10.1201 9781003158653-14 Chapterpdf

Chapter 12
Cleaning and Sanitization for

Aseptic Processing Operations
Jeffrey Merritt
CONTENTS
12.1 Introduction 256
12.2 Equipment Preparation and Set Up (EPSU) 256
12.3 Principles of Sanitation 259
12.3.1 Principles of Sanitation 259
12.3.2 Personal Hygiene 259
12.4 CIP (Clean-In-Place) 260
12.4.1 Flow (Scrubbing or Mechanical Force to Remove the Soil) for UHT Systems 261
12.4.2 Chemical Concentration 263
12.4.2.1 UHT Processor 263
12.4.2.2 Sterile Tank 263
12.4.2.3 Fillers 263
12.4.3 Time 264
12.4.4 Temperature for Cleaning UHT Systems 264
12.4.5 For Sterile Tanks 265
12.4.6 For Fillers 266
12.4.6.1 For ESL Fillers 266
12.4.7 Pulsing of Valves 268
12.4.8 Ingredients 269
12.5 Clean-Out-of-Place (COP) 270
12.6 SIP (Sterilization-In-Place) 271
12.7 Aseptic Intermediate Clean (AIC) 271
12.7.1 Concentration of Chemical 272
12.7.2 Sterile Tanks 272
12.7.3 Fillers 273
12.8 Validation and Verification 273
12.8.1 Validation 273
12.8.2 Verification 274
12.9 Passivation 274
12.9.1 Passivation Process 275
12.9.1.1 Some Preliminary Considerations 275
DOI: 10.1201/9781003158653-14 255

256 Cleaning and Sanitization for Aseptic Processing Operations
12.9.1.2 Passivation Process 275

12.9.1.3 Cleaning and Passivation 276
12.10 Maintenance 277
12.10.1 Preventive Maintenance 277
12.10.2 Breakdown Maintenance 278
12.11 Change Control Management Program (CCM-P) 278
12.11.1 Program Change 278
12.11.2 Ingredient Change 279
12.11.3 Procedure Change 279
12.11.4 Chemical Change 279
12.12 Environmental Cleaning 279
12.12.1 Environmental Monitoring 279
12.12.2 Air Quality 280
12.12.3 Zoning and Segregation 280
12.12.4 Other Items 281
12.13 Summary 281
12.14 Definitions 281
12.15 Acronyms 282
References 283
12.1 INTRODUCTION
Cleaning and sanitization procedures have to be considered as an integral part of food produc-
tion. No matter how well the production plant may be designed, if cleaning and sanitation are
not possible or not done properly, it is impossible to produce high-quality and safe products.
Food production is intertwined with cleaning and sanitization and are mutually inclusive.
Cleaning and sanitization are one of the most important aspects of food manufacturing. This
has been made amply clear by announcements of food recalls stemming from contamination
with bacteria and foreign matter (CDC, 2021).
Cleaning and sanitization of aseptic processing and packaging unit operations is complex
and should get attention the same or more as in the food and beverage industry using canning or
“terminal sterilization” technologies.
This chapter provides principles and procedures for cleaning and sanitization for manufac-
turing operations focused on aseptically processed and packaged fluids, and ESL-refrigerated
products. Also, discussed are concepts of CIP, COP, SIP, AIC, validation and verification, passiv-
ation, maintenance, change control management, and environmental cleaning.
This chapter is intended to be an overview. Further reading of other references and publica-
tions cited in the Reference section is recommended to understand the scope, design, delivery
of cleaning, and sanitization for consistent production of high-quality safe products day to day.
Collaboration and leveraging of the institutional knowledge of vendors of cleaning and sanitiza-
tion chemicals is paramount, and is necessary, as this is a team sport (IAMFES, 1996, Katsuyama,
1993, Loncin and Merson, 1979, Troller, 1983, ASTM, 1994, Ecolab, 2022).
12.2 EQUIPMENT PREPARATION AND SET UP (EPSU)

As we start discussing the Cleaning and Sanitation of Aseptic and ESL equipment, it is important
to understand that cleaning is the first step in producing safe, quality food. It is not the last step.
12.2 Equipment Preparation and Set Up (EPSU) 257
As we talk with manufactures of these products, we hear a common theme that is “CIP is
down time and cost us production time.” This is incorrect. There are several factors that will
increase uptime:
• Clean equipment
• Proper and consistent preventive maintenance programs (PM)
• Employee hygiene
• Employees that are trained and receive continuous training
• Clear concise and continuous communication between management and the employees
Following the above guidelines can help increase the number of salable products.
There is an old saying: “Pay me now or Pay me later.” Taking the time to do it right the first
time, every time, is less expensive than waiting for the failure to trigger corrective action and
resolution of the issue. If we do it correctly the first time and follow the pattern of doing it right,
we have less spoilage; in addition, the equipment runs correctly, which means you have more
consistent and sustained runs.
We should not accept that we are going to have spoilage and build this loss into your budget.
Spoilage should not be accepted; it needs to be resolved and fixed. If we don’t do it right the first
time, you end up with more cost, due to spoilage, unplanned downtime because preventive main-
tenance was skipped and, in some cases, it could result in a recall of product.
In this chapter, we will discuss these topics and how they influence your operation. A clean,
properly maintained system is a reliable system. As we go forward, it is important to remember
that the cleaning of the UHT, sterile tanks, and fillers are generally the same for aseptic as for
ESL. Some ESL fillers will require more hand-cleaning of pumps, valves, screens, or filters. When
we get into the second and third steps, there may be more differences on the sterile tanks and the
fillers, we will discuss more as we proceed.
There are five steps in getting the equipment ready for production of safe and high-quality
product, as shown in Figure 12.1.
Step 0: Preventive maintenance

