Preliminary

Technical Specification
For standalone CIP/SIP unit for ESL and aseptic
applications
October 3rd 2014

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1 Introduction .............................................................................................................................................. 3
2 General specification ............................................................................................................................. 4
2.1Chemicals ................................................................................................................................................. 4
2.2Temperatures ......................................................................................................................................... 4
2.3Flows / Velocity / Pressure ............................................................................................................... 4
2.4Timings ...................................................................................................................................................... 4
2.5Chemicals / Thermal ............................................................................................................................ 4
2.6Chemicals ................................................................................................................................................. 4
3 Application criteria ................................................................................................................................ 5
3.1Aseptic filling machines ...................................................................................................................... 5
3.2Ultra Clean and Extra Clean filling machines ............................................................................. 5
4 Directives & Standards ......................................................................................................................... 5
4.1CE-Conformity ........................................................................................................................................ 5
4.2Relevant standards ............................................................................................................................... 5
4.3Other technical standards .................................................................................................................. 6
4.4Relevant food manufacturing standards ...................................................................................... 6
5 Materials and components .................................................................................................................. 7
5.1Materials ................................................................................................................................................... 7
5.2Electrical- and electronic equipment ............................................................................................ 7
5.3Pneumatic equipment ......................................................................................................................... 8
5.4Process- and control valves............................................................................................................... 8
5.5Filters ......................................................................................................................................................... 8
5.6Colour coding on piping...................................................................................................................... 8
5.7Lifetime and maintenance ................................................................................................................. 9
6 CIP unit supplies and utilities ............................................................................................................ 9
6.1Electric power ........................................................................................................................................ 9
6.2Compressed air ...................................................................................................................................... 9
6.3Water.......................................................................................................................................................... 9
6.4Steam.......................................................................................................................................................... 9
6.5CIP/SIP liquids ....................................................................................................................................... 9
7 Detailed technical requirements for process units................................................................. 11
7.1Cleaning tank ....................................................................................................................................... 11
7.2Circulation pump ................................................................................................................................ 11
7.3Heat exchanger.................................................................................................................................... 11
7.4Chemicals supply unit ...................................................................................................................... 12
7.5Control of cleaning parameters .................................................................................................... 12

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 7.6Circulation circuit............................................................................................................................... 12
7.7Cleaning-In-Place (CIP) phase functionality ............................................................................ 13
7.8Sterilization-In-Place (SIP) phase functionality ..................................................................... 14
7.9Machine Utility Connections .......................................................................................................... 15
7.10 Electrical ..................................................................................................................................... 15
7.11 Controls....................................................................................................................................... 15
7.12 Software ...................................................................................................................................... 16
7.13 Machine Safety System ......................................................................................................... 16
7.14 Transportation and installation ........................................................................................ 16
7.15 Servicing and maintenance ................................................................................................. 16
8 Technical Documentation ................................................................................................................. 17
9 Technical Manuals ............................................................................................................................... 17

1 Introduction

This technical specification describes the criteria of a CIP / SIP stand-alone unit that will
be used together with ultraclean and aseptic carton filling applications.

When defining equipment as a CIP / SIP stand-alone unit for Ultraclean (UC) and aseptic
carton filling applications, the expectation is that the CIP / SIP stand-alone unit can fulfill
the following requirements

• Supply cleaning and sterilization solutions at correct temperature, concentration

and flow according to given specifications.
• Monitor and log parameters according to HACCP and other relevant legislation.
• Alarm if any deviation of critical cleaning parameters is outside defined range.
• Able to operate as both master and slave.

Some features considered important for a new CIP / SIP stand-alone unit:

- Minimized/optimal overall kit size

- Standardized designs and components
- Strong focus on low cost of ownership and cost of operation
- Operator interface with access to all required information such as critical control
points, technical documentation (manuals).
- Design modularity compliant with the different types of filling equipment
- No standalone cabinets other than the cabinets integrated in the kit to minimize
installation time
- Signal interface

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2 General specification

Ref ECS10027
2.1 Chemicals

2.2 Temperatures
CIP

Ref chapter 7.1.2 & 7.2.3

2.3 Flows / Velocity / Pressure

2.4 Timings

2.5 Chemicals / Thermal

2.5.1 Steam usage

SIP

2.5.2 Temperature

2.5.3 Flows

2.5.4 Timings

2.6 Chemicals
Disinfection exterior

2.7

2.8

2.9

2.10

2.11

2.12

2.13 Equipment dimensions

2.14 Required floor space

2.15 Noise emission

2.16 Material in contact with products

2.17 Material surface roughness

2.18

2.19

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3 Application criteria

3.1 Aseptic filling machines

3.2 Ultra Clean and Extra Clean filling machines

4 Directives & Standards

The machine must comply with all applicable EC Directives. The manufacturer is
responsible for selecting, applying and documenting appropriate standards in order to
comply with mandatory EC Directives.

