ecolab, Making the Right Choice, Clean in Place (CIP) Systems, 2003
Food Plant Sanitation, Hui, Y.H.; et al 2003
All PepsiCo CIP protocols require that Final Rinse Applications use Treated
Water. The exception is Bottled Water in which product water is to be used. For
specific CIP requirements, see 7.2.2 PepsiCo Beverage Sanitation CIP Protocols.
Important Note: The following CIP cleaning guidelines (from 7.2.2.1 - 7.2.2.24)
are just guidelines, and additional cleaning modifications may be required at
different plants. Individual plants shall document and validate their cleaning
CIP and SSOP procedures. All SSOPs shall be included in the documentation
following the 7 Key Activities of Wet Sanitation.
HA non-ESL/ESL 5-Step CIP (Alkaline Detergent & Steam or High Temp Water Sanitize)
HF HA Dairy 7-Step Chemical CIP (Alkaline and Acid Detergent) and Hot Water Sanitize
LA Aseptic Tank 7-Step CIP/SIP (Acid & Alkaline Detergent & Culinary Steam Sterilize)
HA Ultra-Clean 5-Step CIP (Alkaline Detergent & Steam or High Temp Water Sanitize)
LA ESL Bottle 5-Step CIP (Alkaline Detergent & Steam or High Temp Water Sanitize)
7-Step Hot CIP Acid + Alkaline & Hot Water Sanitize Post Prod. Calcium/Tea Solid Cleaning
HA Aseptic Bottle Filler 5-Step Hot CIP/SIP (Alkaline Detergent & Water Sterilize)
HA Aseptic Carton Filler 5-Step CIP/SIP (Alkaline Detergent & Water Sterilize)
LA Carton Filler 6-Step CIP/SIP (Acid & Alkaline Detergent & Water Sterilize)
LA Bottle Filler 7-Step CIP/SIP (Acid & Alkaline Detergent & Water Sterilize)
3-Step Cold CIP (Common Cleaning and Sanitizing Step/Pungent Rinse )
Bottled Water 3-Step Hot CIP (Alkaline Detergent & Hot Water Sanitize)
Bottled Water 5-Step Hot CIP (Alkaline Detergent & Hot Water Sanitize)
LA UHT 6-Step CIP/SIP (Acid & Alkaline Detergent & Water Sterilize)
HA Aseptic 5-Step CIP/SIP (Alkaline Detergent & Water Sterilize)
5-Step Cold CIP (Alkaline or Acid Detergent & Chemical Sanitize)
5-Step Hot CIP (Alkaline or Acid Detergent & Hot Water Sanitize)
* Approval is required by Corporate/ Global Sanitation/ Quality Manager for changes to Lipton or Sobe CIP procedures; CIP circuit verification and qualification are required prior to approval.
*Approval is required by Corporate/Global Sanitation/Quality Manager for changes to Lipton or Sobe CIP procedures; CIP circuit verification & qualification are required prior to approval.
Version 5 April 2019 Page 7-6 of 36
PepsiCo Beverage Sanitation Manual Chapter 7: Sanitation Protocols
7.2.2.1 A. 5-Step Hot CIP – Alkaline or Acid Detergent and Hot Water Sanitize
Step Procedure Compound* Minimum Minimum Objective/Comment
Temperature* Time*
1. Pre-Rinse Rinse the soil to the drain by pumping Treated or Ambient or ramp up to 5 - 10 min, visually Remove beverage and loose soil.
treated or potable water through the Potable Water detergent temperature clear effluent or Longer times may be needed
system at ambient temperatures or conductivity near depending on pipe length,
ramping up to detergent temperature. treated water or concentration of soil.
potable water. Higher temperatures of
50 – 65°C are recommended for
juice-containing products
2. Clean Clean with an approved alkaline Approved Alkaline detergent: 20 min generic Remove residue.
For organic detergent cleaner or an equivalent formulated 50 – 70°C caustic
soils, use formulated detergent at the supplier’s detergent as per Acid detergent: 10 min (or as Using formulated detergent,
an alkaline recommended concentration and supplier ambient recommended for shorter contact time of
formulated temperature. Pump the cleaner through recommendation. formulated detergent 10 min is possible. However,
detergent. all the process equipment at a rate of For alkaline by supplier) when using generic caustic, time
1.5 m/sec for a minimum of 10 min. detergent, is 20 min.
For mineral Concentration and minimum concentration
or tea soils, temperature must be as per table or the (where not
use an acid manufacturer’s recommendation. available), use For higher levels of juices, higher
detergent. caustic alkaline detergent temperature
Clean with formulated acidic detergent
at the supplier’s recommended 1.5% - 2.0%. and time may be required.
concentration and temperature. Pump
the cleaner through all the process
equipment at a rate of 1.5 m/sec.
3. Intermediate Rinse with treated or potable water to Treated or Preferably at 5 - 10 min, visually Remove cleaner.
Rinse remove the detergent. Test the rinse water Potable Water temperatures listed in clear effluent or
to verify that you have removed all the Step 2 so as not to conductivity near
detergent. waste time heating treated water or
equipment in Step 4. potable water.
4. Sanitize Sanitize with hot treated or potable water. Hot Treated or 85°C 15 min Sanitize equipment.
Keep the minimum equipment surface Potable Water
temperature at 85°C for consecutive 15
min. Verify the temperature on external
equipment surfaces.
5. Final Rinse Rinse with treated water. Treated Water is 25 – 45°C 5 - 10 min Required to cool the equipment to
required safe handling/operating temps.
* Depending on the type of chemicals used and the supplier, the temperature and concentration may vary. Supplier specifications and recommendations shall be followed.
Higher temperatures of
50°C – 65°C are
recommended for juice-
containing products.
2. Clean Clean and Sanitize with an Approved 85°C 15 min Remove residue and
approved formulated alkaline Alkaline Sanitize equipment.
detergent cleaner. Pump the cleaner Detergent from
through all the process equipment - Diversey
at a rate of 1.5 m/sec for a - Ecolab
minimum of 15 min. Concentration
- See Approved
and minimum temperature must be
chemistry list for
as per table or the manufacturer’s
specifics
recommendation and verified on the
external surface of the equipment.
3. Final Rinse with treated water to remove Treated Water is Ambient until 5 - 15 min Rinse equipment to remove
Rinse the detergent. Test the rinse water required equipment is detergent and cool
with appropriate indicator to verify tempered down to equipment to safe
absence of detergent by using safe handling handling/ operating
phenolphthalein or other pH test. temperatures or temperatures (if necessary).
operating
temperature
7.2.2.3 C. 5-Step Cold CIP – Alkaline or Acid Detergent and Chemical Sanitize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Treated or Ambient or ramp up 5 - 10 min, Remove beverage and loose soil.
treated or potable water through the Potable Water to detergent visually clear Longer times may be needed
system at ambient temperatures or temperature effluent or depending on pipe length,
ramping up to detergent temperature. conductivity near concentration of soil.
treated water or
potable water. Higher temperatures of
50 – 65°C are recommended for
juice-containing products.
2. Clean Clean with an approved alkaline Approved Alkaline detergent: 20 min generic Remove residue.
detergent cleaner or an equivalent formulated 50 – 70°C caustic
For organic Using formulated detergent,
formulated detergent at the detergent as per Acid detergent: 10 min (or as shorter contact time of 10 min is
soils, use supplier
supplier’s recommended ambient recommended for possible. However, when using
an alkaline recommendation.
formulated concentration and temperature. formulated generic caustic, time is 20 min.
Pump the cleaner through all the For alkaline detergent by
detergent. detergent, For higher levels of juices,
process equipment at a rate of supplier)
For mineral 1.5 m/sec for a minimum of 10 min. concentration higher alkaline temperature and
or tea soils, Concentration and minimum (where not time may be required.
use an acid temperature must be as per table or available), use
detergent. the manufacturer’s recommendation. caustic
1.5% - 2.0%.
Clean with formulated acidic
detergent at the supplier’s
recommended concentration and
temperature. Pump the cleaner
through all the process equipment at
a rate of 1.5 m/sec.
3. Intermediate Rinse with treated or potable water to Treated or Preferably at 5 - 10 min, Remove cleaner.
remove the detergent. Test the rinse Potable Water temperatures listed in visually clear
Rinse effluent or
water to verify that you have removed all Step 2 so as not to
the detergent. waste time heating conductivity near
equipment in Step 4. treated water or
potable water.
4. Sanitize Sanitize with an approved /registered Approved/ 25 – 45°C 20 min Sanitize equipment.
sanitizer at the supplier’s recommended registered
concentration and temperature. sanitizer used per
supplier
recommendation
/label claim
5. Final Rinse Rinse with treated water. Verify all Treated Water is 25 – 45°C 5 - 10 min, Required to rinse the equipment
chemical sanitizer has been removed by required visually clear until all traces of sanitizer have
testing water clarity and aroma. (Note: effluent or been removed.
Any specific local regulations for rinsing conductivity near
internal areas should be followed.) treated water or
potable water.
7.2.2.4 D. 3-Step Cold CIP – Common Cleaning and Sanitizing Step/Pungent Rinse
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by Treated or Ambient or ramp 5 – 10 min, Remove beverage and loose
pumping treated or potable water Potable Water up to detergent visually clear soil. Longer times may be
through the system at ambient temperature effluent or needed depending on pipe
temperatures or ramping up to conductivity near length, concentration of
detergent temperature. treated water or soil.
potable water.
2. Clean/ Clean and Sanitize with an Approved Acid Ambient 20 min Remove residue and
Sanitize approved formulated acid detergent Detergent sanitize equipment.
cleaner or acid sanitizer. Pump the Or
solution through all the process
equipment at a rate of Approved Acid
1.5 m/sec. Concentration and Sanitizer
minimum temperature must be
per the manufacturer’s
recommendation.
3. Final Rinse Rinse with treated water to remove Treated Water is Ambient 5 – 10 min, Rinse equipment to remove
the detergent/ sanitizer. Test the required visually clear detergent/ sanitizer.
rinse water with appropriate effluent or
indicator to verify absence of conductivity near
detergent/ sanitizer. treated water or
potable water.
2. Clean Clean with an approved Approved Alkaline detergent: 20 min generic Remove residue.
alkaline detergent cleaner or 50 – 70°C
formulated caustic
For organic Acid detergent: Using formulated detergent,
an equivalent formulated detergent as per
soils, use ambient 10 min (or as shorter contact time of
detergent at the supplier’s supplier
an alkaline recommended for 10 min is possible.
recommended concentration
formulated recommendation.
and temperature. Pump the formulated However, when using
detergent. For alkaline
cleaner through all the detergent by generic caustic, time is 20
For mineral process equipment at a rate detergent,
or tea soils, supplier) min.
of 1.5 m/sec for a minimum concentration
use an acid of 10 min. Concentration and (where not For higher levels of juices,
detergent. minimum temperature must higher alkaline temperature
available), use
be as per table or the caustic and time may be required.
manufacturer’s
1.5% - 2.0%.
recommendation.
Clean with formulated acidic
detergent at the supplier’s
recommended concentration
and temperature. Pump the
cleaner through all the
process equipment at a rate
of 1.5 m/sec.
3. Final Rinse Rinse with treated water to Treated Water is Ambient 5 - 10 min, Remove cleaner.
remove the detergent. Test the required visually clear
rinse water to verify that you effluent or
have removed all the detergent. conductivity near
treated water or
potable water.