Step 0 is the preventive maintenance and prerequisite step. This step is to make sure
you are ready to start the process up. This step requires that you have a PM (preventive
maintenance) program set up and you are following it. It also requires that you have
prerequisites in place. These prerequisites should be used to help train and guide your
employees. Some of these prerequisites would include the following:
• Proper design of equipment and plant
• Continuous education, learning, and training for all employees
• GMP polices
• SSOP documents
• SOP documents
Step 1: Cleaning
Step 1 is the cleaning of your equipment, remember this is your first step not your
last step. With a properly cleaned system, you start the production with the best chance
of success. Cleaning is the task of removing all soils from the equipment. This includes
both internal and external cleaning of the equipment. We need to remember this is not
the step where the button is pushed, and you walk away from it. This is the time that you
need to monitor what is going on. Are there any leaks? Are the chemicals being added,
Steep - 0
Prev
ventive
Main
ntenance
&
Pre-rrequistes
Step - 4 Step - 1
Productio on Cleaningg
Production of
Safee and
High-QQuality
Fo
ood
Step - 3
Step - 2
Pre-
n
Sterilization Sanitizatioon
(SIP)
Figure 12.1 Chart to illustrate the five steps in equipment preparation and setup (EPSU) required for
production of safe and high-quality safe product. Step 0: Preventive maintenance and prerequisites. Step 1:
Cleaning CIP & COP. Step 2: Sanitization. Step 3: Presterilization (SIP). Step 4: Production.
and do you have the correct concentration? This is one of the best times to determine if
the equipment is functioning correctly.
Step 2: Sanitization
In step 2, you reduce or eliminate microorganisms that may be left on the clean
surface. Don’t confuse this with sterilization as that comes later. In this step, you are
getting the equipment ready so that when you do sterilize, it will have the highest prob-
ability of being successful.
Step 3: Presterilization (SIP)
Step 3 is presterilization (sometimes called SIP—sterilization-in-place—some will
call it sterilization in progress). In this step, you bring the equipment that is going to run
the product to the level of sterility needed for the process you are going to be running.
Aseptic SIP is a regulated step (21CFR113.40(g)) and the goal is to bring all equipment
and food-contact surfaces to a state of commercially sterility, customarily an F0 of 30–50
minutes for running low-acid aseptic products. For ESL, the level of commercial sterility
is not defined by the regulation and is left to each processor to design and deliver. All
equipment must be brought to this state, including the hold tube, homogenizer, cooling
section, the sterile or storage tank, the filler, and all the connecting tubing.
Step 4: Food production
In Step 4, you are bringing the product you are running to the level of sterility that
you have determined you want for this product. If you are producing an aseptic product
you are going to reduce or eliminate the microorganisms to the level that you do not
need to refrigerate the product. If you are doing an ESL product, you are using refrig-
eration to help with your shelf life. Your equipment producing this product will reduce
12.3 Principles of Sanitation 259
the microorganisms to a level that you will reach the shelf life that you have set for this
product.
12.3 PRINCIPLES OF SANITATION
We perform sanitation procedures to produce safe quality food and beverage. Sanitation is the
process by which the equipment and environment is cleaned of dirt, pathogens, and bacteria
from product-contact surfaces, as well as incidental product-contact areas, the air, the exterior
of equipment, and the area the equipment is in (walls, floors, ceilings). Having a proper sanita-
tion program is a major factor in producing hygienic and safe food. This is done using automated
and manual cleaning techniques that will use chemicals to clean and sanitize all areas. They
may use steam, hot water, or chemicals to sanitize and sterilize the equipment. Sanitation also
includes the proper hygiene of the personal.
12.3.1 Principles of Sanitation
The principles of sanitation start with personal hygiene and equipment that is designed to be
able to be cleaned and sanitized. Sanitation starts before the equipment is designed and built.
The engineering and design will ensure that it follows 3A/EHEDG standards. These two groups
look at practical and theoretical design to make sure the equipment is cleanable to ensure the
production of safe, quality food. As the equipment is designed, it looks to ensure that there are
no dead legs (area that cannot get sufficient flow or turbulence to clean). The surfaces need to
be smooth and free from sharp angles. It needs to ensure that any vessel, pipe, or tube in the
system can be cleaned and fully drainable (preventing pooling or low-flow areas that will affect
cleaning).
The issue comes after design and is during the installation. At times pipes are moved or
changed due to space constraints. These changes are needed due to product specifications, or
lack of utilities. As a result, sometimes no thought is put into how this is going to affect cleaning.
This includes but is not limited to changing pipe diameters, extra elbows, and pipe being cut off
and capped due to relocation or change of flow; older equipment being repurposed for new prod-
ucts or processes; the proper materials being used. Is the material correct for the process being
used? For example, using 304 stainless steel in a hold tube to produce a product with a higher
salt content at temperatures over 250°F will cause pitting in the pipe which then creates harbor
areas that are more difficult to clean.
As the equipment is built and installed, we must look if it is cleanable? Also, answer the follow-
ing questions: (1) Can the necessary flow rates be achieved? (2) Are the spray balls located cor-
rectly, and can the correct flow and pressure to each spray ball be achieved and maintained? (3)
Do the valves pulse and clean both sides of the seats? These and other questions will be answered
as we go through this chapter.
12.3.2 Personal Hygiene
Before starting the cleaning and sanitizing of the machine, we need to make sure that those
who are involved in the cleaning and sanitizing are following the correct GMP. This starts at the
management level; they must be the example and follow the GMP policies in all aspects, includ-
ing handwashing. Hands must be cleaned and washed frequently. If you change the task you
are doing, you need to wash your hands again. Hand cleaning facilities must be easily accessed
and should be in every room. Maintenance personnel need to be sure they have removed all the
grease and other contaminants from their hands and clothes prior to working on equipment
in the aseptic or ESL process (UHT processors, sterile tanks, fillers). Tools need to be clean and
sanitized as well prior to use in these areas.
If using disposable gloves, they need to change them frequently. Just like your hands, if you
pick something up from the floor, those gloves are no longer clean. Gloves if used should be put on
for that task and then disposed of before going to the next task. Don’t wear gloves for long periods
of time as they are then just as dirty as not washing your hands. Improperly using gloves can lead
to many environmental contamination issues. Treat them the same as your hand.
Clothing: If your uniform becomes overly soiled, you should change it (especially if dealing
with allergens or around sterile environments); this will lead to contamination issues. If hats are
worn, they need to be clean and free of contaminants. Cloth ball caps are hard to keep clean and
should be avoided. If they are allowed, then you need to establish how you are going to keep them
clean. Bump caps and hard hats can be cleaned and sanitized daily or if they get dirty.
Footwear: Your feet travel throughout the facility and whatever you walk through is tracked
to your next location. Clean and/or sanitize your footwear whenever you enter any area of the
plant. If you don’t have a captive shoe program, they need to be cleaned when you enter the plant.
Each area you go into needs some sort of protection to sanitize and or clean the bottom of the
footwear as you enter this area. But regardless of what you use, they are only as good as they are
maintained and controlled.
Foaming system that sprays sanitizer or cleaner on the floor is used to keep a layer of foam on
the floor. This foam must be walked through to enter the area. It is good, but only in wet areas as
it produces wet floors. Dry sanitizers that you walk through are good for dry areas, but it requires
that the floor around them be swept up frequently. Foot baths are used in many places but if they
are used, they must be cleaned and recharged at least every shift and usually more often for them
to be effective.
• Captive boot policy works well in areas where the employee is restricted in their move-
ments. And footwear is not allowed out of these areas. You still need to clean your foot-
wear daily.
Hair and beard nets: These need to be replaced daily or if they get dirty. Need to be properly worn.
12.4 CIP (CLEAN-IN-PLACE)
It is important to remember that it does not matter whether it is ESL or Aseptic: the systems will
clean the same. The principles of CIP consist of four factors:
• Flow
This is the mechanical action that is created to produce the scrubbing effect usually
in a pipe that is turbulence.
• Concentration
It is the % of chemical to water ratio based on the chemical used and the quality of the
water, product being cleaned, and the equipment being cleaned.
• Time
It is the time a chemical is in contact with the equipment being cleaned.
• Temperature
It implies the correct temperature for the chemical being used and the equipment
being cleaned.
These four factors if used correctly will clean the equipment, each factor is adjusted for the
product and the equipment. If you cannot get one of them, you must make it up with the other
three. But there is a limit to each factor and other factors that may contribute to poor clean-
ing. We want everyone to remember that the chemical is only a small part of the fluid going
through the line. Water is over 95% of the fluid and it is important to understand that the
makeup of the water can affect the cleaning, for both good and bad. If you are using untreated
water, it could be high in minerals. This affects the cleaning because now the chemical must
overcome the water before it can clean the organics of the products. This reduces the effective-
ness of the cleaning or will require the use of additives to condition the makeup of the water
and could also result in the overuse of chemicals. During the cleaning process, we will discuss
each one of the factors to look at what happens. At the end of the chapter are a few tables cov-
ering the most common factors: time, temperatures, flow, and concentrations for the different
types of equipment.
12.4.1 Flow (Scrubbing or Mechanical Force to