4.1 CE-Conformity
4.1.1 Machine Directive 2006/42/EC
The Machine Directive 2006/42/EC provides the regulatory basis for the
harmonization of the essential health and safety requirements for machinery at
European Union level.

4.1.2 Electromagnetic Compatibility (EMC) Directive 2004/108/EC

4.1.3 Low Voltage Directive (LVD) 2006/95/EC

The CE Declaration of Conformity should contain the following statement: “The
protection aims of the low voltage directive 2006/95/EC were adhered to in
accordance with annex I, no. 1.5.1 of the Machinery Directive 2006/42/EC.”

4.1.4 Pressure Equipment Directive 97/23/EC

4.1.5 Simple Pressure Vessels Directive 2009/105/EC

4.1.6 Filling machine/ unit name plate

The name plate must be in English language and must contain a CE –mark.
Preferably designed according to Elopak drawing number 51015811. The full
name and address of the manufacturer must be stated on the name plate.

4.2 Relevant standards

For design and engineering, the most recent issues of relevant standards
published by the Official Journal of the European Union are to be used.

At release of this technical specification, publication dates for latest issues were as
follows:
• 28.11.2013 for the Machine Directive
• 23.10.2012 for the Electromagnetic Compatibility Directive

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 • 28.11.2013 for the Low Voltage Directive
• 04.05.2013 for the Pressure Equipment Directive
• 04.05.2013 Simple Pressure Vessels Directive

If new issues of relevant standards are published during the design and
engineering phase, these must be followed to the largest possible extent.

4.3 Other technical standards

4.3.1 ISO 11202:2010 Acoustics - Noise emitted by machinery and equipment.
Determination of emission sound pressure levels at a work station and at other
specified positions applying approximate environmental corrections

4.3.2 EHEDG doc 08 Hygienic Equipment Design Criteria

4.3.3 ISO 14159:2008 Safety of machinery. Hygiene requirements for the design of
machinery.

4.3.4 EN1672-2:2005 Food Processing Machinery – Basic Concepts – Part 2: Hygiene

Requirements.

4.3.5 (VDMA 2-2000)?

4.3.6 (VDMA 11-2006)?

4.4 Relevant food manufacturing standards

4.4.1 Codex Alimentarius

4.4.2 EU Food Directive 2002/72/EC

4.4.3 EU General Hygiene Requirements for all Food Business Operators 2004/852/EC

4.4.4 CFR 21 Title 113

4.4.5 IFS International Food Standard, release number 6.

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5 Materials and components

In general, all materials, semi-finished components and standard components

used must be readily available in Europe. All materials and components used
must comply with European standards and Directives.

5.1 Materials
5.1.1 Metal parts are primarily to be made from stainless steel. Stainless steel quality
selected must comply with the chemicals used for cleaning and sterilization of the
machine.

5.1.2 Metal parts in direct contact with product and cleaning- and sterilization
solutions must be made from AISI304L or 316.

5.1.3 Machine parts which require use of other metals must either be inherently
corrosion resistant to cleaning chemicals or be treated with suitable coatings.

5.1.4 Machine parts from polymer or elastomer materials must comply with relevant
Directives. Certificates of compliance must be included in the machine
documentation.

5.1.5 Parts subjected to heat must be resistant to the thermic conditions, also in
combination with chemicals used.

5.2 Electrical- and electronic equipment

5.2.1 Inductive sensors must be from known, international suppliers, and suited for the
intended use. 4-20mA.

5.2.2 Optical sensors for measuring peracetic acid concentration must be from Optek.

5.2.3 Plug connectors M12 to be must be from known, international suppliers. M12
connectors can be omitted if the defective component can be replaced and
reconnected in less than 10 minutes.

5.2.4 Sensors to be connected to the nearest terminal located in cable ducts. No bus
terminals must be located in areas exposed to cleaning chemicals, fumes from
chemicals or pressurized water.

5.2.5 All electrical- and electronic components must operate within the temperature
range specified by the component supplier.