2. Clean Clean with the generated cleaning Generated Ambient Per vendor Remove residue.
solution at the vendor’s recommended cleaning solution recommendation
concentration. Pump the cleaner per vendor
through all the process equipment at recommendation
a rate of 1.5 m/sec.
3. Sanitize Sanitize with generated sanitizing Generated Ambient Per vendor Sanitize equipment.
solution per vendor recommendation. sanitizing solution recommendation
per vendor
recommendation
4. Final Rinse Rinse with treated water. Test the Treated Water is Ambient 5 - 10 min, visually Required to remove sanitizer.
rinse water to verify that you have required clear effluent or
removed all the sanitizer. (Note: Any conductivity near
specific local regulations for rinsing treated water or
internal areas should be followed.) potable water.
7.2.2.7 G. Hot Fill High-Acid Dairy - 7-Step Chemical CIP – Alkaline and Acid Detergent
Cleaning and Hot Water Sanitize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Warm Treated or 60 – 70°C preferred 5 - 10 min, visually Remove beverage and loose
warm 60 – 70°C treated or potable Potable Water clear effluent or soil.
water through the system. conductivity near
treated water or
potable water.
2. Clean Clean with NaOH at 2.5% or with an Approved 75 – 80°C 30 min Remove residue.
equivalent approved formulated formulated
detergent at the supplier’s detergent as per
recommended concentration and supplier
temperature. Pump the cleaner through recommended
all the process equipment at a rate of Concentration
1.5 m/sec for a minimum of 30 min. (where not
Concentration and minimum available, use
temperature must be as per table or the NaOH at 2.5%)
manufacturer’s recommendation.
3. Intermediate Rinse with hot treated or potable water Hot Treated or 60 – 70°C 5 - 10 min, visually Remove cleaner.
Rinse to remove the detergent. Test the rinse Potable Water clear effluent or
water to verify that you have removed conductivity near
all the caustic. treated water or
potable water.
4. Acid Wash Wash with Nitric Acid at 2.0 % Nitric Acid at 70°C 30 min Remove mineral deposits.
Concentration and 70 °C or an 2.0 % or an
equivalent approved formulated equivalent
sanitizer at the supplier’s recommended approved
concentration and temperature. formulated acidic
cleaner
5. Intermediate Rinse with hot treated water. Hot Treated Water 60 – 70°C 5 - 10 min, visually Required to remove acid wash.
Rinse is required clear effluent or
conductivity near
treated water or
potable water.
6. Sanitize Sanitize with hot treated or potable Hot Treated or 85°C 15 min Sanitize equipment.
7. Final Rinse Rinse with treated water. Treated Water is 25 – 45°C 5 - 10 min Required to cool the equipment
required to safe handling/operating
temps.
Important Note: After CIP, check for absence of milk allergen using Neogen test kit Reveal for Total Milk Allergen.
For the pasteurizer, continuously measure the rise in heating media temperature. Schedule Intermediate CIP when the temperature of the heating media rises more than 5°C (@ > 0.5 °C/
hour) OR 8 °C (@ < 0.5 °C/ hour). Otherwise, schedule CIP once in 24 hours. Intermediate CIP will have shorter times (10-15 minutes) for step number 2 and step number 4 to bring down
the approach temperature. This is a new product/ process for PepsiCo which contains a low percentage of dairy in a juice drink. The CIP program provided is intended to be a starting
place for the respective facility producing this product. The CIP program was demonstrated to be effective for cleaning and sanitizing in current facilities, however, new facilities that are
implementing this CIP program must independently validate that the program is effective.
7.2.2.8 H. High-Acid Aseptic - 5-Step CIP/SIP – Alkaline Detergent and Water Sterilize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by Treated or Ambient or ramp up 5 - 10 min, visually Remove beverage and loose soil.
pumping treated or potable water Potable Water to detergent clear effluent or Longer times may be needed
through the system at ambient temperature conductivity near depending on pipe length,
temperatures or ramping up to treated water or concentration of soil.
detergent temperature. potable water.
Higher temperatures of 50 – 65°C
are recommended for juice
containing products
2. Clean Clean with an approved alkaline Approved 50 – 70°C 20 min generic Remove residue.
detergent cleaner or an formulated caustic Using formulated detergent,
equivalent formulated detergent detergent as per
10 min (or as shorter contact time of 10 min is
at the supplier’s recommended supplier recommended for possible. However, when using
concentration and temperature. recommended formulated generic caustic, time is 20 min.
Pump the cleaner through all the Concentration detergent by
process equipment at a rate of (where not For higher levels of juices, higher
supplier)
1.5 m/sec for a minimum of 10 available, use temperature and time may be
min. Concentration and Caustic 1.5% - required.
minimum temperature must be 2.0%)
as per table or the
manufacturer’s recommendation.
3. Intermediate Rinse with treated or potable Treated or Preferably at 5 - 10 min, visually Remove cleaner.
water to remove the detergent. Potable Water temperatures listed in clear effluent or
Rinse conductivity near
Test the rinse water to verify that Step 2 so as not to
you have removed all the waste time heating treated water or
detergent. equipment in Step 4. potable water.
4. Sterilize Sterilize with hot treated or Hot Treated or 125°C 20 min Sterilize equipment.
potable water. Temperature is Potable Water
verified on the external surface of
the equipment.
5. Final Rinse Rinse with sterilized water Sterilized Water 25°C Approximately 5 - 10 min To cool down the filler to filling
temperature.
Important Note: An additional acid cleaning step may be required (followed by rinsing) before the alkaline cleaning step in cases where the CIP follows a calcium-
added juice or tea product. Food-grade phosphoric, nitric, or citric acid is used at a concentration of 0.5%–2.0% at 55 – 65°C for approximately 10 minutes.
7.2.2.9 I. High-Acid Aseptic Carton Filler - 5-Step CIP/SIP – Alkaline Detergent and Water
Sterilize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Treated or Ambient or ramp up 5 - 10 min, visually Remove beverage and loose soil.
treated or potable water through the Potable Water to detergent clear effluent or Longer times may be needed
system at ambient temperatures or temperature conductivity near depending on pipe length,
ramping up to detergent temperature. treated water or concentration of soil.
potable water.
Higher temperatures of 50 – 65°C
are recommended for juice
containing products
2. Clean Clean with an approved alkaline Approved 50 – 70°C 20 min generic Remove residue.
detergent cleaner or an equivalent formulated caustic Using formulated detergent,
formulated detergent at the supplier’s detergent as per 10 min (or as shorter contact time of 10 min is
recommended concentration and supplier recommended for possible. However, when using
temperature. Pump the cleaner recommended formulated generic caustic, time is 20 min.
through all the process equipment at Concentration detergent by For higher levels of juices, higher
a rate of 1.5 m/sec for a minimum of (where not supplier) temperature and time may be
10 min. Concentration and minimum available, use
required.
temperature must be as per table or Caustic 1.5% -
the manufacturer’s recommendation. 2.0%)
3. Intermediate Rinse with treated or potable water to Treated or Preferably at 5 - 10 min, visually Remove cleaner.
remove the detergent. Test the rinse Potable Water temperatures listed in clear effluent or
Rinse
water to verify that you have removed Step 2 so as not to conductivity near
all the detergent. waste time heating treated water or
equipment in Step 4. potable water.
4. Sterilize Sterilize with hot treated or potable Hot Treated or 125°C for filler 20 min for filler Sterilize equipment.
water. Temperature is verified on the Potable Water
external surface of the equipment.
5. Final Rinse Rinse with sterilized water. Sterilized Water 25°C (Approximately) 5 - 10 min To cool down the filler to filling
temperature.
Important Note: An additional acid cleaning step may be required (followed by rinsing) before the alkaline cleaning step in cases where the CIP follows a calcium-
added juice or tea product. Food-grade phosphoric, nitric, or citric acid is used at a concentration of 0.5%–2.0% at 55–65°C for approximately 10 minutes.
Consult the Processing Authority (PA) for bottle, cap, and machine sterilization. Additionally, follow the equipment vendor recommendations because equipment
performance is dependent on operating as per the vendor’s recommendations.
7.2.2.10 J. High-Acid Aseptic Bottle Filler - 5-Step CIP/SIP – Alkaline Detergent and Water
Sterilize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Treated or Potable Ambient or ramp up 5 - 10 min, visually Remove beverage and loose
treated or potable water through the Water to detergent clear effluent or soil. Longer times may be
system at ambient temperatures or temperature conductivity near needed depending on pipe
ramping up to detergent temperature. treated water or length, concentration of soil.
potable water.
Higher temperatures of 50 –
65°C are recommended for
juice containing products
2. Clean Clean with an approved alkaline Approved 75 - 85°C 20 min generic Remove residue.
detergent cleaner or an equivalent formulated caustic Using formulated detergent,
formulated detergent at the supplier’s detergent as per 10 min (or as shorter contact time of 10 min
recommended concentration and supplier recommended for is possible. However, when
temperature. Pump the cleaner through recommended formulated detergent using generic caustic time is 20
all the process equipment at a rate of Concentration
by supplier) min.
1.5 m/sec for a minimum of 10 min. (where not
Concentration and minimum available, use For higher levels of juices,
temperature must be as per table or the Caustic 1.5% - higher temperature and time
manufacturer’s recommendation. 2.0%) may be required.
3. Intermediate Rinse with treated or potable water to Treated or Potable Preferably at 5 - 10 min, visually Remove cleaner.
remove the detergent. Test the rinse Water temperatures listed clear effluent or
Rinse conductivity near
water to verify that you have removed in Step 2 so as not
all the detergent. to waste time treated water or
heating equipment potable water.
in Step 4.
5. Final Rinse Rinse with sterilized water. Sterilized Water 25 °C 5 - 10 min To cool down the filler to filling
(Approximately) temperature.
Important Note: An additional acid cleaning step may be required (followed by rinsing) before the alkaline cleaning step in cases where the CIP follows a calcium-
added juice or tea product. Food-grade phosphoric, nitric, or citric acid is used at a concentration of 0.5%–2.0% at 55–65°C for approximately 10 minutes.
The filler internal sterilization is done with steam but the other machine parts in the filler block (e.g. Microbiological Isolator) are sterilized with chemicals (e.g. PAA,
Oxonia, etc.) followed by rinsing with sterile water as per the Aseptic Bottle Filler supplier specifications.
Consult PA for bottle, cap, and machine sterilization. Additionally, follow the equipment vendor recommendations because equipment performance is dependent on
operating as per the vendors recommendations.
3. Intermediate Rinse with hot treated or potable water Hot Treated or 65 – 75°C 5 – 10 min, visually Remove cleaner.
to remove the detergent. Test the rinse Potable Water clear effluent or
Rinse conductivity near
water to verify that you have removed
all the caustic. treated water or
potable water.
4. Clean Clean with Nitric/ Citric Acid 1 – 2% or Nitric/ Citric Acid 65 – 75°C 20 – 30 min Remove mineral deposits.
an equivalent approved formulated at 1-2 % or an
acidic detergent at the supplier’s equivalent
recommended concentration and approved
temperature. Pump the cleaner through formulated acidic
all the process equipment at a rate of detergent
1.5 m/sec.