Remove the Soil) for UHT Systems
In UHT processing, one of the items that cause them to be more difficult to clean and control is a
condition known in the industry as fouling. Fouling occurs on the product to metal surfaces due
to types of ingredients, the flow of the product, and the heat which causes the product to burn
or to caramelize the sugars. The longer you run, the thicker and thicker the fouling layers get. In
addition, as one switches from product to water and back during the runtime, layers of miner-
als might occur and that can turn a simple soil into a complex soil. To reduce this fouling, the
frequency that an AIC is performed is important. Running at the designed flow rate (do not slow
down the system to reduce product to water transitions) and running at the correct tempera-
tures for the product are important to help control the fouling of the equipment.
One factor that is sometimes hard to achieve is getting enough flow to clean an aseptic or
ESL processor. Without the proper flow, it becomes very difficult to remove the layers of fouling.
Many times, they are set up for the pipe size to get the flow and this generally will not be enough
to clean the equipment. I have followed and found that if I can get 1.5× the flow of maximum
product flow, the system will generally clean at a minimum and would result in 30% overproduc-
tion flow rates. On systems that have Flash Vessels or Steam Infusion Chambers, they will have
spray balls that need to have the proper flow rate to them. This usually involves a valve and an
orifice to create the proper flow and pressure as this will be pulled off the mainstream.
Without the proper flow, it may not be possible even with chemical additives to get the proper
clean. When designing, testing, and validation of the system, it is important to ensure you’re
getting the proper flow. The reason behind needing the higher flow can be related back to the
temperatures the product is being processed at along with the type of product. In addition, espe-
cially on direct systems, there is more equipment that is involved than disrupt the flow due to
spray balls or flow patterns that require a portion of the flow to split off.
Hold tubes usually have more fouling due to the high temperatures, this results in needing
some way to penetrate this complex soil to get it to release from the stainless piping. This can be
done by flow or the addition of additives to help penetrate the soil. Even with the additives, you
Figure 12.2 Pictures of ineffectively cleaned hold tubes in a UHT sterilizer: (a) Middle of the hold tube;
(b) End of the hold tube; (c) “Legal” transducer at the exit of the hold tube.
need enough flow and chemicals to carry it out of the system. These pictures show hold tubes and
a transmitter cleaned with the improper flow and chemicals (Figure 12.2).
• The equipment was able to be cleaned once we were able to get the flow up and the
proper concentration of chemicals. We did not need additives on this one.
• On an indirect system, you have more heating area to get to the elevated tempera-
tures and as result more pressure drop through the system that must be compen-
sated for. A system that is not properly balanced between the media side and the
product side (delta T) will result in higher spots of burn that will take more flow or
additives to remove. Figure 12.3 shows an example of a plate that had a hot spot and
began to plug off. These become very difficult to clean and at times they may have
to be opened and hand cleaned.
Figure 12.3 Final plate in an indirect heat exchanger showing product burn-on due to high ΔT (tempera-
ture difference) between heating medium and product.
12.4.2 Chemical Concentration
12.4.2.1 UHT Processor
There are many factors that go into determining the necessary concentration to clean the pro-
cessor. Concentration will start at 2 3% active caustic and will need to be adjusted up or down
based on your product mix. Also, this will change depending on your chemical; if it is commodity
caustic, it may go up, and if it is a built caustic cleaner with additives, it may go down. If you are
running a thin juice-type beverage, it will not need as much caustic as a system running a plant-
based product or a protein drink. Concentrations will need to be adjusted accordingly. More
chemicals can be added, but remember you will get to a level that this will reduce the effective-
ness of the clean.
Acid will start at 0.7–1.5% and will need to adjust up or down based on your product and water
makeup.
CIP is performed mainly using temperature to control. CIP is performed by controlling the
temperature of the wash either at the preheater or the hold tube. If on a direct heating system,
they also run the flash vessel to remove that extra water. Most systems start the step (phase) with
a temperature at the end of the system to ensure that they have the proper temperature through-
out the full system. In addition, manual titration of the chemical is a necessary, part to ensure
that it is at the proper concentration.
On most of them that have been built in the last ten years, they have a conductivity meter but
on some it is only for reading and not controlling. On others they use that conductivity to add
chemicals and to hold the timer if the concentration is low on start up. Not all of them use them
to add more chemicals if the concentration drops. The author recommends a conductivity meter
if the OEM can do it.
Manual cleaning of the outside of the equipment is generally not done during the CIP but prior
to it and should be done on a regular frequency. During the CIP, this is the best time to walk the
system and check for leaks so that they can be repaired prior to SIP.
12.4.2.2 Sterile Tank
The concentration will start at 1.5–2.5% active caustic and will need to be adjusted up or down
based on your product mix. Also, this will change depending on your chemical. If it is commodity
caustic, it may go up, and if it is a built caustic cleaner with additives, it may go down.
The concentration in the sterile tank is lower than in a UHT system due to absence of heating
in the tank. Acid will start at 0.7–1.5% and will need to adjust up or down based on your product
and water makeup.
It is important to do an acid step on a sterile tank. Most sterile tanks are sterilized using
steam and if you are not using acid over a period, the tank will start turning slightly brown. If the
culinary steam filters fail or are not maintained, this can increase this issue.
12.4.2.3 Fillers
On fillers, the concentration will start at 1–2% active caustic and will need to be adjusted up or
down based on your product mix. Also, this will change depending on your chemical. If it is com-
modity caustic, it may go up, and if it is a built caustic cleaner with additives, it may go down.
The acid will start at 0.7–1.5% and will need to adjust up or down based on your product and
water makeup.
Figure 12.4 Quick analysis to determine when to stop alkali wash in the cleaning cycle. In this illustra-
tion, the sweet spot is 40 minutes, to stop the cleaning cycle. Any cycle time exceeding 40–45 minutes is
wasteful and counterproductive.
12.4.3 Time
As you determine your times, it is important to remember that there is a limit to the time and the
effectiveness of cleaning.
You want the right amount of time needed to ensure that the chemical can do its job. Normally
you would like to see two to three passes of the chemical through the system. Too long of a time
may cause you to redeposit the soils back onto the equipment. With the test that was performed
below, samples were taken every 5 minutes to determine when it stops removing solids from the
equipment (Figure 12.4).
You can see at around 35–45 minutes the level of suspended solids did not increase, so adding
more time will not take any more solids out, so it is time to rinse.
• Actual times need to be established during the validation of the CIP on each piece of
equipment.
12.4.4
Temperature for Cleaning UHT Systems
This factor can be based on the capability of the chemical and the type of product you are run-
ning. When cleaning aseptic or ESL equipment, it is strongly recommended that you do not use chlo-
rine or a chlorinated product. This equipment will usually clean at temperatures that will depend
on the OEM and may vary from 185°F to 295°F.
There are different schools of thought on what is the best temperature to clean UHT process-
ing equipment. Depending on OEM, the caustic temperature will vary from 185°F to 295°F. When
using a high temperature, it is generally the first caustic that is at a higher temperature and is
used to remove the outer layers of fouling. The second caustic is generally around 185°F, and the
acid should be between 150°F and 160°F (Tables 12.1 and 12.2).
TABLE 12.1 EXAMPLE OF A SINGLE CAUSTIC WASH USED FOR CLEANING A UHT STERILIZER
PRODUCING THIN VISCOSITY AND LOWER SOLIDS PRODUCT (MILK)
UHT Cleaning Single Caustic
Phase Chemical Concentration Temperature Time Flow
Pre- Water Not checked 70°–100°F *7 minutes ****1.5 times the
rinse flow of maximum
production
Wash **Caustic 2–3% Active caustic 185°F *45 minutes ****1.5 times the
NaOH or flow of maximum
KOH production
Rinse Water 6.1–7.8 pH 120° F *15 minutes ****1.5 times the
flow of maximum
production
Wash Phosphoric/ ***0.7–1.5% 150°–160°F *25 minutes ****1.5 times the
nitric flow of maximum
blend production
Rinse Water 6.1–7.8 pH Ambient *15 minutes ****1.5 times the
flow of maximum
production
*Time may need to be adjusted depending on validation results.
**Chemical restrictions may apply based on local requirements and adjusted based on validation.
***Acid may need to adjust based on water conditions.
*****Flow rate needs to be as fast as possible and as a minimum 30% above maximum production flow rate.
• Temperatures for cleaning sterile tank

• Most sterile tanks will clean at these temperatures
– Caustic (non-chlorinated) 175–185°F
– Acid 140–155°F
• Temperatures for cleaning fillers
• Caustic (non-chlorinated) 160–175°F
• Acid 140–155°F
12.4.5 For Sterile Tanks

The flow for the sterile tank during CIP is going to be controlled by the flow needed for the spray
balls. This flow is very important to know if it is too high or too low for the spray balls as it will
not clean the tank walls or agitators.
Most (not all) sterile tanks use air pressure to return the solution back to the CIP room. If
this air pressure is too high, you will blow a lot of air into the lines causing conductivity issues
as well as damage to lines due to the surges of water and air. If it is too low, the level will build in
the tank. The OEM will need to spend time to get this correct on start up. There are some that are
putting in a CIP return pump at the tank, by means of a flow panel, so it can be out of the system
during sterilization and production. This makes balancing the system easier as well as more
consistent during the CIP (Table 12.3).
TABLE 12.2 UHT CLEANING DOUBLE CAUSTIC FOR PRODUCING PRODUCTS WITH THICKER
VISCOSITY AND HIGHER SOLIDS (SUCH AS HIGH-PROTEIN ENERGY DRINK)
UHT Cleaning Double Caustic
Pre- Water Not checked 70°–100°F *7 Production flow
rinse minutes rates maybe
10 gpm higher
Wash **Caustic 2–3% Active 285°–290°F *25 Production flow
NaOH or caustic or minutes rates maybe
KOH 185°F (depending 10 gpm higher (if
on OEM) lower temperature
go with higher
flow)
Rinse Water 7.1–8.5 pH 120°F *7 ****1.5 times the
minutes flow of maximum
production
Wash **Caustic 2–3% Active 185°F *45 ****1.5 times the
NaOH or caustic minutes flow of maximum
KOH production
Rinse Water 6.1–7.8 pH 120°F *15 ****1.5 times the
production
Wash Phosphoric/ ***0.7–1.5% 150°–160°F *25 ****1.5 times the
Nitric blend minutes flow of maximum
production
Rinse Water 6.1–7.8 pH Ambient *15 ****1.5 times the
production
*Times may need to be adjusted depending on validation results.
*****Flow rate needs to be as fast as possible and as a minimum 30% above maximum production flow
rate.
12.4.6 For Fillers
The flow necessary to do the internal and external CIP of a filler is going to be set by the OEM. It
is important that this flow can be met and sustained through the CIP. Many fillers come with the
CIP system as part of the filler and others will require CIP be sent from a CIP skid.
12.4.6.1 For ESL Fillers

The internal cleaning for all the fillers ESL or aseptic is going to be similar. On some of these fill-
ers, they will have to disassemble equipment and hand-clean and/or clean in a COP tank. Some
of the items that will have to be hand cleaned are listed below:
TABLE 12.3 TYPICAL WASH USED FOR STERILE SURGE TANK