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5.3 Pneumatic equipment
5.3.1 Suppliers of pneumatic components are SMC, Festo and Rexroth. Other pneumatic
component suppliers may be accepted if necessary in order to secure correct
operation or limit maintenance cost of the CIP unit.
5.3.2 All pneumatic components must operate within temperatures, humidity and
exposure to chemicals as specified by the supplier.
5.3.3 Diameter of pneumatic piping and tubing must be in metric sizes.
5.3.4 Tubing and tubing connectors must be resistant to heat and chemicals and be
approved for use in the food industry.
5.3.5 Tubing connectors to be made from heat- and chemical resistant metal.
5.4 Process- and control valves
5.4.1 All valves must be of hygienic design, all suited for the intended use.

5.4.2 All aseptic valves must have position control devices.

5.5 Filters
5.5.1 Filter cartridges and –housings from PALL.

5.6 Colour coding on piping

5.6.1 For stainless steel pipes, no colour coding is required

5.6.2 Water - Green

5.6.3 Air - Blue

5.6.4 Steam - Red

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5.7 Lifetime and maintenance
5.7.1 Expected lifetime and intervals between preventative maintenance (PMP) must
be specified for each component

6 CIP unit supplies and utilities

6.1 Electric power
6.1.1 Power supply 400V AC, 3 Phases + N (fully loadable) + PE

6.1.2 Voltage fluctuation ± 10%

6.1.3 Frequency 50 Hz

6.2 Compressed air

6.2.1 Quality of compressed air supplied to the filling machine (including auxiliary
equipement such as CIP unit) in accordance with ISO 8573-1:2010 Compressed
air. Part 1: Contaminants and purity classes.

6.2.2 Supply pressure 600-700 kPa.

6.2.3 Maximum particle size 20µm (Class 4).

6.2.4 Maximum particle content 25 mg/m3.

6.2.5 Dew point 2°C (Class 3).

6.2.6 Maximum oil content 0.01mg/m3 (Class 1)

6.3 Water
6.3.1 Potable water according to standard Council Directive 98/83/EC

6.3.2 Supply pressure 300-600 kPa.

6.3.3 Temperature 5-20°C (ambient).

6.4 Steam
6.4.1 Supply inlet temperature 132°C ± 4°C corresponding to a supply pressure of 190
kPa.

6.4.2 Supply pressure maximum fluctuation ±30 kPa

6.5 CIP/SIP liquids

6.5.1 Caustic concentration maximum 3.0 % (NaOH/KOH). Dosing pump and supply
pipe/tube able to withstand concentrated caustic, <50% (NaOH/KOH)

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6.5.2 Acid concentration maximum 2.0% (NH3). Dosing pump and supply pipe/tube
able to withstand concentrated acid, <50% (NH3)

6.5.3 Peracetic acid concentration maximum 2200 ppm. Dosing pump and supply
pipe/tube able to withstand concentrated peracetic acid based sterilization
chemicals, <150000 ppm.

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7 Detailed technical requirements for process units
7.1 Cleaning tank
7.1.1 Size of CIP cleaning tank should equal approximately 1,5 times the circuit volumes
(pipeline + FM). For general installations, working volume of 500 L is calculated
to be sufficient for machines without overfilling of product tank. A defined option
of other (larger) tank sizes to be included in offer.

7.1.2 Pressure: -1 to 3 bar, temperature up to 98°C

7.2 Circulation pump

7.2.1 Self priming, able to suck in water/air mixture. Frequency converter

7.2.2 Lifetime /running hours on circulation pump must be specified.

7.2.3 Supply specifications; for double index single lane machines flow requirement is
15m3/h.
Machine # of fillers Flow spec (l/h). Pressure spec.
cleaned sim. (MPa)

S-PS60EC 2 >10000 0,18-0,2

S-PM70UC 2

S-PS65UC 2 >15000 0,18-0,2

S-PS140UC 2 >15000 0,13-0,15

S-PS140UC 4 >30000 0,13-0,15

S-PS160UC 4 >20000 0,18-0,2

E-PS120A >14000 0,3

E-PL90HA 4

7.3 Heat exchanger

7.3.1 Heating capacity requirement
Unit must be able to heat cleaning liquid from cold to <80°C in less than 15
minutes, preferably shorter to reduce the total time. For rinsewater purpose, it
must be able to heat water from 5°C to 35°C without circulation.

If thermal disinfection is chosen, it must be able to heat up to 98°C in less than 25

minutes, preferably shorter to reduce the total time.

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7.3.2 Cooling capacity requirement
For some applications it may be favorable to cool down the water used for
thermal disinfection. Such option is not required.

7.4 Chemicals supply unit

7.4.1 The CIP/SIP unit must have dedicated cabinet for chemicals containers. There
must be room for 3 containers (min. size of each container 300x250x500mm). It
must be designed to avoid chemical cross-contamination in case of any
malfunctioning.