5. Final Rinse Rinse with treated water. Treated Water 25 – 50°C 5 – 10 min Required to remove acid.
Note: Sprayball size, location, and design are critical for tank cleaning. Q = 200 liters/minute x ((Pi x D2)/4) for vertical tanks and Q = 300 liters/minute x ((Pi x
D2)/4) for horizontal tanks where D is the tank diameter. The number of spray balls must be defined by a company specialized at this matter. The pressure
requirement for rotary sprayballs is different than the requirement for non-rotary spray balls.
Acid first (before alkali step) generally works better when UHT is handling high temperatures (greater than 125°C and high levels of protein), whereas alkali first
(before the acid step) generally works better for lower temperatures and lower levels of proteins. Validate the CIP and SIP protocols for new types of low-acid
products.
7.2.2.12 L. Low-Acid UHT - 6-Step CIP/SIP – Acid and Alkaline Detergent and Water Sterilize
All low-acid processes are unique and need to be validated per product per process (each process needs to be evaluated independently); the below protocol is just a
guideline.
2. Clean Clean with Nitric Acid 1 – 2% or an equivalent Nitric Acid at 1-2 % or 65 – 75°C 20 – 30 min Remove mineral deposits.
approved formulated acidic detergent at the an equivalent approved
supplier’s recommended concentration and formulated acidic
temperature. Pump the cleaner through all the detergent
process equipment at a rate of 1.5 m/sec.
3. Intermediate Rinse with hot treated or potable water to Hot Treated or Potable 65 – 75°C 5 – 10 min, Remove acid.
remove the acid. Test the pH of the rinse water Water visually clear
Rinse
to verify all of the acid is removed. effluent or
conductivity
near treated
water or
potable water.
4. Clean Clean with NaOH at 2.0 – 2.5% or an Approved formulated 70 – 80°C 20 – 30 min Clean surface.
equivalent approved formulated alkali detergent detergent as per
at the supplier’s recommended concentration supplier recommended
and temperature. Pump the cleaner through all Concentration (where
the process equipment at a rate of 1.5 m/sec. not available, use
Caustic 2.0% - 2.5%)
5. Post-Rinse Rinse with hot treated or potable water. Hot Treated or Potable 85°C 5 - 10 min Required to remove
Water alkali.
6. Sterilization Hot treated water Hot Treated Water 121.1°C 30 min Sterilize product contact
surfaces. Measured at
return line.
Normally AIC is not carried out with acid. This is because the aggressive nature of the acid at these elevated temperatures will affect the plant’s equipment.
Acid first (before alkali step) generally works better when UHT is handling high temperatures (greater than 125 °C and high levels of protein), whereas alkali first
(before the acid step) generally works better for lower temperatures and lower levels of proteins. Validate the CIP and SIP protocols for new types of low-acid
products. The CIP station for UHT equipment shall not be the same that for raw side.
7.2.2.13 M. Low-Acid Aseptic Tank - 7-Step CIP/SIP – Alkaline and Acid Detergent and
Culinary Steam Sterilize
All low-acid processes are unique and need to be validated per product per process (each process needs to be evaluated independently); the below protocol is just a
guideline.
3. Intermediate Rinse with hot treated or potable water to remove the Hot Treated or Potable 65 – 75°C 5 – 10 min, Remove cleaner.
detergent. Test the rinse water to verify that you have Water visually clear
Rinse effluent or
removed all the caustic.
conductivity
near treated
water or potable
water.
4. Clean Clean with Nitric/ Citric Acid 1 – 2% or an equivalent Nitric/ Citric Acid at 70 – 80°C 20 – 30 min Remove mineral deposits.
approved formulated acidic detergent at the 1-2 % or an equivalent
supplier’s recommended concentration and approved formulated
temperature. Pump the cleaner through all the acidic detergent
process equipment at a rate of 1.5 m/sec.
5. Post-Rinse Rinse with treated or potable water. Treated or Potable Water 25 – 50°C 5 – 10 min, Required to remove acid.
visually clear
effluent or
conductivity
near treated
water or potable
water.
6. Sterilization Culinary Steam Culinary steam 121.1°C 30 min Sterilize product contact
surfaces. Measured at
return line.
7. Cooldown Cooldown equipment with sterile water or a jacketed Sterile Water is required < 25°C (Approximately) Sufficient time To cool down the aseptic
tank with chilled water circulation or combination of to cool down tank to ambient
both. equipment temperature.
- For aseptic tanks, the CIP circuit should be separate from that of the UHT or any "raw side" so as not to contaminate the "aseptic system." Acid first (before the
alkali step) has been found to be more effective in removing some product soils. Validate the CIP and SIP protocols for new types of low-acid products.
7.2.2.14 N. Low-Acid Carton Filler 6-Step CIP/SIP– Alkaline and Acid Detergent and Water
Sterilize
All low-acid processes are unique and need to be validated per product per process (each process needs to be evaluated independently); the below protocol is just a
guideline.
3. Intermediate Rinse with hot treated or potable water Hot Treated or 70 – 80°C 5 min, visually clear Remove alkali.
to remove the alkali. Test the rinse Potable Water effluent or
Rinse conductivity near
water to verify that you have removed
all the alkali. treated water or
potable water.
4. Clean Clean with formulated acidic detergent Pascal at 1-2 % or 70 – 80°C 20 – 30 min Remove mineral deposits.
Pascal 1 – 2 % or an equivalent an equivalent
approved formulated acidic detergent at approved
the supplier’s recommended formulated acidic
concentration and temperature. Pump detergent
the cleaner through all the process
equipment at a rate of 1.5 m/sec.
5. Post-Rinse Rinse with warm treated or potable Warm Treated or 50 – 65°C 5 - 10 min, visually Required to remove acid.
water. Potable Water clear effluent or
conductivity near
treated water or
potable water.
6. Sterilization Hot Water Treated Water 121.1°C 30 min Sterilize product contact
surfaces.
Note: Acid first (before the alkali step) has been found to be more effective in removing some product soils. Validate the CIP and SIP protocols for new types of low-
acid products.
7.2.2.15 O. Low-Acid Bottle Filler 7-Step CIP/SIP – Alkaline and Acid Detergent and Water
Sterilize
All low-acid processes are unique and need to be validated per product per process (each process needs to be evaluated independently); the above
is just a guideline.
2. Clean Clean with formulated alkaline detergent SU 159 at SU 159 at 4 - 6% or an 80°C CIP Intermediate: Clean surface.
4 - 6 % or an equivalent approved formulated alkali equivalent approved 20 min *
detergent at the supplier’s recommended formulated alkali CIP Full: 30 min *
concentration and temperature. Pump the cleaner detergent
through all the process equipment at a rate of
1.5 m/sec for a minimum of 20 min. Concentration
and minimum temperature must be as per table or
the manufacturer’s recommendation.
3. Post-Rinse Rinse with hot treated or potable water to remove Hot Treated or Potable 80°C 5 min, visually Remove alkali.
the alkali. Test the rinse water to verify that you Water clear effluent or
have removed all the alkali. conductivity near
treated water or
potable water.
4. Clean Clean with formulated acidic detergent Pascal Pascal at 1-2 % or an 70 – 80°C CIP Intermediate: Remove mineral deposits.
1 – 2 % or an equivalent approved formulated acidic equivalent approved 20 min *
detergent at the supplier’s recommended formulated acidic CIP Full: 30 min *
concentration and temperature. Pump the cleaner detergent
through all the process equipment at a rate of
1.5 m/sec for a minimum of 20 min. Concentration
and minimum temperature must be per table or
manufacturer recommendation.
5. Post-Rinse Rinse with treated or potable water. Treated or Potable 50°C 5 - 10 min, Required to remove acid.
Water visually clear
effluent or
conductivity near
treated water or
potable water.
6. Sterilization Hot Water Treated Water 121.1°C 30 min Sterilize product contact
surfaces. Measured at return
line.
7. Cooldown Cool Down equipment with sterile water or a Sterile Water is required < 25°C (Approximately) Sufficient time to To cool down the filler to
jacketed tank with chilled water circulation or a cool down ambient temperature.
combination of both. equipment
* The minimum wash time depends on the composition of and the ingredients in the beverage. The minimum wash times provided are based on CIP protocols for existing
products. Acid first (before the alkali step) has been found to be more effective in removing some product soils.. Validate the CIP and SIP protocols for new types of low-acid
products.
7.2.2.16 P. Bottled Water 3-Step Hot CIP – Alkaline Detergent and Hot Water Sanitize
Refer to the PepsiCo Bottled Water Technical Reference Manual for additional CIP details.
2. Clean Clean and Sanitize with an approved Alkaline Detergent 85°C 15 min Remove residue and Sanitize
alkaline detergent cleaner. Pump the 3000 – 5000 ppm equipment.
cleaner through all the process Contact Global
equipment at a rate of 1.5 m/sec for a Sanitation
minimum of 15 min. Concentration and Authority for
minimum temperature must be as per approved
table or the manufacturer’s chemistry
recommendation. Verify the temperature
on external equipment surfaces.
3. Rinse Rinse with product water to remove the Product water for Ambient until 5 - 15 min Rinse equipment to remove
detergent. Test the rinse water with natural mineral equipment is detergent and cool the
phenolphthalein to verify that you have water and tempered down to equipment to safe handling
removed all the caustic. deozonated safe handling temperature.
product water for temperatures
purified and
processed water
7.2.2.17 Q. Bottled Water 5-Step Hot CIP – Alkaline Detergent and Hot Water Sanitize
Refer to the PepsiCo Bottled Water Technical Reference Manual for additional CIP details.
2. Clean Clean with an approved alkaline Alkaline Detergent 50 - 60°C 10 – 15 min Remove residue.
detergent cleaner. Pump the cleaner
through all the process equipment at a
rate of 1.5 m/sec for a minimum of 10 -
15 min. Concentration and minimum
temperature must be as per table or the
manufacturer’s recommendation. Verify
the temperature on external equipment
surfaces.
3. Rinse Rinse with water to remove the Treated or Potable Ambient to ramp up 5 - 10 min, visually Rinse equipment to remove
detergent. Test the rinse water to verify Water for hot water clear effluent or detergent.
that you have removed all the caustic. sanitize conductivity near
(RO Water for treated water or
Purified Water) potable water.
4. Sanitize Sanitize with hot water. Verify the Hot Treated or 85°C 15 min Sanitize equipment.
temperature on external equipment Potable Water
surfaces.
(RO Water for
Purified Water)
5. Final Rinse Rinse with product water. Product water for Ambient until 15 min Rinse until equipment is
Use product water for natural mineral natural mineral equipment is tempered down to safe
water water and tempered down to handling temperature.
deozonated safe handling
Use deozonated product water for product water for temperatures
purified and processed water purified and
processed water
7.2.2.18 R. 7-Step Hot CIP – Acid plus Alkaline Detergent and Hot Water Sanitize (Post-
Production Calcium/Tea Solid Cleaning)
Step Procedure Compound Minimum Minimum Objective/ Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping treated or Treated or Potable Water Ambient or ramp up to 5 - 10 min, Remove beverage and loose soil. Longer
potable water through the system at ambient detergent temperature visually clear times may be needed depending on
temperatures or ramping up to detergent temperature. effluent or pipe length, concentration of soil.
conductivity near
Higher temperatures of 50 – 65°C are
treated water or
recommended for juice-containing
potable water.
products.