Sterile Tank Full Clean
Air
Phase Chemical Concentration Temperature Time Flow Pressure
Rinse Water Not checked 80°–100° F *7 Based 23–38 PSI
minutes on
spray
balls
Wash **Caustic 1.5–2.5% Active 175°F *30 Based 23–38 PSI
NaOH or caustic minutes on
KOH spray
balls
Rinse Water 6.1–7.8 pH 120°F *15 Based 23–38 PSI
minutes on
spray
balls
Wash Phosphoric/ ***0.7–1.5% 150°–160°F *20 Based 23–38 PSI
nitric blend minutes on
spray
balls
Rinse Water 6.1–7.8 pH Ambient *15 Based 23–38 PSI
minutes on
spray
balls
*Time may need to adjust during validation and may not include the time to pulse valves in steam
barriers.
** Chemical restrictions may apply based on local requirements and adjusted based on validation.
*** Acid may need to adjust based on water conditions.
****Air pressure to be set at commission based on distance and no CIP return pump.
• You will have to disassemble the fill nozzles and screen or filter packs.
• You will then send them to an area so that they can autoclave them and some compa-
nies will have installed a second set (to rotate the first one with) which has already been
cleaned and autoclaved. These are installed after CIP of the filler prior to being steril-
ized for production.
• The rest of the carton path through the machine must be hand-scrubbed and
sanitized.
• There may be other items that need to be disassembled and hand-cleaned. These instruc-
tions will come from the OEM (Table 12.4).
As you might have observed, on the equipment we listed above, we do not have a sanitizer step.
This equipment is going to be sterilized so that we do not need to do a sanitizer.
• On some of the ESL equipment, it will get a sanitizer used on it as a step to help with the
sanitizing of the equipment later getting it ready for production.
TABLE 12.4 TYPICAL INTERNAL WASH FOR DOWNSTREAM FILLERS—ASEPTIC AND ESL
Filler Internal CIP
Pre-rinse Water Not checked 70°–100°F *7 minutes Set by OEM
Wash **Caustic 1–2% Active caustic 165°F *35 minutes Set by OEM
NaOH or KOH
Rinse Water 6.1–7.8 pH 120°F *15 minutes Set by OEM
Wash Phosphoric/ ***0.5–1.5% 150°–160°F *15 minutes Set by OEM
nitric blend
Rinse Water 6.1–7.8 pH Ambient *15 minutes * Set by OEM
*Time may need to be adjusted depending on validation results.
12.4.7 Pulsing of Valves
Most of these systems will have steam barriers, valve clusters, and individual valves that
require pulsing. Valve pulsing allows both sides of the seat and the stem to be properly
cleaned. Many OEM will pulse the valves throughout the program and that is okay. Just
watch the CIP system to determine if this is causing extra time due to the pulsing (the times
may need to be adjusted).
If they pulse steam barrier valves during the cycle, this can lose concentration of chemical
and increase CIP as the chemical must be replaced. It may cause delays due to freshwater being
added and this will cause a temperature fluctuation that could cause a hold on the timer.
To avoid delays in the CIP, one practice that is being used is that at the end of each phase or
cycle, they will pause the timer and do all the valve pulsing. This allows for more consistent CIP
times and the valves can be pulsed as the need may be. The cleaning of these valves during the
pulsing requires that they pulse long enough, and enough times, at the correct time to clean the
burnt product off them.
This sequence for on/off time must be validated at the start up or commission of the machine
and is rechecked on a frequency to ensure it is working. I would recommend it is checked at least
every quarter. Changing temperatures, products, or mechanical changes will require it to be
revalidated.
We have discussed the four factors that are involved in cleaning a system, and if that was all
that was needed, it would be very easy to clean. But to clean a processor and get it cleaned there
are other factors that will come into play. We will lay out some of the issues, but it is important to
understand that every UHT processor at every plant will be different due to some of the reasons
discussed below:
Design: A system that is not properly designed and tested may not clean and every time a
change is made in the system, it may impact how it cleans. The ability to inspect areas to ensure
proper cleaning is important.
Water: The water used in every plant is different due to the water makeup and local con-
ditions. If you are using untreated water (well or city), the minerals that are in this water
will affect the effectiveness of the chemicals and may require the addition of additives to
condition the water so that the chemicals can do their job. Hard water if not properly han-
dled will leave a buildup on the stainless steel, it will make it look dull and may cause stain-
ing. Having a regular water analysis done will help to understand what is happening. Where
possible, using treated water (soft water, RO, or Nano) will help reduce or eliminate these
problems. High levels of chlorine in your water system can also contribute to the staining
and possible pitting of equipment.
The type of product: Milk, juice, plant-based, high protein are examples and each one may
require a different concentration of chemicals to clean. If your system only has one CIP program,
then it needs to be set for your hardest product. If you add a new product, then you should do a
CIP validation after that product is run to test if the equipment is becoming clean.
12.4.8 Ingredients
The ingredients of a product can change how a system needs to be cleaned. Stabilizer overuse,
improperly blended (creating fisheyes, pockets of improperly hydrated product), or the type of
stabilizer may cause more fouling and “burn on” in the system. They may also lead to micro-hits
in your finished product due to the inability to sterilize the product that is not blended correctly.
Titanium dioxide when used is extremely hard to remove as it is heavy and unless you have
enough flow to carry it out, it will leave a white residue on the stainless steel. This is used as a
processing aid that will help make the product brighter (white). You may not even know it is in
your product as sometimes it is used to bind the stabilizer and your stabilizer company may not
let you know this. If you cannot get the proper flow to help carry it out, then more aggressive
cleaning with chemicals designed to remove titanium dioxide will need to be used. (Your chemi-
cal supplier will need to help you with this and handle it on a case-to-case basis.)
Proteins: As products come out with higher protein, it means it needs to be validated that the
chemicals and cleaning program that is being used will remove them. These types of products
will cause fouling in the hold tube and in the preheater. As this fouling happens, it coats the
probes controlling the temperature, and you will see an increase in steam usage to compensate
for the fouling in the hold tube. This results in the product fouling even more onto the hold tube.
This is generally observed as the difference in the temperature from the beginning of the hold
tube and the end of the hold tube drifts apart. When you get over a 4°F difference between the
beginning and the end of the hold tube, this indicates that you need to act with an AIC to help
remove this layering.
Plant-based products create different cleaning issues and each one will need to be evaluated
and validated to ensure proper cleaning.
Temperature: The temperature on most products is determined by a Process Authority.
The high temperatures at which the product runs for aseptic and ESL create a different chal-
lenge compared to an HTST. What the temperature does to different ingredients will chal-
lenge how we CIP. One of the problems is to maintain longer runs when the system is slowed
down, but the temperature is not or cannot be reduced. This causes more “burn on” in the
hold tube which then creates another very difficult layer of soil that must be removed. If this
is not completely removed during CIP, it creates a layer that cannot be sterilized. As you run,
the old product may sluff off and reveal an unsterilized area which will then contaminate
the product you are running.
During CIP, it is important to watch the different temperature probes to ensure you are get-
ting the temperature and time in all areas that you need for CIP. Work with your OEM and chemi-
cal supplier on what the temperatures in these different areas should be.
12.5 CLEAN-OUT-OF-PLACE (COP)
One piece of equipment that is underused to help in the overall cleaning and sanitization process
is the clean-out-of-place (COP) tank. The COP tank is used to clean small parts and equipment
that you are not able to CIP. It may include but is not limited to the following equipment:
• Fill tubes for batching tanks
• Buckets used to weigh ingredients
• Tools used to measure ingredients
• Parts of a filler that need to be hand-dissembled and cleaned
• Gaskets, or other rubber parts
• Clamps
• Short pipes and hoses (pipes and hoses may need to be hand-cleaned on the inside with
a brush prior to COP. Pipes and hoses over 3 feet should be evaluated to determine if
they are being cleaned completely).
Just like a regular CIP, it is important to keep allergen concerns and controls in place to prevent
any cross-contamination. In loading a COP tank, it is important to not overload as the mechani-
cal force is limited and you want to be sure all parts are receiving the most flow and mechanical
action that they can. COP can be accomplished by following the 11 steps given below.
1st step: Each part or piece of equipment needs to be rinsed to remove the easy-to-remove
product residue.
2nd step: Load all the parts and items to be cleaned into the tank, items that float or may
be pulled into a pump should be loaded into a perforated basket that has a perforated
lid on it and placed into the COP tank. If pipes are put into the COP tank, they need to be
shorter pieces. Pipe over 3-feet long may need to be brush-cleaned, on the inside, prior
to being put into the tank as they will not get enough flow through them to effectively
clean them.
3rd step: Fill the COP tank to a level to cover all the items that you have placed into the COP
tanks and above any spray bar lines in the tank.
4th step: Start the pump on the system to start it circulating. Check that you can see the
flow in the tank that is creating some turbulent action.
5th step: Add the chemical you are going to use at the level that your chemical representa-
tive suggests.
6th step: Heat the solutions to the required cleaning temperature. This temperature raise
can be controlled on new COP tanks, compared to older ones. It is important to monitor
this temperature to avoid overheating, and charts may be used to estimate the heating
time. If using an alkali, the temperature of the COP required would be between 150°F
and 160°F. For safety, you do not want this temperature above 180°F.
7th step: Let the above step run for 30 minutes.
8th step: Shut the heat off and turn the water on. During this step, you want to overfill the
COP tank to flush all the solids you have pulled off and that are in suspension to flow
over the top for the first 5 minutes of the rinse. This will help reduce the chance of the
solids you have removed from being redeposited onto your clean equipment.
9th step: After you have overfilled the COP tank for 5 minutes, shut the water off and drain
all the water out of the tank.
10th step: You now need to rinse off the chemical, so turn the rinse water on and let it fill the
COP tank up over the parts in the tank. Then leave the water on to keep the level above
12.7 Aseptic Intermediate Clean (AIC) 271
the parts start draining and rinsing until the chemicals have been removed. This will
generally take 7–10 minutes.
11th step: Shut the water off and let the parts drain. If you are not doing an acid step, then
you are finished; however, if you are going to do the acid step, then repeat from step 3 on
to only replace the alkali with acid and reduce the temperature to 140°F.
After the COP tank is empty and rinsed, then all parts need to be removed and either put back
into service or stored on a clean parts rack until needed. As parts are put back into service, each
part will need to be sanitized by hand prior to use. COP if properly used can save time and labor
on cleaning parts. It is not a storage place for parts after they are cleaned.
12.6 SIP (STERILIZATION-IN-PLACE)
SIP is step 3 in the process (see Figure 12.1), following preventive maintenance, cleaning, and
sanitization in this order. SIP should only be done on clean equipment; one cannot sterilize a dirty
piece of equipment.
SIP consists of three steps:
1. Heat the system up to the necessary temperature needed to consider it sterile, which
is >250°F.
2. Hold it at that temperature for the required time, which is 30 minutes. If the tempera-
ture drops below 250°F, then the timer must be restarted at “0,” after it is >250°F.
3. Cool down the areas of the equipment that do not need to remain above 250°F.
SIP must be performed on any piece of equipment that is going to come in contact with product
after the product has been sterilized. The method that is used can be steam, superheated water,
or chemical.
12.7 ASEPTIC INTERMEDIATE CLEAN (AIC)