7.4.2 Each chemical have separate supply circuit with flow control.

7.5 Control of cleaning parameters

7.5.1 Caustic and acid concentration must be controlled by conductivity meter.

7.5.2 Concentration of peracetic acid (SIP) must be controlled by Optek AF-45HT in

case of chemical sterilization.

7.5.3 Automatic sampling of chemical for laboratory analysis must be standard. The
sampling is to take a representative sample from the cleaning or sterilization
liquid during CIP /SIP.

7.5.4 Temperature must be measured at supply (outlet from heat exchanger) and at
return from filling machine. Timer must be linked with temperature sensor on
return.

7.5.5 Flow meter must be installed at supply to machine (outlet from heat exchanger).
Additional flow meters may be installed for added functionality.

7.6 Circulation circuit

7.6.1 Supply pump is to be included with the standalone CIP unit. The pump must be
frequency controlled, self priming and able to suck in air-water mixture. It must
be able to supply the cleaning liquid to the machine at the specific flow and
pressure given by the machine specifications.

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7.7 Cleaning-In-Place (CIP) phase functionality
7.7.1 Sequences for a full CIP consist of the following steps which is described below.
The CIP standalone unit must be able to cope with such set-up in an efficient way.

Process step Time (min) Temperature (°C) Conc. (%) Comments

Pre-rinse with 10-15 Alternatively; Rinse water to drain,

water continue until water is
- cold clear of soil

- ambient

- start cold, warm up to

40°C

Alkaline Cleaning 30-50 70-75°C 1,3-2,0%*

Intermediate rinse 10-15 Cold, ambient or hot Continue rinse until pH is

neutral or conductivity is
(10 – 80°C) low

Acid cleaning 20-40 55-70°C 0,9-1,3*

Post rinse with 10-15 Cold, ambient or hot Continue rinse until pH is
water neutral or conductivity is
(10 – 80°C) low

1) Rinse. Rinsewater normally goes to drain and not back to the CIP tank The purpose of the rinse is
to remove as much product residues as possible. Rinsewater is normally cold, but it may be
beneficial to heat rinsewater to 30-40°C, so this must be an available option.

2) Caustic. Caustic sequence is a circulation of caustic chemical at typically 70-75°C for 30-50
minutes.

3) Intermediate rinse. This is applied to rinse out any caustic chemical to avoid chemical
interactions with acid. This rinse step may combine drain and circulation. Required length of
rinse is defined by the filling machine.

4) Acid. Acid cleaning is performed at different intervals, depending on application area and water
quality. It is foremost applied to remove milkstone and mineral deposits that come from product
(e.g. dairy) and supply water with high water hardness. Acid cleaning is typically performed at
55-70°C for 20-40 minutes.

5) Rinse. The final rinse is applied to avoid chemical standing in the system.

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7.7.2 Following the CIP, the unit must be drained completely.

7.7.3 Expected production hours between CIP is 24 hours. It must be possible for the
Customer to omit acid cleaning sequences for defined products which do not
require acid cleaning on a regular basis.

7.7.4 As an option, instrumentation can be fitted to the CIP system to enable dynamic
sequences based on actual conditions instead of predefined time intervals.

7.8 Sterilization-In-Place (SIP) phase functionality

7.8.1 SIP or alternatively disinfection phase is performed in one of the two ways
described below. Chemical sterilization to be standard, hot water disinfection
optional.

7.8.1.1 Chemical sterilization

1) Rinse (optional). Since both machine and CIP unit have rinse and drain sequence at end of CIP, a
rinse step before SIP/disinfection can be omitted.

2) Chemical sterilization. The peracetic acid chemical is dosed and concentration is controlled by
Optek sensor. The liquid is circulated through the filling machine for a predefined time typically
20-30 minutes. Temperature 20 -40 °C.

3) Drain. After chemical sterilization is ended, both filling machine and the CIP/SIP unit is drained

4) Post rinse. A post rinse with processed water or steam condensate is applied to remove residues
of sterilization chemical. Customer to supply steam or processed water to machine.

7.8.1.2 Thermal disinfection

1) Heating. Water is heated up to the pre-set temperature while circulating.

2) Thermal disinfection. Timer starts when temperature at return reaches the defined minimum
temperature. If temperature drops below the minimum for < X seconds, the timer is hold on
pause. If temperature drops below the minimum for > 60 seconds, timer is re-set.

3) Cooling. Heat exchanger may be used to cool down the water to < 40° to reduce waiting time
before production can start.