2. Clean Clean with an approved acid cleaner at the supplier’s Approved formulated acid 50 – 70°C 10 min (or as Remove Calcium scale/ tea solids or
recommended concentration and temperature. Pump cleaner as per supplier recommended by apple juice residue.
the cleaner through all the process equipment at a recommended supplier)
For higher calcium levels of juices,
rate of 1.5 m/sec for a minimum of 10 min. Concentration (where not
higher temperature or time may be
Concentration and minimum temperature must be as available, use Phosphoric,
required.
per table or the manufacturer’s recommendation. Nitric, or Citric acid at 0.5%
to 2.0%)
3. Intermediate Rinse the soil to the drain by pumping treated or Treated or Potable Water Ambient or ramp up to 5 - 10 min, Remove beverage and loose soil. Longer
potable water through the system at ambient detergent temperature visually clear times may be needed depending on
Rinse
temperatures or ramping up to detergent temperature. effluent or pipe length, concentration of soil.
conductivity near
Higher temperatures of 50 – 65°C are
treated water or
recommended for juice-containing
potable water.
products.
4. Clean Clean with an approved alkaline detergent cleaner or Approved formulated 50 – 65°C 20 min generic Remove residue.
an equivalent formulated detergent at the supplier’s detergent as per supplier caustic
Using formulated detergent, shorter
recommended concentration and temperature. Pump recommended
10 min (or as contact time of 10 min is possible.
the cleaner through all the process equipment at a Concentration (where not
recommended for However, when using generic caustic,
rate of 1.5 m/sec for a minimum of 10 min. available, use Caustic 1.5%
formulated time is 20 min.
Concentration and minimum temperature must be as - 2.0%)
detergent by
For higher levels of juices, higher
per table or the manufacturer’s recommendation.
supplier)
temperature and time may be required.
5. Intermediate Rinse with treated or potable water to remove the Treated or Potable Water Preferably at 5 - 10 min, Remove cleaner.
detergent. Test the rinse water to verify that you have temperatures listed in visually clear
Rinse
effluent or
6. Sanitize Sanitize with hot treated or potable water. Keep the Hot Treated or Potable 85°C (as measured by 15 min Sanitize equipment.
minimum equipment surface temperature at 85°C for Water external verification)
consecutive 15 min. Verify the temperature on
external equipment surfaces.
7. Final Rinse Rinse with treated water. Treated Water is required 25 – 45°C 5 - 10 min Required to cool the equipment to
ambient.
* The minimum wash time depends on the composition of and the ingredients in the beverage. The minimum wash times provided are based on CIP protocols for
existing products.
7.2.2.19 S. High-Acid Chilled Distribution non-ESL and ESL - 5-Step CIP – Alkaline Detergent
and Steam or High Temperature Water Sanitize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Treated / Potable Ambient or ramp up to 5 - 10 minutes to Remove beverage and loose soil.
treated or potable water through the system Water detergent temperature visually clear effluent Longer times may be needed
at ambient temperatures or ramping up to or conductivity near depending on pipe length,
detergent temperature. treated water or concentration of soil.
potable water.
Higher temperatures of 50 – 65°C are
recommended for juice containing
products for efficient pre-rinsing.
2. Clean Clean with an approved generic caustic or Approved 50 – 70°C or as 10 min (or as Remove residue.
an approved formulated detergent at the formulated recommended by recommended for
supplier’s recommended concentration and detergent as per supplier formulated detergent
temperature. Pump the cleaner through all supplier by supplier) Based on product and pulp content,
the process equipment at a rate of 1.5 recommended higher temperature and longer contact
m/sec for a minimum of 10 min. concentration. time may be required.
Concentration and minimum temperature 20 min generic caustic
Generic caustic use
must be as per table or the supplier’s
recommendation. 1.5% - 2.0%
3. Intermediate Rinse with treated / potable water to Treated / Potable Ambient or detergent 5 – 10 minutes to Remove cleaner.
remove the detergent. Test the rinse water Water temperature. visually clear effluent
Rinse to verify that you have removed all the or conductivity near
detergent. treated water or
potable water.
4. Sanitize Sanitize with high temperature treated / Treated / Potable 96oC for pipes / 15 mins for pipes / Sanitize equipment.
potable water or culinary steam. Water pasteurizers pasteurizers
Temperature is verified on the external 99oC for pipes / 10 mins for pipes /
surface of the equipment. pasteurizers pasteurizers
104oC for tanks / fillers 30 mins for tanks /
fillers
5. Final Rinse Rinse with sterilized water. Sterilized Water Ambient 5 - 10 min To cool down the filler to filling
temperature.
Important Note: An additional acid cleaning step may be required (followed by rinsing) before the alkaline
cleaning step in cases where the CIP follows a calcium-added juice or tea product. Food-grade phosphoric,
nitric, or citric acid is used at a concentration of 0.5%–2.0% at 55–65°C for approximately 10 minutes.
7.2.2.20 T. Low-Acid Chilled Distribution ESL Bottle - 5-Step CIP – Alkaline Detergent and
Steam or High Temperature Water Sanitize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Treated / Potable Ambient or ramp up to 5 - 10 minutes to Remove beverage and loose soil.
treated or potable water through the system Water detergent temperature visually clear effluent Longer times may be needed
at ambient temperatures or ramping up to or conductivity near depending on pipe length,
detergent temperature. treated water or concentration of soil.
potable water.
Higher temperatures of 50 – 65°C are
recommended for juice containing
products for efficient pre-rinsing.
2. Clean Clean with an approved generic caustic or Approved 50 – 70°C or as 10 min (or as Remove residue.
an approved formulated detergent at the formulated recommended by recommended for
supplier’s recommended concentration and detergent as per supplier. formulated detergent
temperature. Pump the cleaner through all supplier by supplier) Based on product and pulp content,
the process equipment at a rate of 1.5 recommended higher temperature and longer contact
m/sec for a minimum of 10 min. concentration. time may be required.
Concentration and minimum temperature 20 min generic caustic
Generic caustic use
must be as per table or the supplier’s
recommendation. 1.5% - 2.0%
3. Intermediate Rinse with treated / potable water to Treated / Potable Ambient or detergent 5 – 10 minutes to Remove cleaner.
remove the detergent. Test the rinse water Water temperature. visually clear effluent
Rinse to verify that you have removed all the or conductivity near
detergent. treated water or
potable water.
4. Sanitize Sanitize with high temperature treated / Treated / Potable 121.5oC for pipes / 30 mins for pipes / Sanitize equipment.
potable water or culinary steam. Water pasteurizers pasteurizers
Temperature is verified on the external 125oC for pipes / 20 mins for pipes /
surface of the equipment. pasteurizers pasteurizers
5. Final Rinse Rinse with sterilized water. Sterilized Water Ambient 5 - 10 min To cool down the filler to filling
temperature.
Important Note: An additional acid cleaning step may be required (followed by rinsing) before the alkaline
cleaning step in cases where the CIP follows a calcium-added juice or tea product. Food-grade phosphoric,
nitric, or citric acid is used at a concentration of 0.5%–2.0% at 55–65°C for approximately 10 minutes
7.2.2.21 U. High-Acid Chilled Distribution Ultra-Clean Bottle - 5-Step CIP – Alkaline Detergent
and Steam or High Temperature Water Sanitize
Step Procedure Compound Minimum Minimum Objective/Comment
Temperature Time
1. Pre-Rinse Rinse the soil to the drain by pumping Treated / Potable Ambient or ramp up to 5 - 10 minutes to Remove beverage and loose soil.
treated or potable water through the system Water detergent temperature visually clear effluent Longer times may be needed
at ambient temperatures or ramping up to or conductivity near depending on pipe length,
detergent temperature. treated water or concentration of soil.
potable water.
Higher temperatures of 50 – 65°C are
recommended for juice containing
products for efficient pre-rinsing.
2. Clean Clean with an approved generic caustic or Approved 50 – 70°C or as 10 min (or as Remove residue.
an approved formulated detergent at the formulated recommended by recommended for
supplier’s recommended concentration and detergent as per supplier. formulated detergent
temperature. Pump the cleaner through all supplier by supplier) Based on product and pulp content,
the process equipment at a rate of 1.5 recommended higher temperature and longer contact
m/sec for a minimum of 10 min. concentration. time may be required.
Concentration and minimum temperature 20 min generic caustic
Generic caustic use
must be as per table or the supplier’s
recommendation. 1.5% - 2.0%
3. Intermediate Rinse with treated / potable water to Treated / Potable Ambient or detergent 5 – 10 minutes to Remove cleaner.
remove the detergent. Test the rinse water Water temperature. visually clear effluent
Rinse to verify that you have removed all the or conductivity near
detergent. treated water or
potable water.
4. Sanitize Sanitize with high temperature treated / Treated / Potable 104oC for pipes / 15 mins for pipes / Sanitize equipment.
potable water or culinary steam. Water pasteurizers pasteurizers
Temperature is verified on the external
surface of the equipment.
Culinary steam 104oC for fillers 20 mins for fillers
104oC for A-tank 30 mins for A-tank
5. Final Rinse Rinse with sterilized water. Sterilized Water Ambient 5 - 10 min To cool down the filler to filling
temperature.
Important Note: An additional acid cleaning step may be required (followed by rinsing) before the alkaline cleaning step in cases where the CIP follows a calcium-
added juice or tea product. Food-grade phosphoric, nitric, or citric acid is used at a concentration of 0.5%–2.0% at 55–65°C for approximately 10 minutes.
Utilize allergen qualitative test kits to sample specific sights (swabs) and
samples (rinse water). Proceed with allergen verification in a similar fashion as
CIP qualification - testing each circuit one loop at a time from beginning to end.
For allergen cleaning validation, sanitizing chemicals should not be used in the
last cleaning step as they may interfere with allergen test kits.
9.1.1 Labeling
All chemical drums, totes, pails or other containers must be properly
labeled prior to shipment into the plant. Labels must contain
information about health effects, fire and reactivity, first aid and
required personal protective equipment. Employees should be trained
to read and interpret labels before handling any product.
All secondary containers must also be labeled. Never transfer a
chemical from a drum into an unlabeled container.
9.1.3.1 Receiving
Have the proper equipment for handling drums and other large
containers to prevent back and leg injuries.
If chemicals are received in bulk, ensure that bulk receiving and
storage procedures are in place and employees are trained. During
bulk receiving of chemicals, there is a risk of pumping chemicals into
the wrong tank or overfilling tanks. Be sure that all hoses and hook-
ups are properly labeled and that the labels are well maintained.
Pipes must be clearly marked and receiving tanks inspected to ensure
they have sufficient capacity to receive the chemical.
9.1.3.2 Storage
Sanitation chemicals must be stored in a location separate from raw
materials, packaging components, and finished products.
Sanitation chemicals should be stored in a locked area with limited
access.
Store all chemicals in a dry, cool environment. Keep out of sunlight.
If possible store away from production areas.
Segregate incompatible chemicals so, for example, acid is not stored
next to caustic or chlorine.
Storage area should be adequately ventilated. Some chemicals are
volatile and odors may permeate the storage area.
Storage area must be kept neat and orderly.
Ensure all caps are closed tightly to minimize escape of vapors.
Maintain at least 18 inches of clearance from walls and all sprinkler
heads.
9.1.3.3 Transfer
Hand drum pumps are not recommended, since they increase the risk
of spills, personal contact, and cross-contamination. Wherever
possible, install automatic, remote transfer equipment for
concentrates and use dilutions.