Aseptic Intermediate Clean (AIC) is an intermediate flush or clean of the system under sterile
conditions. They are not as effective as a full CIP, but what they do is remove some of the outer
heavy layers of fouling so that you can continue production without needing to do full blown
CIP and SIP of the entire system. If they are done at proper intervals for the product you are run-
ning, it will help reduce the issues that occur at CIP. AIC generally takes 45 minutes to 1 hour,
compared to about 6 hours for a full CIP and SIP. They can be set up to do at regular intervals, but
it is important to remember that some products you may run will foul the system quicker than
others, so you need to identify them to help determine when an AIC is needed. Some places that
can help you determine this are the control valve for your steam or hot water, an increase in the
output is a sign of fouling. There is difference in temperatures from the beginning to the end of
the hold tube; the farther they are apart, the more fouling there is. AIC is normally done with just
caustic but in some circumstances, you may need to do an additional acid AIC, especially if you
have very hard water. The key is to add the chemical very slowly to not disrupt the temperature or
the flow (Table 12.5).
Another issue comes when a system loses sterility and to save time, they do not do a CIP
before they sterilize the equipment. This increases the burn that is already in the hold tube and
TABLE 12.5 TYPICAL ALKALI ASEPTIC INTERMEDIATE CLEAN (AIC) WASH FOR ALL UHT
STERILIZERS ON EXTENDED RUNS
UHT AIC Steps
Rinse Water Not checked At production 5 minutes **At production
temperatures flow rates
Wash *Caustic 2–3% Active At production 25 minutes **At production
NaOH or caustic temperatures flow rates
KOH
Rinse Water 6.1–7.8 pH At production 15 minutes **At production
temperatures flow rates
All temperatures, flows, and pressures must remain under sterile parameters.
* Chemical restrictions may apply based on local requirements and adjusted based on validation.
**Flow rates may be reduced by up to 5 gpm to prevent loss of sterility due to flow spike.
causes areas that normally do not see the hot product (like your cooling sections) to have prod-
uct residue in them that will burn on. This is an ineffective sterilization and could lead to major
micro-issues over time. Doing an AIC after sterilization does not remove the issues that have
been created, as an AIC does not have the effectiveness of a full CIP. It is strongly recommended
that if a product has been run or the system has been set for a long period of time (over 24 hours),
a full CIP should be performed prior to sterilization.
12.7.1 Concentration of Chemical
The concentration of the chemical should remain consistent throughout the step. What can
happen is that due to water added, valves pulsing, or other issues, the concentration is sig-
nificantly reduced during the step. Depending on the issue, this can happen quickly. As a
result, instead of a 30-minute wash at concentration, you only get 10–15 minutes at concen-
tration. On a direct system, it can happen from the addition of steam to the product, at the
flash vessel due to not controlling level and or pulsing of valves especially at steam barriers.
It is important to titrate your system not just at the beginning or middle of your cycle, but
at the end occasionally to ensure you are not losing concentration. Most UHT processors do
not have a probe for conductivity and as result a CIP can be run with little or no chemical.
Sterile tanks and fillers generally have a conductivity control. Just remember, conductivity
is a verification of titration.
Monitoring of the cleaning both internally and externally: During the CIP, it needs to be moni-
tored, it is not the time to push a button and forget. Knowing what the system is doing and verify-
ing will help ensure that it is properly cleaned.
12.7.2 Sterile Tanks
The sterile or storage tanks are generally cleaned from a CIP skid and this skid uses the return
temperature and the conductivity sensor to start the time in each step and to hold if they fall out
of range. If the tank does not use a CIP return pump but uses air pressure, the system can start
12.8 Validation and Verification 273
up if it has to pressurize the tank. Manual titration of the chemical is a necessary part to ensure
that it is at the proper concentration.
The system will generally incorporate throughout the wash special steps to pulse all the
valves that are being cleaned with this system. I have found that by putting this at the end of
each step, it saves time as the system does not continually add water to make up for what is
lost. You do the same number of pulses for the same time but less holds for low temperature
or conductivity.
Manually cleaning the outside of the equipment is generally not done during the CIP but
rather prior to it and should be done on a regular frequency. During the CIP, this is the best time
to walk the system and check for leaks so that they can be repaired prior to SIP.
12.7.3 Fillers
The program and the control for the CIP of the fillers is set up by the OEM. They generally are
holding and controlling by temperature and conductivity. Manual titration of the chemical is a
necessary part to ensure that it is at the proper concentration.
External cleaning. Most of the fillers have what is called a car wash for the external cleaning
(this is inside the enclosure but not the internal product contact areas). This will be used to help
clean the star wheels, outside of the filler bowl, and other areas. It will generally use a soft metal
foaming cleaner and will rinse it off as well. This does not mean you do not need to clean inside
manually as well as clean and check filters and screens. The manual scrubbing may be time-
consuming. But if it is not done, the level of contamination builds up and you can get issues,
especially around the cap or sealing area. This needs to be done every CIP.
12.8 VALIDATION AND VERIFICATION