All transfer pumps must be clearly labeled. If possible, transfer
pumps should be dedicated to specific materials. Transfer pumps
that were used for processing fluids (oils, grease, etc.) should never be
used for sanitation chemicals.
If chemicals are classified as flammable, ensure appropriate handling
and transfer procedures are in place.
9.1.3.4 Dilution
Always dilute chemicals into water. Never add water into a
concentrated chemical.
Wherever possible, add chemicals to cold or ambient temperature
water. Avoid adding chemicals to hot water; the dilution reaction may
cause “splash back.” The diluted solution can be heated after the
dilution is made.
Slowly add concentrated chemicals to water, to minimize heat
buildup.
Always prepare the recommended concentration. Do not make
solutions that are stronger than recommended – they may lead to
9.1.3.5 Application
Follow all directions for applying chemicals, whether manually, by
spray, foam or CIP.
Manual application – do not clean any equipment which is still
operating. Be sure all “lock out-tag out” procedures are followed. If
entering tanks, check for confined space entry procedures.
Spray and foam application – make sure other personnel are not in
the area that is being sprayed or foamed. Cover all electrical outlets
or sensitive production controls and equipment.
CIP – Make sure all hookups are correct and all tanks are empty and
ready for CIP.
Ensure all lines are flushed immediately after use.
falls.
Always wear safety goggles with side shields.
Always wear shoes with slip-resistant soles.
Boots
Hand protection
Eye and Face protection
If a spill or leak occurs, ensure personnel who are working in the
immediate vicinity are evacuated promptly.
Protect floor drains or other potential avenues of environmental
release as much as possible.
Decontaminate the spill area following the cleanup. Report any spills
to management and if required to the local authorities.
Dispose of all contaminated materials according to the manufacturer's
instructions and the local regulations.
For large spills, outside emergency response personnel (police and fire
department HAZMAT teams) should be contacted.
9.2 References
International Society of Beverage Technologists (ISBT) Sanitation
Manual, 2005
PI Operational Practices Manual – GMP and Sanitation, 2005
Ecolab and Diversey have been previously evaluated by the Global Sanitation
Team and have demonstrated full compliance to these requirements.
1. Does the cleaning and sanitizing chemical supplier have a robust raw
material approval and maintenance process?
2. Does the cleaning and sanitizing chemical supplier require its suppliers
to provide full disclosure of raw materials via a declaration for each
material that is purchased?
The declaration must include:
Chemical/ Ingredient Name
CAS#
% Composition
Material Safety Data Sheet (MSDS)/ European Safety Data Sheet
(SDS)
Chemical/ Ingredient Specification and Certificate of Analysis
Hazard Declarations or Ratings
Toxicity and Biodegradability Data
3. Does the cleaning and sanitizing chemical supplier require its suppliers
to indicate all chemicals/ ingredients known to be banned at the
following concentration levels:
All ingredients present at a concentration of 0.1% or greater in the
material as sold
All chemical impurities in the material at a concentration of 0.01% or
greater (unless a lower concentration limit is specified by the
sanitation chemical supplier or PepsiCo)
4. Does the cleaning and sanitizing chemical supplier conduct a thorough
risk analysis of all raw materials that will be brought into its system?
The following assessments must be conducted:
Regulatory assessment (at either a local or global level)
Assess all raw materials against known lists of chemical
carcinogens and other chemicals known to be banned or have
limited use levels
Confirm approval status and level globally and for the country of
use
Inventory assessment for each country that will be supplied
5. Does the cleaning and sanitizing chemical supplier have raw material
specifications for all raw materials that will be brought into their system?
Does the supplier confirm that their suppliers adhere to the raw material
specifications (via sign-off and ongoing checks)?
10.2.1 Facility Assessment and Trial Protocols for Approval of New Cleaning
and Sanitizing Products, Technologies, and Platforms
Prior to approving new cleaning and sanitizing products, technologies, and platforms,
data must be collected and available to ensure its efficacy. This would include a
thorough investigation of the technology as well as in-depth comparisons with the
existing sanitation program.
When approving new cleaning and sanitizing chemicals, the approval protocol that must
be followed includes a facility assessment as well as completion of a sanitation program
implementation checklist. This information will be used to determine whether the facility
is capable of supporting a trial of the new cleaning or sanitizing chemical.
8. CIP Programming (Bev Prep & Filler or Balance / Supply tanks & Filler):
A. Initial Rinse _____ Time _____ Target Temp _____ Max Temp
B. Wash/Sanitize _____ Time _____ Target Temp _____ Max Temp
C. Wash/Sanitize _____ Chemical Concentration
D. Cooldown _____ Time _____ Temp (at completion)
E. Final Rinse _____ Time _____ CIP Bypassed (Y/N) _____ De-O3 (Y/N)
9. CIP Programming (Bev Prep Only):
A. Initial Rinse _____ Time _____ Target Temp _____ Max Temp
B. Wash/Sanitize _____ Time _____ Target Temp _____ Max Temp
C. Wash/Sanitize _____ Chemical Concentration
D. Cooldown _____ Time _____ Temp (at completion)
E. Final Rinse _____ Time _____ CIP Bypassed (Y/N) _____ De-O3 (Y/N)
10. CIP Programming (Filler Only):
A. Initial Rinse _____ Time _____ Target Temp _____ Max Temp
B. Wash/Sanitize _____ Time _____ Target Temp _____ Max Temp
C. Wash/Sanitize _____ Chemical Concentration
D. Cooldown _____ Time _____ Temp (at completion)
E. Final Rinse _____ Time _____ CIP Bypassed (Y/N) _____ De-O3 (Y/N)
11. CIP Programming (Syrup Tanks or Batch Tanks):
A. Initial Rinse _____ Time _____ Target Temp _____ Max Temp
B. Wash/Sanitize _____ Time _____ Target Temp _____ Max Temp
C. Wash/Sanitize _____ Chemical Concentration
D. Cooldown _____ Time _____ Temp (at completion)
E. Final Rinse _____ Time _____ CIP Bypassed (Y/N) _____ De-O3 (Y/N)
12. Modify PM 30 (Preventive Maintenance program, manual or automated)
system for the following:
A. Quarterly visual inspections in syrup / batch / balance / supply tanks for
chemical buildup, corrosion, and syrup / product residual
B. Quarterly visual inspections on filler valves for chemical buildup, corrosion, and
syrup / product residual
10.3 Trial Protocol for the Evaluation of New Cleaning and Sanitizing Chemicals
In addition to confirming that a facility is capable of supporting a trial,
additional verification from the sanitation chemical supplier is required to
ensure that:
1. The CIP supply water is compatible with the new sanitation chemical.
2. The facilities CIP skid and process are capable of supporting the
requirements of the new sanitation chemical.
3. Adequate programming support can be provided to the facility to support
the trial.
After verification from the sanitation chemical supplier, the plant can begin a
trial; the protocol below must be followed:
Conduct an initial double CIP using the new cleaning and sanitizing
chemical program followed by the current CIP program:
Collect micro data following both CIP’s as per existing program.
Confirm that the new CIP program has comparable results to the
current CIP program.
Ongoing, micro data for yeast, mold, and acid bacteria must be
collected for the next 12 weeks (submitted weekly to Corporate or
designated individual/ function) to validate the new CIP program is
acceptable.
Plant must notify Region/ Sector Quality when first 3-Step Cold CIP will
be performed.
Vendor must analyze the CIP supply water to verify compatibility with
the chemical.
If not already qualified for 3-Step Hot, plant/vendor must complete
“Sanitation Chemical Implementation Checklist” (section 10.2.1.1.1).
Vendor must support programming setup for each location.
Once setup is complete, the plant will perform one 3-step Cold CIP for
the producing line and pull rinse water samples.
Immediately after completion of the 3-Step Cold CIP, a 5-Step Hot or 5-
Step Cold CIP for the producing line will be required also pulling rinse
water samples.
Rinse water results must be provided to Region/ Sector Quality for
review. If rinse water results are comparable to previous 5-Step Hot or 5-
Step Cold CIP micro results and meet category requirements, then the
plant may proceed with using a 3-Step Cold CIP following BU Approval.
Rinse water testing for the 3-Step Cold CIP will be performed as part of
the normal micro process and will be evaluated by the plant.
Syrup Tank Process (3-Step Cold CIP: Cat 1+2)
The validation process will focus on syrup tank sanitations. The below process
will be required for one syrup tank to validate the 3-Step Cold CIP process for
all syrup tanks.
Supplier Chemical
Ecolab (North America and Mexico) Octave (acid sanitizer, single use)
Ecolab (Global) Advantis 210 + Oxonia Active 150
Ecolab (North America, Latin America, and Advantis LT Base/ Activator
Asia Pacific)
Diversey Divosan Plus (acid sanitizer, single use)
Diversey Diverflow OSA-N (acid detergent,
reclaim/reuse)
Vendor must analyze the CIP supply water to verify compatibility with
the chemical.
If not already qualified for 3-Step Hot, plant/vendor must complete
“Sanitation Chemical Implementation Checklist” (section 10.2.1.1.1).
Vendor must support programming setup for each location.
Complete a 3-Step Cold CIP on one syrup tank and perform ATP swab
testing on rinse water and 3 random locations of syrup tank wall.
ATP results must be provided to Region/Sector Quality for review. If
ATP results are comparable to the baseline established for that tank
then the plant may proceed with using a 3-Step Cold CIP following BU
Approval.
Return to current ATP swab sampling plan outlined in the
Microbiological Sampling Plan document.
then the plant may proceed with substituting a 3-Step Cold CIP following
Region/ Sector approval.
The 3-Step Cold CIP can be used for any additional CIPs needed for
the week after the initial 5-Step Hot or approved 3-Step Hot CIP
that begins that week. This will also include filler-only CIPs for
Aquafina. After 7 days, a 5-Step Hot or approved 3-Step Hot CIP
must be performed.
Rinse water testing for the 3-Step Cold CIP will be performed as part of
the normal micro process. Each week the plant will be required to
forward the micro results from all CIPs performed online to Region/
Sector Quality for review and tracking. The plant will be required to
submit weekly reports for 1 month to Region/Sector Quality, and then
proceed with normal submissions.
Syrup Tank Process (3-Step Cold CIP: Cat 3 and Bottled Water)
The validation process will focus on syrup tank sanitations. The below process
will be required for one syrup tank to validate the 3-Step Cold CIP process for
all syrup tanks.
Supplier Chemical
Ecolab (North America and Mexico) Octave (acid sanitizer, single use)
Ecolab (Global) Advantis 210 + Oxonia Active 150
Ecolab (North America, Latin America, and Asia Advantis LT Base/ Activator
Pacific)
Diversey Divosan Plus (acid sanitizer, single use)
Diversey Diverflow OSA-N (acid detergent,
reclaim/reuse)
Vendor must analyze the CIP supply water to verify compatibility with
the chemical.
Vendor must verify CIP skid and process performance unless performed
for the 3-Step Hot qualification.
If not already qualified for 3-Step Hot, vendor must complete “Sanitation
Chemical Implementation Checklist” (section 10.2.1.1.1).
Vendor must support programming setup for each location.
Complete a 3-Step Cold CIP on one syrup tank and perform ATP swab
testing on rinse water and 3 random locations of syrup tank wall.
ATP results must be provided to Region/ Sector Quality for review. If ATP
results are comparable to the baseline established for that tank, then the
plant may proceed with substituting a 3-Step Cold CIP following BU
Approval.