12.8.1 Validation
Validation is the process we use to determine if a CIP or cleaning program is effective. Validation
is not a one time and done process. There are changes that will drive that a new validation be
performed.
• Validation should be done on any new equipment.
• Validation should be done on any modified equipment, and any replacement equipment
that is not like for like.
• Validation should be done on any program change of the CIP on the system.
• Validation should be done on every product or product group.
• Validation should be done when ingredients are changed or modified on any product
formulation.
After revalidation, document all changes made, and record all results.
Five steps in revalidation
• (1) The first step is to run through the program on water, checking to see if pumps are
turning the correct way, valves are pulsing when they are programed to, flow is going
where it is designed to. Instrumentation is working and there are no leaks or bad welds.
• (2) The second step is to run the program with the chemicals and checking the same as
in the first step.
• (3) The third step requires getting the equipment dirty (equipment should be run for a
normal cycle time before cleaning and validation.) Then run the CIP program and check
all items from the 1st step.
• (4) The fourth step starts at the conclusion of the CIP. You will need to open the equip-
ment to see effectiveness of the clean and check the following:
• Visual inspection
• ATP (adenosine triphosphate) will test for organic residue
• Doing micro-testing (standard plate count [SPC] is one method)
• Doing allergen testing if needed
• (5) The fifth step repeats the process starting at step 3 at least three times to check that
the CIP performs the same each time. If any failures, you will need to fix the reason for
the failure and then repeat the steps.
12.8.2 Verification
Verifications need to be done so that every CIP and CIP program is checked at least every year (if
no changes have happened). This is the process which is used to check that the cleaning is being
performed as and when it was validated. This process should happen a minimum yearly. If clean-
ing fails a verification, then you need to determine what may have caused the failure.
Verification uses visual, ATP, and CIP records to check and verify that the system is working,
this would include titration checks as well.
12.9 PASSIVATION
Modern food and pharmaceutical processing use equipment that are made up of stainless steel.
Stainless steel is preferred to maintain a high level of performance and to undergo minimum
corrosion. Passivation is an important surface treatment that contributes to the corrosion resis-
tance of stainless steel used for food-contact surfaces.
Stainless steel gets its corrosion resistance from a thin, durable layer of chromium oxide that
forms at the metal surface and gives stainless steel its characteristic “stainless quality.” The pas-
sive film on a stainless surface consists of a mixture of oxides of iron, chromium, and, if pres-
ent, molybdenum. The chromium oxide film will form on the metal (stainless steel air dries for
72 hours) if the stainless steel is clean and dry. Further exposure to air does not yield additional
corrosion protection.
Complete passivation cannot be achieved if product-contact surfaces are not clean or if they con-
tain surface defects including rust. The different oxides and their relation to passivation is not yet
fully understood.
The complete passivation process consists of mechanical cleaning, degreasing, inspec-
tion, the actual passivation by immersion or spraying, and rinsing. Passivation is done by
immersion or spraying, depending on the size of the piece, with a solution selected from
ASTM A 380. In addition to the standard nitric acid solution, there are a number of differ-
ent solutions appropriate for all grades of stainless steel, including 200, 300, and 400 series.
An oxidizing acid such as nitric acid, used for passivation, dissolves any high carbon tramp
steel and assures a uniform clean surface that results in the consistent formation of the
chromium oxide film.
12.9 Passivation 275
12.9.1 Passivation Process
12.9.1.1 Some Preliminary Considerations
Before we get into the passivation, we want to remind everyone that safety is the priority to
always keep in mind. So, any entry into the tank must be done by someone trained and certified
to do confined space entry. The lock out tag out program must be followed, and all PPE (personal
protective equipment) be used. Before passivation can start, it is important to know your water
makeup to ensure that chlorides are not above 75 ppm as chlorides can be very damaging to
stainless steel and it could affect the passivation process.
Passivation is a widely discussed topic and not always agreed upon how to do, what chemical
to use, and how often it needs to be done. I am laying out the passivation that I have found to be
most successful and if it is performed as it was designed, at the correct temperature and the cor-
rect concentration, it will not damage the equipment. Passivation is not a once and done type of
process, there are conditions that cause a passivation to have to be redone:
• Time. Over time and continuous use, the chromium oxide wears down
• Incorrect cleaning. Cleaning with the wrong chemical or the wrong temperature for a
chemical can damage the tank and will cause staining and rusting.
• Ingredients that are high in chlorides will attack the stainless steel and will have to be
treated.
• High-chloride products may require a more resilient stainless steel such as AL6N; there
are others as well and will need to be researched.
• Passivation is the process by which a stainless steel piece of equipment is treated with
an acid blend to help reduce staining, corrosion, and improve the life of the metal by
creating a thin lay of chromium oxide on the surface that helps protect the stainless
steel. This is accomplished by the circulation of a passivation acid then draining the
equipment and allowing it to air dry. It is during this drying time that the level of chro-
mium oxide is developed. It has been determined that 72 hours of dry time gives the
most successful layer.
12.9.1.2 Passivation Process
Let’s talk about how this process is done and what is required. I will be using information that
I have learned over the years. I will also be referencing some information from Ecolab®. For the
best success, please work with a competent chemical supplier to help guide you.
Passivation is usually done on Silos, Tanks, and other vessels. Before passivation can happen,
the equipment must be clean. Some of the problems you may face or described below:
• Rust. If rust is present, it must be removed either with a de-staining process (this may
take several tries to remove). If the rust is too deep in the metal, it may require buffing
to help to get it out.
• Stainless may have tramp iron in it from the manufacturing process.
• It could have oil that have been applied after process and prior to shipping to help pre-
vent the tramp metals from rusting during transportation.
• There may be polishing dust that is electrostatically charged to the metal.
• There may be adhesives from the protective film used by manufacturers.
Each of these items needs to be addressed and removed. The tramp metals should be dissolved
during the passivation process if the right passivation acid is used. The other items must be
removed prior to the passivation. To remove most of them, a caustic cleaner designed to clean
out these types of contaminants needs to be used. I have had good success with a product from
Ecolab® called Accomplish™ as it was designed for this purpose.
Removing the black polishing dust is a little more difficult as it is electrostatically charged to
the metal. To determine if you have this, take a white towel or white paper towel and wipe an area
inside the vessel. Then examine the towel under normal light outside of the vessel and you will
see the black dust if it is present. To remove it, you will need to clean the vessel with a quaternary
ammonium cleaner that will help break the charge so that it can be removed.
12.9.1.3 Cleaning and Passivation

The following is the order needed to be followed for the cleaning and then the passivation.
Remember it should be done under the direction of your chemical supplier and in conjunction with
your OEM recommendations.
• First determine if you have black polishing dust (this is explained in the paragraph
before this section. If you have black polishing dust, then the quaternary ammo-
nium circulation will need to be done first. Use under the direction of your chemi-
cal supplier and in conjunction with your OEM recommendations. The cleaning
to remove the black polishing dust is generally done at temperatures below 100°F;
concentrations of 3–4% by volume; circulate 10–15 minutes. Also be alert as to how
this will impact your wastewater. You will need to know what methods will be used to
address the disposal of the chemical.
• After the quaternary ammonium circulation, rinse and drain.
• Then use a caustic cleaner like the Ecolab® Accomplish™ and circulate. Use under the
direction of your chemical supplier and in conjunction with your OEM recommenda-
tions. Also be alert as to how this will impact your wastewater and what methods will
need to be addressed for the disposal of the chemical. The temperature of the caustic is
150°F; Concentration 10% by volume; Circulate 1 hour
• After the final rinse, investigate the tank to see if it is clean. One sign that it is clean is
that there will be no water beads. If water beads are present, then the cleaning needs to
be redone.
• After the Accomplish™ has been rinsed and drained, use towel method to check that
the polishing dust has been removed. If it has and the vessel looks clean, you may con-
tinue to the passivation.
• If not, repeat the process starting with the quaternary ammonium until it is clean.
There is another method using citric acid. You need to realize that the citric acid may not dissolve
the tramp metal that may be in the tank. In addition, the citric acid will need to be used with
EDTA which will help suspend the particles but may not dissolve them and they could redeposit.
In addition, it will require longer circulation.
Another commonly used passivation process consists of using passivation acid from Ecolab®,
and this is a nitric/phosphoric blend. The nitric will dissolve the tramp metal during the process.
Which chemical you use will be up to you, your chemical supplier with input from your OEM.
Recommendations from Ecolab® if using their chemical:
• Temperature 140°F; concentration 50% by volume of passivation acid; circulate once at
temperature and concentration for 1 hour; rinse; drain; let dry for 72 hours.
• This process of passivation on a clean vessel will give you the maximum chromium
oxide formation on your stainless steel.
12.10 Maintenance 277
The ASTM International has procedures for the testing of chromium oxide. They are not gener-
ally used in the food industry due to the cost and the chemicals that they use.
The testing for iron left in the tank is a test that you can do and is an indication that the pas-
sivation was successful, remember this is qualitative not quantitative.
12.10 MAINTENANCE
The maintenance of the equipment is one of the key factors to ensure that the cleaning, sanitiz-
ing, and the production of products at the facility is consistent batch to batch.
Best-in-class maintenance program can be implemented by a two-stair step process: (1) pre-
ventive maintenance and (2) breakdown maintenance. A well-planned and executed mainte-
nance program is one of the easiest and best ways to increase uptime by reducing unplanned
downtimes. Following a preventive maintenance (PM) program can also help reduce contamina-
tion, because gaskets, O-rings, and pump seals are changed before they fail and as a result do not
become a harborage or ingress into the system.
A maintenance program includes a proper inventory and inventory control to ensure parts are
on hand when needed. The OEM will generally give a list of suggested parts to keep on hand as
well. Remember that if you do not have the correct part on hand, this could cost an extended
downtime while sourcing the correct part either locally/domestically or internationally.
12.10.1 Preventive Maintenance
Preventive maintenance is a plan that creates a plan for inspection, by which equipment is
rebuilt or replaced as needed. A plan is set up for each piece of equipment to be checked on a
frequency that is established to be repaired before it fails. The plan should be mapped out and
cover every gasket, O-rings, valve, pump, and instruments in the system. It should also include
a calibration program for all instruments. To start with, the frequency is set for a short interval
and then the equipment is evaluated. You can extend the time as you do an evaluation and if no
evidence of failure is seen. You would shorten the time if the equipment failed before the next
inspection time.
Each piece of equipment needs to be on a PM program (these are some items that may be
included on a PM program):
• Gaskets for each area will be different based on location.