The 3-Step Cold CIP can be used for any additional CIPs needed for
the week after the initial 5-Step Hot or approved 3-Step Hot CIP
that begins that week. This will also include filler-only CIPs for
Plant must notify Region/ Sector Quality when first 3-Step Hot CIP will
be performed.
Vendor must analyze the CIP supply water to verify compatibility with
detergent at elevated temperatures.
Vendor must verify CIP skid and process performance.
Vendor must support programming setup for each location.
Vendor must complete “Sanitation Chemical Implementation Checklist”
(section 10.2.1.1.1).
Once setup is complete, the plant will perform one 3-Step Hot CIP (85°C
Temperature at external shell) for CFP and collect rinse water samples
from 25% of the filler valves.
Immediately after completion of the 3-Step Hot CIP, a 5 Step Hot CIP for
CFP will be done. Again collect rinse water samples from the same 25%
of the filler valves.
If rinse water results are comparable to previous 5-Step Hot CIP micro
results AND meet category A requirements, then the plant may proceed
with substituting a 3-Step Hot CIP in place of current 5-Step Hot CIPs
on that producing line. Same process of validation to be followed for
Aquafina filler CIP.
Rinse water testing for the 3-Step Hot CIP will be performed as part of
the normal micro process. Each week, the plant will be required to
forward the micro results from all CIPs performed online to Region/
Sector Quality for review and tracking. The plant will be required to
submit weekly reports for 1 month, and then proceed with normal
monthly submissions.
Syrup Tank Process (3-Step Hot CIP: Cat 3 and Bottled Water)
The validation process will focus on syrup tank sanitations. The below process
will be required for one syrup tank to validate the 3-Step Hot CIP process for all
syrup tanks of similar design.
Supplier Chemical
Ecolab (North America and Mexico) Advantis 330
Ecolab (Global) Advantis 210
Ecolab (Global) Advantis LT Base
Diversey Divoflow 185
Vendor must analyze the CIP supply water to verify compatibility with
detergent at elevated temperatures.
Vendor must verify CIP skid and process performance.
Vendor must support programming setup for each location.
Vendor must complete 3-Step Hot Implementation Checklist.
Complete a 3-Step Hot CIP (85°C at external shell temperature) on one
syrup tank and perform ATP swab testing/rinse water.
If ATP/rinse/swab results are comparable to the baseline established for
that tank, then proceed with substituting a 3-Step Hot CIP for all your
current 5-Step Hot CIPs on all syrup tanks.
On an ongoing basis, follow the Microbiological Sampling Plan document.
10.5 References
Diversey, Supplier Approval Program, 2009
Ecolab, Supplier Approval Program, 2009
11.1 Background
In PepsiCo Beverage Plants, to ensure the hygienic design, attention must be
given to external and internal surfaces. Surfaces mainly can be subdivided into
two categories:
• Product Contact Surfaces
• Non-Product Contact Surfaces
A food product contact surface is a surface in direct contact with product or
ingredients or their residues. Because these surfaces, if contaminated, can
directly result in product contamination, rigid sanitary design criteria must be
met. Non-product contact surfaces are those that are part of the equipment
(e.g., legs, supports, housings) that do not directly contact products. As
contamination of non-product contact surfaces can cause indirect
contamination of the product, these surfaces cannot be ignored with regard to
sanitary design.
In addition to external and internal surfaces, the following subjects are critical
and will be explained in this Chapter:
• Material selection
• Welding and finishing quality
• Piping Design/ dead legs
• Drain design
• Passivation
made to contain, store and remove or treat reject material generated in the
process.
Any pallet storage area should leave a minimum 18” (450mm) from walls and
14” (350mm) between pallet rows.
Materials must be stored off the floor on pallets or slip sheets, and if racking is
used, then the lowest rack must leave a free space of 18” (450mm) from the
floor.
Adequate space should be allowed for sorting and storage of reject material,
and space should be provided for the removal of any outer protective packaging
on pallets prior to their transfer to the process or packing areas.
Adequate lighting needed to support the work performed in the area, including
inspection, must be provided (luminance of 500 LUX).
All light fittings, bulbs, lamps and tubes shall be protected against falling, and
shall be shatter-resistant, housed in shatter-resistant fixtures or otherwise
protected against breakage.
11.2.3 Internal Surfaces
Internal surfaces should be smooth and constructed so as not to form any
horizontal ledges.
They must use materials which are non-toxic, odorless and resistant to the
normal method of cleaning and cleaning chemicals. Further, they must be
easily cleaned and generally light in color so that any dirt or contaminant can
be easily seen. Where required, the design should ensure the surfaces can
withstand high-pressure hosing.
Finishing material should be in line with PepsiCo recommendation.
Wall and floor junctions shall be designed for easy cleaning – e.g. using a
suitable curved coving.
Where there is a roof void, adequate access must be provided to allow
inspection and cleaning.
11.2.3.1 Internal Surfaces – Wet Production Areas
Floors must be constructed with suitable falls to drain so that no standing
water occurs within the process area.
Avoid condensation in wet production areas.
Floor finishes must be according to required hygiene Level (i.e. acid resistant
tile or epoxy).
11.2.3.2 Internal Surfaces – Dry Production Areas
Powder handling and filling areas must be suitable for washing down, and
therefore, finishes must be to the same standard as wet areas stated above.
For dry production areas which are not normally washed, the surface finish
must still be smooth and resistant to the materials in contact and to the
cleaning method used.
All dry areas must have adequately designed ventilation, and local extraction
facilities where required, to prevent condensation on any surface, odors and
Version 5 April 2019 Page 11-4 of 30
PepsiCo Beverage Sanitation Manual Chapter 11: Hygienic & Sanitary Design
• To the greatest extent possible, all equipment and control panels shall be
skid-mounted, fully assembled, and tested prior to shipment. In addition,
all CIP components shall be of a sanitary design. Equipment shall be
mounted to allow for easy removal and servicing. Construction of all
equipment shall allow adequate clearance (305 mm minimum) above
floor for ease of maintenance and cleaning. An operator catwalk shall be
supplied for safety and to enable access to tank tops/ manholes.
CIP cleaning must provide full coverage; no shadowing from agitators allowed.
Figure 11-1. Spray ball full coverage (left) and covered (right).
11.3.3 Valves
Only Food Grade Sanitary Valves are to be used.
Sanitary valve design must meet 3A, EHEDG or equivalent design.
However, diaphragm valves were not designed specifically for hygienic and
aseptic application, since there can be crevice and/or leak formation risk.
PI
Borescope testing of welds on piping should be done to see the quality of welds.
Borescope is an optical device consisting of a rigid or flexible tube with an
eyepiece on one end, and a lens on the other linked together by an optical
system in between.
Use the correct type of valve to avoid dead areas when diverting flow as in
Figure 11-16.
Figure 11-16. Correct valve type avoids dead areas when diverting flow.
The installation of pressure and temperature transmitters into piping can
introduce dead legs.
Swept Tees may be used with caution and the choice of instrument may also
help if using surface mounted temperature instruments. Figure 11-17 shows
how a temperature sensor may be hygienically installed in a pipe:
• The piping coming from the process must be as short as possible. This
portion of piping must drain naturally by gravity (slope). It is cleaned
only during the pulsation of the valve.
• Waste collection piping must be able to be disassembled and drained;
and must be regularly manually cleaned.
11.7.3 Gaskets
Gaskets for connectors, valves or plate heat exchangers shall be made of EPDM
or Nitrile. The latter material is recommended for products containing fat. On
low-temperature piping and in piping used by concentrated solutions of acid or
alkali, peroxide, or steam, the gaskets shall be made of Viton or PTFE. (Valve
seals for Gatorade product to be Viton.)
The Supplier shall validate and warrant gasket material compatibility under all
usage conditions in this application.
During fabrication and handling, the stainless steel surface becomes damaged
or fouled with foreign matter. To return the stainless steel back to its passive
state (passivation), the chromium oxide film must be restored and foreign
matter must be removed. Passivation procedures are in effect cleaning
procedures used to repair defects in the oxide film (i.e. rough grinding or
scratches that have occurred in assembly prior to sanitary service) and
removes substances (i.e. dust, dirt, iron particles, rust, weld splatter, heat tint,
oil grease, adhesives and inclusions) that can lead to damage of the protective
oxide film.
An alkaline detergent removes any dirt, grease, oil or adhesives that can
prevent the passivation chemicals from acting on the stainless steel surface.
Without the cleaning step, the passivation chemical step may be rendered
ineffective. A thorough rinse is also necessary to remove the caustic ensuring
that there is no mixture of acid with base solutions. The passivation chemicals
are generally made of nitric, phosphoric or citric acid to dissolve the iron
particles.
Within PepsiCo, passivation is a multistep process (rinse, wash, rinse, acid,
rinse). The steps are as below:
• Clean the surface of the metal with an alkaline cleaner to remove any oils
or grease.
• Rinse it.
• Use nitric or citric acid with the following temperatures, concentration
and time.
Product Percent Duration (complete Temp ( ºC / ºF)
(weight %) immersion-minimum
minutes)
Acid solutions are hazardous and must only be handled by trained authorized
personnel wearing the appropriate protective equipment. All equipment and all
mixing operations shall be located in a designated safe area. All necessary
safety ropes or isolation barricades to enclose all working areas shall be
installed prior to the commencement of passivation operations. In the interest
of safety, a supply water connection shall be installed locally in the event of a
chemical spillage.
Effectiveness of the cleaning and passivation can be determined by Water
Immersion test, High Humidity Test or Salt Spray test as defined in ASTM A
967-99. Following passivation, a 3-Step Hot CIP (minimum) shall be conducted
on the passive equipment prior to production.
11.10 References
• EHEDG Guidelines
• Ecolab, Sanitation Procedures
• PWF Engineering Standards
• Dairy Hand Book/ Tetrapak
• GEA, Process Engineering/ Valves
• Krones, Cleaning Procedures Manual
• QTG Passivation Specification
• ASTM, A 967-99, Standard Specification for Chemical Passivation
Treatments for Stainless Steel Parts, (http://www.astm.org)
2. Clean Using a foaming device, Approved alkaline cleaner as per 10 - 15 min Foam the area thoroughly.
cover all areas with an supplier-recommended
alkaline cleaner and allow concentration.
the foam to loosen and
emulsify the soils. Do not
allow foam to dry. If foam
dries, reapply foam before
rinsing.
4. Sanitize Sanitize the surfaces with Approved sanitizing solution as per As per Administer using supplier-
approved sanitizing supplier-recommended supplier recommended method.
solution. concentration.
2. Clean Prepare solution of Alkaline Approved alkaline cleaner as per Avoid contact with
cleaner in a plastic spray supplier-recommended electrical surfaces/light
bottle or stainless bucket and concentration. bulbs.
hand clean vents, ledges and
ceiling tiles with brush
designated for non-food
contact surfaces, cloth or
non-abrasive pad. A soft
pad/cloth should be used for
light covers.
3. Final Rinse Wipe/ Rinse areas with damp Allow areas to air-dry.
cloth.
2. Clean Brush inside of drain with a Approved alkaline cleaner as per 10 - 15 min Clean the area
designated drain brush supplier-recommended thoroughly.
using an alkaline cleaner. concentration.
4. Sanitize Sanitize the drain with Approved drain sanitizer as per As per Administer using
approved drain sanitizer. supplier-recommended supplier supplier-recommended
concentration. method. Replace drain
covers following sanitizing
step.
12.2.2.1 BSC – 4 Conveyors and Conveyor Shields and BSC – 23 Conveyors and Accumulation
Tables
Step Procedure Compound Minimum Objective/Comment
Time
1. System Cover all electrical panels, Prepare the conveyors
Preparation motors, and sensors with and shields prior to
plastic wrap. cleaning.
3. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Foam the conveyors and
all areas with an alkaline supplier-recommended framework thoroughly
cleaner and allow the foam to concentration. inside and out prior to
loosen and emulsify the soils. CIP. Hand scrub guide
Do not allow foam to dry. If rails with “green pad”
foam dries, reapply foam Approved acid cleaner as per while wearing rubber
before rinsing. supplier-recommended gloves.
concentration.
4. Final Rinse Rinse all surfaces thoroughly Water Remove loosened soil and
with a high-pressure water chemical residue.
system.
12.2.2.2 BSC – 5 Filler (External) and BSC - 6 Syrup Blend System and BSC – 21 Empty Bottle
Rinser
Step Procedure Compound Minimum Objective/Comment
Time
1. System Cover all electrical panels, Prepare the filler
Preparation motors, and sensors with (external) prior to
plastic wrap. cleaning.
3. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Foam the filler and
all areas with an alkaline supplier-recommended framework thoroughly
cleaner and allow the foam to concentration. inside and out prior to
loosen and emulsify the soils. Approved acid cleaner as per CIP. Be sure to remove
Do not allow foam to dry. If supplier-recommended sealing rubbers, hand
foam dries, reapply foam concentration. clean and place in a
before rinsing. sanitizing solution after
Twice monthly, the alkaline rinsing.
foam can be replaced with
acid foam.
5. Sanitize Sanitize the filler (external) Approved sanitizing solution as per As per Administer using
with approved sanitizing supplier-recommended supplier supplier-recommended
solution. (If no rinse concentration. method.
concentrations are used, then
rinsing is not required,
otherwise rinsing is a must.)
2. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Foam the capper
all areas with an alkaline supplier-recommended thoroughly inside and out
cleaner and allow the foam to concentration. prior to CIP. Be sure to
loosen and emulsify the soils. foam inside and
Do not allow foam to dry. If underside of framework.
foam dries, reapply foam
before rinsing.
4. Sanitize Sanitize the capper with Approved sanitizing solution as per As per Administer using
approved sanitizing solution. supplier-recommended supplier supplier-recommended
(If no rinse concentrations concentration. method.
are used, then rinsing is not
required, otherwise rinsing is
a must.)
5. Final Rinse Rinse with fresh water. Water Inspect for any mold
present.
2. Sanitize Wipe surfaces with sanitizing Approved sanitizing agent. Remove all plastic dust
cloth. Use a long slim brush and residue.
to push the cloth to clean the Cap hopper and
chute, if necessary. Allow chute/unscrambler
equipment to air-dry. must be kept clean and
dry and never directly
foamed or sprayed.
2. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Foam the capper storage
all areas with an alkaline supplier-recommended bin thoroughly inside and
cleaner and allow the foam to concentration. out prior to CIP.
loosen and emulsify the soils.
Do not allow foam to dry. If
foam dries, reapply foam
before rinsing.
4. Sanitize Wipe inside of capper storage Approved sanitizing agent. Inspect filter on cap
bin with sanitizing cloth and airveyor system and
allow to air-dry. change if necessary.
Filters must always be
clean for the system to
operate properly and to
stay sanitary.
2. Clean Using a foaming device, Approved alkaline cleaner as per 10 - 15 min Foam the platforms and
cover all areas with an supplier-recommended rubber mats thoroughly.
alkaline cleaner and allow concentration.
the foam to loosen and
emulsify the soils. Do not
allow foam to dry. If foam
dries, reapply foam before
rinsing.
3. Intermediate Rinse all surfaces thoroughly Water Remove loosened soil and
Rinse with a high-pressure water chemical residue.
system.
4. Sanitize Sanitize the platforms and Approved sanitizing solution as per As per Administer using
rubber mats with approved supplier-recommended supplier supplier-recommended
sanitizing solution. concentration. method.
12.2.2.8 BSC – 11B. Empty Bottle Air Rinser - Daily if on extended production intervals.
Step Procedure Compound Minimum Objective/Comment
Time
1. Set up Remove any downed NA Set up.
packages from system. De-
energize the deionizers and
turn off air flow. Remove
guards, ducts and inspect.
2. Vacuum Using a vacuum system with NA As needed to Remove soils from rinser.
a HEPA filtered exhaust, thoroughly
remove all fiber dust and remove soils.
particulate from all areas.
3. Sanitize Wipe all surfaces of the Approved sanitizing solution as per As per Administer using a clean
chamber, removed guards supplier-recommended supplier cloth or pre-moistened
and ducts with an approved concentration. wipe.
no rinse sanitizer. Allow to
air-dry.
4. Reassemble Inspect surfaces to ensure NA Reassemble and place
air-dry. Reassemble guards unit back in service per
and ducts. Place unit back OEM instructions.
in service.
12.2.2.10 BSC – 12 Syrup Tanks (External) and BSC -13 Pre-/Post-Mix Equipment (External)
Step Procedure Compound Minimum Objective/Comment
Time
1. System Cover all electrical panels, Prepare the syrup tanks
Preparation motors, and sensors with (external) prior to
plastic wrap. cleaning.
3. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Foam the tanks starting
all areas with an alkaline supplier-recommended from the bottom of the
cleaner and allow the foam to concentration. tank and work towards
loosen and emulsify the soils. Approved acid cleaner as per the top.
Do not allow foam to dry. If supplier-recommended
foam dries, reapply foam concentration.
before rinsing.
Twice monthly, the alkaline
foam can be replaced with
acid foam.
4. Final Rinse Rinse all surfaces thoroughly Water Remove loosened soil and
with a high-pressure water chemical residue.
system.
12.2.2.11 BSC – 14 COP Cleaning of Small Parts: Gaskets, O-Rings, Sample Ports, Scoops,
Ladles, In-Line Strainers, and Other Small Parts Not Part of the CIP System
Step Procedure Compound Minimum Objective/Comment
Time
1. Clean Place all disassembled small parts Approved alkaline cleaner 15 min Foam the equipment starting
in an alkaline cleaning solution as per supplier- from the bottom of the tank and
for manual cleaning. recommended work towards the top.
After soaking in alkaline cleaning concentration.
solution remove parts and hand
brush thoroughly using a
dedicated food contact/
equipment brush.
2. Intermediate Transfer parts into an empty Water Use fresh water to rinse at all
Rinse dedicated food contact/ times. Rinse parts until all
equipment bucket and rinse with Alkaline solution is no longer
treated water or rinse directly with present.
a treated water hose or sink.
3. Sanitize Place all disassembled small parts Approved sanitizing 5 min or as Administer using supplier-
in a sanitizing solution for solution as per supplier- per supplier recommended method.
soaking. recommended If parts are allowed to air-dry on
After soaking in sanitizing concentration. rubber mat, once dry, examine
solution remove parts and allow to all areas for dirt and debris
air-dry on a clean and sanitized prior to reinstallation into
rubber mat or table, or parts may equipment. If any visual soil is
be immediately returned to present, repeat above steps
equipment for air-dry. prior to reinstalling equipment.
Ensure hands are clean and/or
gloves are new prior to handling
parts for assembly.
2. Pre-Rinse Rinse floors with water to the Water Remove soils from areas.
drain.
3. Clean Dampen the floor with 60 °C Approved alkaline cleaner as per Clean the area
(140 °F) water and clean using supplier-recommended thoroughly.
Alkaline wash. Allow the cleaner concentration.
to loosen and emulsify the soils.
Manually scrub the floor with a
dedicated non-food contact/
non-equipment/ environmental
cleaning stiff-bristle brush to
remove soil and rinse with
ambient water.
4. Rinse the area to the drain. Water Remove loosened soil and
Intermediate chemical residue.
Rinse
5. Sanitize - Sanitize the floor with an Approved sanitizing solution as Administer using
Optional approved sanitizing solution. per supplier-recommended supplier-recommended
concentration. method
For BSC 16 (Lights, Vents, Walls, Ledges and Ceilings) see section 12.2.1.2
For BSC 17 (Drains), see section 12.2.1.3.
2. Clean Rinse the area thoroughly Water Do not use chemicals in this area
with a hot water hose. to prevent contamination of
storm drains.
2. Pre-Rinse Rinse the outside and Water Remove soils from waste
inside of the waste receptacles.
receptacle with a water
hose.
3. Clean Loosen any debris from the Approved alkaline cleaner as per Clean the area
waste receptacle with a supplier-recommended thoroughly.
dedicated non-food contact/ concentration.
non-equipment/
environmental cleaning
brush.
Using a foaming device,
cover all areas inside and
outside the waste receptacle
with an alkaline cleaner.
4. Intermediate Rinse the area to the drain. Water Remove loosened soil and
Rinse chemical residue.
5. Sanitize - Sanitize the floor with an Approved sanitizing solution as per As per Administer using
Optional approved sanitizing supplier-recommended supplier supplier-recommended
solution. concentration. method.
2. Clean Manually scrub or foam the Approved alkaline cleaner as per Clean the area
depalletizer with an alkaline supplier-recommended thoroughly.
cleaning solution using a non- concentration.
abrasive pad while wearing
rubber gloves.
3. Final Rinse Rinse all surfaces thoroughly with Water Remove loosened soil and
a water hose. chemical residue.
3. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Foam the airveyor inside
all areas with an alkaline supplier-recommended and out. Be sure to foam
cleaner and allow the foam to concentration. neck guides and rails
loosen and emulsify the soils. thoroughly. Hand clean
Do not allow foam to dry. If with “green pad” while
foam dries, reapply foam wearing rubber gloves.
before rinsing.
4.Intermediate Rinse all surfaces thoroughly Water Remove loosened soil and
Rinse with high-pressure water chemical residue.
system.
2. Clean Foam with alkaline cleaner Approved alkaline cleaner as per 10 – 15 min Clean the area
and using a dedicated food supplier-recommended thoroughly.
contact surfaces/ equipment concentration.
brush, scrub any areas that
have soil buildup.
3. Final Rinse Rinse all surfaces thoroughly Water Remove loosened soil and
with high-pressure water. chemical residue.
2. Clean Foam conveyor, frame and Approved alkaline cleaner as per 10 – 15 min Clean the area
drip pans with alkaline supplier-recommended thoroughly.
cleaner. concentration.
3. Final Rinse Rinse all surfaces thoroughly Water Remove loosened soil and
with high-pressure water. chemical residue.
3. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 – 15 min Clean the area
all areas with an alkaline supplier-recommended thoroughly.
cleaner and allow the foam to concentration.
loosen and emulsify the soils.
Do not allow foam to dry. If
foam dries, reapply foam
before rinsing.
4. Final Rinse Rinse all surfaces thoroughly Water Remove loosened soil and
with high-pressure water. chemical residue.
3A. Clean Using a foaming device, cover all areas Approved alkaline cleaner Clean the area
(Foam) inside and cover with an alkaline as per supplier- thoroughly.
cleaner and allow the foam to loosen recommended
and emulsify the soils. concentration.
Rinse all surfaces thoroughly with
high-pressure water after foaming.