• This includes plate gaskets.
• It includes the O-rings on the fillers and the proper frequency to replace them.
• Pressure gauges checked for cracks are missing stainless cover.
• Instruments, are they working as designed?
• Valves
• Back pressure valves
• Pumps
• Spray balls
• Steam traps
• Preventive maintenance includes calibration of all instruments to ensure they are work-
ing and reading correctly.
12.10.2 Breakdown Maintenance
Breakdown maintenance is where equipment is allowed to fail before fixing. This type of mainte-
nance is generally more expensive and time-consuming than preventive maintenance.
This leads to what is sometimes called firefighting, which is fix the problem after it fails
instead of preventing the problem before it occurs.
Several limitations of relying on breakdown maintenance are as follows:
• Generally, it happens during production resulting in lost product and production time.
• Increased risk of contamination due to leaking areas in the product area where it can affect
the product, for example, gaskets, pump seals, pressure gauges, and pressure sensors.
• On pressure gauges/sensors may get a crack in the diaphragm or the bottom foil may
come off. This can lead to product contamination and may not be discovered soon
enough, so it can be fixed, or replaced. As a result, large quantities of product can be
affected and put on hold for testing and disposition.
• There is a risk you do not have the correct part on hand requiring extended down time
or using non-standard replacement part that may or may not fix the problem or void the
warranty with the OEM.
12.11 CHANGE CONTROL MANAGEMENT PROGRAM (CCM-P)

Every company should have a Change Control Management Program Council that can review all
changes and their risk versus benefit, including unintended collateral consequences. This pro-
gram documents and tracks all changes during and after implementation. It also sets up a clear
path that all changes must go through the CCMP Council and all departments involved and/or
impacted by this change. A change control procedure lays out a planned response to any change
or update; below are some examples of what a change control should have done on it.
12.11.1 Program Change
Any time any program is changed, it needs to be validated as to how the change impacted the
operation, especially the cleaning of the equipment. This includes but not limited to:
• Increasing or decreasing timed steps.
• Changing of valve pulsing.
• Sequence of the steps.
• Removing or adding of a step.
• When any of these changes are made, then you need to do a new validation that it is still
cleaning or running to the necessary standard and expectation.
• Part replacement if the part you changed is not like for like. If you change a part and you
have to change it with a different part that is not exactly the same, you need to evaluate
that change:
• If you change a pump, it must be of the same horsepower, the same RPM, the same
impellor size, the same inlet and outlet. If any of these changes, then you need to
revalidate the system.
• If you change a valve and the stroke length is the same, does it function exactly like
the one replaced, if not you need to validate.
12.12 Environmental Cleaning 279
12.11.2 Ingredient Change
Sometimes it is felt that an ingredient can be substituted or replaced with another without vali-
dation. This may have profound impact on product itself, process, package, and stability of prod-
uct during its shelf life and life cycle.
• Ingredients are changed for cost-saving. The new ingredient should be analyzed for all
risks—microbiological, allergenicity, foreign matter, and chemical contaminants.
• R&D Product Development should make prototypes with “old and new” ingredients
to understand the performance while batching, processing, and finished product, and
shelf life stability. Any shifts in viscosity, pH, TSS should be reviewed carefully.
12.11.3 Procedure Change
All new or modified procedures when implemented should be tracked and proven out:
• If an SSOP is changed, you need to validate that you are getting the same level or higher
effectiveness than with the old one. Changing an SSOP without a validation process for
saving time or money can be a recipe for disaster.
• If you change any SSOP or a SOP before it becomes the new standard, it must be validated.
12.11.4
Chemical Change
The control and use of chemicals are critical to the cleaning of the equipment and the safety of
the employees. Where possible, the number and types of chemical need to be limited to what is
necessary. There must be a solid policy in the filling of bulk systems to prevent wrong chemicals
in the tank. Validation of every chemical line with water before chemical to ensure that is going
where it was designed to go and not leaking.
If any chemical is changed. it is extremely important to have a change control so that you can
ensure the old chemical is removed, all lines completed rinsed and tested prior to the new chemi-
cal being introduced. All lines and containers clearly marked and if chemical changed all labels,
change to match the chemical.
12.12 ENVIRONMENTAL CLEANING
Environmental cleaning should be part of each plants Master Sanitation Program that is tracked.
12.12.1 Environmental Monitoring
Every plant needs an environmental monitoring program. This program will not only cover the
inspection of an area but dictate what should be happening in that area. If the plant is dealing
with allergens, then this plan for environmental monitoring and cleaning becomes extremely
crucial as it can allow cross-contamination if it is not followed.
Environmental is not just the air quality, it is the condition and use of every area of the plant.
This includes a routine plan where different areas are swabbed and checked at a predetermined
time interval to ensure that each area is getting the attention it should. The check should include
swabbing for micro, visual, and smell.
• This includes the walls and floors.

• The frequency of the cleaning of walls and floors.
• The cleaning and checking of anchorage points on all equipment to prevent any har-
borage areas.
• This would include controlling the foot traffic through sensitive areas.
• Cleaning of the drains to prevent buildup of bacteria.
• The ceiling area, lights, and overhead pipes
Some of the most overlooked and least cleaned areas in the plant or ceiling area, lights, and
overhead pipes. These areas get a lot of moisture, and dust buildup and as a result become high
areas of growth. What is forgotten is that if these areas are left unattended, this layer of dust and
moisture build up and then it will flake or drip off and fall into product, footpaths, and become a
source of contamination. These need to be part of a Master Sanitation List that is followed, and
each area cleaned based on the conditions in that area.
12.12.2 Air Quality
The air quality is not only the air that is brought into the facility but is a factor especially on fill-
ers and filler rooms. The plant must have a plan where the air quality is tested in every room of
the plant on at least a quarterly basis and in some it may be daily due to the sensitive nature of
the area.
A lot of the fillers in ESL use HEPA filters for the air that is going into the machine. This air
must meet the standard the OEM set up for their filler. This air must be checked on a frequent
basis to ensure you are getting the proper filtration of the air used for preventing contamination
of the product prior to the package being sealed. Several factors will go into the life of these filters
and will dictate how often to change them.
• The construction of the room
• The condition of the room
• The humidity in the room
• The foot traffic in the room
• The personal hygiene of the personals in the room
• Recommendation by OEM for replacement interval or cycles of presterilization–for
example, 25 cycles of use
12.12.3 Zoning and Segregation

It is encouraged that areas of the plant be zoned or segregated based on the sensitivity of the
room and the area. When you zone or segregate areas, you must also control access into these
areas, limit foot traffic into each area to only those who need to be in them.
• Raw receiving should be separated from pasteurized. Employees working in raw should
not go into any other area.
• Blending separated from processing.
• Fillers should be separated from other areas.
• Garbage and waste areas isolated and controlled.
• Allergens need to be controlled all the way from receiving until they leave the plant.
12.14 Definitions 281
12.12.4 Other Items
One of the concerns we want to address is that the cleaning of the plants and equipment require
a large amount of water and chemicals. The environment is all our responsibilities, and each
facility needs to look at every area of the plant to be sure they are doing what they can. It should
include audits by their chemical vendors/partners and or outside parties to help identify and
help the companies to reach these sustainable goals.
The control of the chemicals being disposed of needs to be addressed. Only using the amount
of chemical that is needed and not overusing chemicals is very important. Many companies have
their own wastewater systems that will ensure that the water being rejected from the plant is
within the specifications of the location/municipality they are in. This may require a tank to buf-
fer pH prior to it being sent into the waste stream.
The conservation of water should always be looked at. This requires looking at rinse times to
ensure that they are correct and not running excess water to the waste system. It requires that
equipment be run according to the OEM to ensure that things like pump seals are being con-
trolled and shut off when not in use.
12.13 SUMMARY
Cleaning and sanitization procedures must be considered as an integral part of food production.
No matter how well the production plant may be designed, if cleaning and sanitization are not
possible or not done properly, it is impossible to produce high-quality and safe products con-
sistently. Cleaning and sanitization are intertwined with production, and they are inseparable.
Cleaning and sanitization are one of the most important aspects of food manufacturing. This
has been made amply clear by announcements of food recalls stemming from contamination
with bacteria and foreign matter.
Cleaning and sanitization of aseptic processing and packaging unit operations is complex,
and should be handled with care, and with commitment with top-down mandate. Case count is
important. But “quality case count” is much more important, as it is salable product impacting
company’s bottom line.
There is reawakening of the importance of sanitation personnel and their impact on qual-
ity of food produced. Sanitation personnel can make or break a sanitation program. A plant
can have the best systems, controls, and products, but if the sanitation job is done poorly, there
could be problems. It is important that the sanitation personnel in the plant have the same skills,
knowledge, and performance objectives as the middle and top management to get the job done.
Continual education, training, and seminar at the plant level is imperative for production of
high-quality safe products.
12.14 DEFINITIONS
Breakdown maintenance: Breakdown maintenance, sometimes called firefighting,
means that you run equipment until it fails and then fix or replace when that happens.
This usually causes unplanned down time and is generally more expensive than preven-
tive maintenance.
CIP (clean-in-place): Circulating a cleaning solution through pipelines and large equip-
ment using a system of pumps and sprays to automatically clean these systems. Some
hand work is required.
Cleaning: Cleaning is using, flow (mechanical force), chemical concentration, time, and
temperature to remove soil from the surface of the equipment. It can be done manually
or using an automated cleaning system. It removes all traces of fats, solid materials, and
product or other residues from equipment and other surfaces.
COP (clean-out-of-place): Usually done in a long rectangular sink, 1.5–2 feet deep and 1.5
feet wide, filled with hot soapy water circulated in the tank or sink by a pump mounted
to the tank’s or sink’s base or by rapidly bubbling air through the water. Hand-cleaning
is done first for parts in a COP tank or sink.
Fisheyes: Fisheyes in a product represents product that is not mixed correctly; it has a
wet outer surface and on the inside a pocket of dry powders that heat will not be able to
penetrate.
Fouling: Fouling is the process that happens on the metal surfaces, especially the process-
ing equipment, caused by product sticking or being burnt to the metal. May be called
“Burn On.”
Intermittent clean-up: Intermittent clean-up is sometimes called an AIC (aseptic inter-
mediate clean) or short cleans for the equipment under sterile conditions to remove the
heavy soils for increased production time.
Potable water: Water that is clean and safe to drink.
Preventive maintenance: Preventive maintenance is a program that services, repairs,
and/or replaces equipment on a routine basis to help prevent unplanned breakdowns.
Will include but not limited to valves, pump, gaskets, and instruments.
Pre-sterilization: Pre-sterilization is the method used to sanitize or sterilize the equip-
ment to a point that it can produce products that will not spoil and be free of pathogens
for the shelf life of the product.
• ESL product (product stored under refrigeration) that will not spoil and be free of
pathogens for the shelf life of the product.
• Aseptic product (product that is stored without refrigeration) that will not spoil and
be free of pathogens for the shelf life of the product
Product contact surface: Any surface of a processing, filling, or packaging machine,
valves and piping, tank walls, conveyors, etc. that actually touches the product.
Sanitation: Sanitation is the process of cleaning and sanitizing the equipment to reduce or
eliminate the microbiological risks from the equipment.
Sanitizing: Chemical or heat treatment to kill germs. Includes rinsing, soaking, spray-
ing, or wiping with a sanitizing solution. All items to be sanitized must be thoroughly
cleaned. Sanitation may also be done by heat.
Water hardness – Concentration of sanitizers available for cleaning can be lowered due
to reaction with calcium and magnesium salts present in water. For rinsing, only soft
water (0–3.5 grains per gallon [gpg) or 0–60 ppm) of acceptable microbiological stan-
dards may be used. Water hardness will increase the sanitizer costs.
12.15 ACRONYMS
1. AIC – Aseptic intermediate clean
2. ASTM – Formally known as the American Society for Testing Materials
3. ATP—adenosine triphosphate
4. CDC – Center for disease control
References 283
5. CFR – Code of Federal Regulations

6. CIP – Cleaning-in-place
7. COP – Cleaning out place
8. EDTA – Ethylenediaminetetraacetic acid
9. ESL – Extended shelf life
10. GMP – Good Manufacture Procedure
11. HEPA – High-efficiency particulate air (filter)
12. HTST – high temperature short time
13. OEM – Original equipment manufacturer
14. PPE – personal protective equipment
15. SIP – Sterilization-in-place, some will call it sterilization-in-progress
16. SOP – Standard Operation Procedure
17. SPC – standard plate count
18. SSOP – Sanitation Standard Operation Procedure
19. UHP – Ultra-high pressure
20. UHT – Ultra-high Temperature
REFERENCES
Anonymous. 1994. Cleaning and descaling stainless steel parts, equipment and systems. ASTM A 380.94.
American Society for Testing and Materials (ASTM), PA. ASTM. www.astm.org
Centers for Disease Control and Prevention (CDC). 2021. List of Selected Multistate Foodborne Outbreak
Investigations. Burden of Foodborne Illness: Findings | Estimates of Foodborne Illness. Atlanta, Georgia,
USA: Centers for Disease Control and Prevention CDC.
Ecolab® (For more knowledge or excess to these documents contact Ecolab®).
a. Advisor Documents for Passivation of Stainless Steel
b. Advisor Documents for the Removal of Black Polishing Dust
IAMFES Pocket Guide to Dairy Sanitation. 1996 Des Moines, IA: International Association of Milk, Food,
Environmental Sanitarians. Des Moines, Iowa.
Katsuyama, A.M. 1993. Principles of Food Processing Sanitation. 2nd edition. Washington, DC: The Food
Processors Insititute (FPI), National Food Processors Association.
Loncin, M., and Merson, R.L. 1979. Cleaning, disinfection, and rinsing, Chapter 10. In Food Engineering:
Principles and Selected Applications, 310–329. New York: Academic Press, Inc.
Troller, J.A. 1983. Sanitation in Food Processing. New York: Academic Press, Inc.

10.1201 9781003158653-14 Chapterpdf

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

10.1201 9781003158653-14 Chapterpdf

Uploaded by

Copyright:

Available Formats

Chapter 12

Cleaning and Sanitization for

DOI: 10.1201/9781003158653-14 255

12.9.1.2 Passivation Process 275

12.2 EQUIPMENT PREPARATION AND SET UP (EPSU)

Step 0: Preventive maintenance

12.4.1 Flow (Scrubbing or Mechanical Force to

• Temperatures for cleaning sterile tank

12.4.5 For Sterile Tanks

12.4.6.1 For ESL Fillers

TABLE 12.3 TYPICAL WASH USED FOR STERILE SURGE TANK

12.7 ASEPTIC INTERMEDIATE CLEAN (AIC)

12.8 VALIDATION AND VERIFICATION

12.9.1.3 Cleaning and Passivation

• Gaskets for each area will be different based on location.

12.11 CHANGE CONTROL MANAGEMENT PROGRAM (CCM-P)

• This includes the walls and floors.

12.12.3 Zoning and Segregation

5. CFR – Code of Federal Regulations

You might also like

10.1201 9781003158653-14 Chapterpdf

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

10.1201 9781003158653-14 Chapterpdf

Uploaded by

Copyright:

Available Formats

Chapter 12

Cleaning and Sanitization for

DOI: 10.1201/9781003158653-14 255

12.9.1.2 Passivation Process 275

12.2 EQUIPMENT PREPARATION AND SET UP (EPSU)

Step 0: Preventive maintenance

12.4.1 Flow (Scrubbing or Mechanical Force to

• Temperatures for cleaning sterile tank

12.4.5 For Sterile Tanks

12.4.6.1 For ESL Fillers

TABLE 12.3 TYPICAL WASH USED FOR STERILE SURGE TANK

12.7 ASEPTIC INTERMEDIATE CLEAN (AIC)

12.8 VALIDATION AND VERIFICATION

12.9.1.3 Cleaning and Passivation

• Gaskets for each area will be different based on location.

12.11 CHANGE CONTROL MANAGEMENT PROGRAM (CCM-P)

• This includes the walls and floors.

12.12.3 Zoning and Segregation

5. CFR – Code of Federal Regulations

You might also like

12.2 EQUIPMENT PREPARATION AND SET UP (EPSU)

12.4.1 Flow (Scrubbing or Mechanical Force to

12.4.5 For Sterile Tanks

12.4.6.1 For ESL Fillers

12.7 ASEPTIC INTERMEDIATE CLEAN (AIC)

12.8 VALIDATION AND VERIFICATION

12.9.1.3 Cleaning and Passivation

12.11 CHANGE CONTROL MANAGEMENT PROGRAM (CCM-P)

12.12.3 Zoning and Segregation