3B. Clean Refill warmer with fresh water and add Approved Alkaline Boil- 1 hour (Boil- Alkaline Boil-Out on a
(Boil-Out/ Alkaline Boil-Out cleaner while water is Out as per supplier- Out) weekly basis and Biocide
Biocide) still cool. Start re-circulation and turn recommended is a daily treatment.
temperature control to the highest level concentration.
and re-circulate for 1 hour. Turn off Approved Biocide as per
pump and re-set temperature control. supplier-recommended
Empty water and rinse with high- concentration.
pressure water. Inspect for debris and
odor. If present, repeat Boil-Out Step.
Refill warmer with fresh water and use
approved Biocide.
2. Rinse Using potable water, rinse Potable Water 2 min total Rinse the cooling tunnel.
cooling tunnel for 2 minutes Temperature of 27 – 49 °C (80 – 120 °F) in each
total in each section split section
evenly between spray bar and
spray balls. Drain at the end of
the step.
3. Sanitize Sanitize using an approved, As per supplier-recommended 10 min total Sanitize the cooling
registered sanitizer such as concentration at ambient temperature. in each tunnel.
chlorine, peracetic acid or section
QUAT in the cooling tunnel for
10 minutes total in each
section split evenly between
spray bar and spray balls. Fill
cooler with water at the end of
the step.
Notes:
Water biocide treatment shall be maintained between 0.5-4.0 ppm free Cl.
Sodium hypochlorite at a pH of 6 to 8.
Chlorine dioxide at a pH of 6 to 10.
Peracetic acid maintained between 20 - 50 ppm or quaternary ammonium per chemical supplier label
declaration.
2. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Clean the area
all areas with an alkaline supplier-recommended thoroughly.
cleaner and allow the foam to concentration.
loosen and emulsify the soils. Approved acid cleaner as per
Do not allow foam to dry. If supplier-recommended
foam dries, reapply foam concentration.
before rinsing.
Monthly, the alkaline foam
should be replaced with acid
foam.
3. Final Rinse Rinse all surfaces thoroughly Water Remove loosened soil and
with a high-pressure water chemical residue.
system.
2. Clean Using a foaming device, cover Approved alkaline cleaner as per 10 - 15 min Be sure to foam the floor
all areas with an alkaline supplier-recommended area thoroughly during
cleaner and allow the foam to concentration. the foaming of equipment.
loosen and emulsify the soils.
Do not allow foam to dry. If
foam dries, reapply foam
before rinsing.
4. Sanitize Sanitize the surfaces with Approved sanitizing solution as per As per Administer using
approved sanitizing solution supplier-recommended supplier supplier-recommended
only if odors still exist after concentration. method.
cleaning step.
2. Clean Manually wash the Approved alkaline cleaner as per Where rubber gloves
ingredients storage area with supplier-recommended during cleaning.
an approved alkaline cleaner concentration.
using a dedicated food
contact/ equipment brush.
3. Final Rinse Rinse thoroughly with a Water Remove loosened soil and
water hose. chemical residue.
Allow area to air-dry.
2. Clean Prepare solution of alkaline Approved alkaline cleaner as per Avoid contact with
cleaner in a plastic spray supplier-recommended electrical surfaces/light
bottle and spray the cleaner concentration. bulbs.
on and wipe it off with a non-
abrasive pad or non-fibrous
cloth.
UV - Procedures for cleaning and sanitizing UV can vary and it is recommended that
the manufacturer’s instructions are followed. In addition, the quartz sleeve is to be
cleaned when the transmittance falls below 60% and at changeout.
Water Storage Tanks – Procedures for protected and unprotected water storage
tanks are defined and recommended to occur at least annually (protected storage)
and once per month (unprotected storage) or more frequently based on micro
results.
Water Distribution Pipes – The procedures for water distribution pipes are defined
and should occur at least once per year or more frequently based on the micro
results.
removal of this type of foulant (oxides of iron and manganese, inorganic silica,
hardness deposition, etc.).
To accomplish this, the first cleaning solution is acidic, adjusted to
approximately pH 2.5.
Cleaning solutions are often supplied with additives that will increase the
efficiency of the cleaning process.
These include wetting agents, polyphosphates, anionic surfactants, and often
proprietary blends of these compounds. No proprietary compounds should be
used unless their components are disclosed as acceptable for the intended
use in a food/beverage plant.
5. Remove the top manhole and continue to drain water from the filter
until the water level is a few inches below the top of the manhole cover
opening.
6. Measure the distance (in inches) between the media bed level and the
manhole opening.
7. Add the required amount of pre-dissolved chlorine solution into the
water above the media.
8. Slowly begin adding water to the filter by manually operating the face-
piping valves. Raise the water level in the vessel until it is even with
bottom of the top manhole. Thoroughly mix water and chlorine, to
promote a uniform concentration.
9. Allow 10 minutes for the chlorine to contact the upper portion of the
filter.
10. Open the drain valve on the media filter and slowly drain the solution
until the water level is approximately 2 – 3 inches (5-8 cm) above the
media. Then close the drain valve.
11. Allow a 30-minute contact time.
12. Replace the top manhole cover.
13. Using the filter’s face-piping valves, slowly refill the filter with water.
14. Close the vent valve after all of the air has been removed from the top
vessel and allow the filter to be re-pressurized.
15. Flush the media filter through bottom drain until water samples are
free of chlorine. If using treated water from the clearwell, flush until
the chlorine residual is equal to the clearwell residual.
16. Place the face-piping valves on media filter in the rinse/rewash mode
and flush the excess chlorine out of the filter.
CAUTION!
Do not use phosphoric acid in the presence of a strong chlorine
sanitizing solution. Noxious fumes may result.
Note: 8 to 20 ppm chlorine is not a problem.
13.4.3 Polishers
The cleaning and sanitizing procedures for the housing will vary with polisher
type. Follow the manufacturer’s recommendation. Clean and sanitize the
housing at changeout.
13.4.4 UV
The cleaning and sanitizing procedures for UV treatment systems can vary and
the manufacturer’s recommendation should always be followed.
Carbon Purifier Monthly, ensure the The plant raw water supply is
conditions described to “potable.”
the right are satisfied. The plant complies with the water
“minimum mandates.”
A written protocol is in place with
microbiologic action limits and clearly
defined procedures, roles and
responsibilities.
Micro measured on water after carbon
purifier and prior to UV are within the
following limits:
– 500 cfus/1 mL for Total Plate
count bacteria (treated water after
carbon filter)
– 0 cfu/ 100 mL for Total Coliform
bacteria
13.7 References
PI Water Quality Tool
PepsiCo Global Treated Water Manual
14.1.3 Fogging
Fogging is a method of controlling microorganisms in an enclosed area,
whereby atomized chemicals or chemical vapor completely fills the area to
suffocate and kill the microorganisms present. Whenever fogging is conducted,
the effectiveness must be verified through microbiological testing to ensure the
applications are warranted.
Fogging usually involves the following phases:
1. The target area is covered to create a sealed environment.
2. The fogging agent is released into the target area.
3. The target area remains sealed for a set period of time while the fogging
agent percolates through the space to terminate any microorganism
infestation in the target area.
4. The target area is ventilated to remove the gases released by fogging and
to make the area safe for human activity.
equipment used. In addition, the way the equipment is set up and the
specific area being treated will impact the output.
3. Set the fogging equipment to start operation with a predefined start-up
delay that allows sufficient time to evacuate the target area. Allow at
least 2 hours of contact time during fogging.
4. To obtain and maintain the maximum fogging effectiveness, properly seal
the target area by closing all ventilation systems, locking doors/
windows, and sealing door openings.
14.3 References:
PI Quality Manuals, Food Safety and Sanitation Section
Baseline
Test
Validation
Monitor
15.2.1.1 Prerequisites
Plant must have 12 weeks of consecutive CIP effectiveness data that is
in-specification (e.g. rinse water micro data).
Plant must have 1 active member with Sanitation and Microbiology
certification or demonstrated proficiency.
Implementing the process must be approved in writing by Region/ Sector
Quality.
15.2.3.1 Prerequisites
Plant must have a CIP system which meets the sanitary design criteria,
including a fully automatic system with no dead legs. Where COP is
required, it is documented and performed at the correct frequency.
Plant must have 12 weeks of consecutive CIP effectiveness data that is
in-specification including finished product and aseptic surge tank data (if
available).
Plant must have 1 active member with Sanitation and Microbiology
certification or demonstrated proficiency.
Implementing the process must be approved in writing by Region/ Sector
Quality.
The following table outlines the microbiological sampling points that are
required for each step of the extension process. Note: For information on
additional sampling points see the Note in 15.2.2.115.2.2.1.
Air Open Plates At the end of See below TPC < 1 cfu
production Yeast < 1 cfu
Mold < 1 cfu
rinsing nozzles at the end of production (eventually also to the beginning), after
the “PRODUCTION” mode has been selected, using the dedicated switch on the
filler control board.
15.2.3.9 Sampling of Surface Swabs
The following sampling points must be tested for surface swabs:
Note: For information on additional sampling points, see the Note in 15.2.2.1.
1. Caps chute
2. Filler exit star-wheel base frame
3. Filler inlet star-wheel
4. Capper exit star-wheel
5. Filling valves (5 samples)
6. Filler bottle support base frame and drain
7. Filler dummy bottle loading/unloading system
8. Filler bottle neck support
9. Filler rear manipulation gloves
10. Filler exit star-wheel
11. Filler exit area
12. Base frame under capper
13. “Pick and place” star-wheel
14. Capper heads (5 samples)
15. Filler front manipulation gloves
16. Rinser grippers and nozzles (5 samples)
17. Rinser inlet area
18. Rinser star-wheels base frame
19. Rinser exit star-wheel
20. Rinser – filler transfer star-wheel
21. Rinser front manipulation gloves
22. Rinser rear manipulation gloves
15.2.3.10 Sampling of Air Open Plates
The following sampling points must be tested for the air open plates:
Note: For information on other sampling points see the Note in 15.2.2.1.
1. Base frame under capper
2. Filler inlet star-wheel base frame
3. Base frame under dummy bottles loading/unloading system
4. Rinser – filler transfer star-wheel base frame
5. Rinser inlet star-wheel base frame
15.2.3.11 Sampling of Sterile Caps
Sterile caps have to be withdrawn from the caps elevator and placed in a sterile
bag. Sampling includes 20 caps (1 cap per sterile bag). Analysis of the caps is
performed using the “Membrane Filtration Technique” in which the liquid is
filtered by means of a 0.45 um sterile membrane. The membrane is then
Strainers Each Shift Each Shift Each Shift Each Shift Each Shift NA
Cleaning
Calibrate NA Monthly NA NA NA NA
Temp Gauges
Calibrate pH NA NA NA Monthly NA NA
Controller
* Or When Carbonate Level is > 1% or when Caustic solution is brownish or visibly dirty (whichever is
first)
Chapter 7
7-6 7.2.1 PepsiCo CIP Added 3 new protocols: High Acid Chilled
summary Matrix Distribution non-ESL & ESL; Low Acid Chilled
Distribution ESL; High Acid Chilled Distribution
Ultra Clean. Changed Chilled Juice to Chilled
Distribution under Product/Process
7-32 – 7-34 7.2.2.22 V Existing protocols with new numbers due to the
7.2.2.23 W addition of the 3 new protocols above.
7.2.2.24 X