4) Drain. After thermal disinfection is ended, both filling machine and the CIP/SIP unit is drained.

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7.8.2 The system must be able to control chemical concentration, temperature and
flow. Data must be monitored and logged continuously.

7.8.3 Return pump including trough and level control to be incorporated in the filling
machine, ref chapter 7.6.

7.9 Machine Utility Connections

Utility connections for steam, compressed air, potable water and chilled water
shall be located at the same location.

7.10 Electrical
7.10.1 The load on the 3-phase power supply during normal operation must be balanced
equally across the 3 phases.

7.10.2 Electrical cabinet(s) must be designed as a separate module, but be fully

integrated in the machine.

7.10.3 Standalone electrical cabinets will not be accepted.

7.10.4 If required, air cooling systems must be included in the cabinets. Electric
ventilation fans must be protected by dust filters. Openings for air cooling must be
protected against water splashes during external cleaning of the filling machine.
Water cooled cabinets must be avoided.

7.10.5 Cable marking according to EN60204-1

7.10.6 All electric motors and drives 400 VAC, 50/60Hz.

7.11 Controls

7.11.1 A renowned, industrial system with European distributors is to be used for

controlling the standalone CIP unit.

7.11.2 Inside the cabinet where the PLC is located, there must be two CEE7 (Schuko)
power sockets available with 230V, 10A 50Hz.

7.11.3 The operator panel to be of standard touchpanel type with app. dimensions
500mm x 450mm x 45mm.

7.11.4 Supplier of the Operator panel must be well known and have European
distributors.

7.11.5 Operator panel must be easily cleanable.

7.11.6 One USB port must be located at the Operator panel.

7.11.7 A standard bus system to be used for internal communication within the filling
machine.

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7.11.8 A standard bus system to be used for external communication between the filling
machine and other equipment in the Customers production line, e.g. process
plant, downstream conveyors, wrap-around etc.

7.11.9 All technical documentation to be available from the Operator screen. This
includes all manuals, software documentation, pneumatic drawings, electrical
drawings, spare parts including vendor information and other relevant
documents.

7.12 Software
7.12.1 IEC-61131-3 compliant

7.12.2 All CCP’s must be monitored by the machine PLC. It must be possible to log the
CCP values continuously.

7.12.3 Alarms and data from CCP’s must be available for download to external memory
(flash disk) and/or remote connection (Ethernet, WLAN).

7.12.4 All set-points must be available from the Operator screen.

7.12.5 All control loops must be carefully tuned to minimize load on components.
Excessive temperature overshoot on startup of heaters must be avoided, equally
sufficient cooling time must be considered for shutdown.

7.13 Machine Safety System

7.13.1 Industrial system from renowned supplier, e.g. Jokab, ELAU, Mitsubishi or
Siemens.

7.13.2 Folding/sliding doors can have only one sensor covering both doors.

7.13.3 All alarms must be displayed on the Operator screen and be logged in an alarm
history file with memory backup for minimum 30 days.

7.13.4 The storage capacity and availability for the data history must comply with the
HACCP.

7.14 Transportation and installation

7.14.1 The crated CIP unit must be allowed for normal road transport.

7.14.2 Necessary lifting tools and frame supports for lifting/moving the machine on site
to be included in the machine delivery.

7.15 Servicing and maintenance

7.15.1 Expected lifetime of the CIP unit is > 4000 cleaning and sterilization sequences.

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7.15.2 Maintenance schedules including estimated service hours to be included in the
documentation.

7.15.3 Cost of purchased parts for each planned maintenance to be specified.

7.15.4 Cost of designed parts for each planned maintenance to be specified.

7.15.5 Setup tools to be supplied with machine

8 Technical Documentation
8.1.1 3D models in read- and editable formats.

8.1.2 2D blueprints read- and editable in DXF-format.

8.1.3 Electrical- and pneumatic schematics to be read- and editable in E-plan 8.

8.1.4 All technical documentation to be available in English language and in read- and
editable software formats;

- P&ID drawings where piping symbols and identification letters correspond

with ISO 10628 and ISO 14617. Instrumentation symbols according to EN
62424

- CCP documents corresponding with issued P&ID

- Calibration documents and methods for CCP

- HACCP

- Software documentation

- Operator panel documentation

- Mechanical drawings according to ISO 128

- Pneumatic schematics according to ISO 1219-1

- Electrical schematics, Electrical wiring diagrams according to ENA standard

- Flow charts for CIP/SIP, cooling water in P&ID format as specified

9 Technical Manuals

1. Operators and Maintenance Manuals should be developed according to Elopak standards,

in the English language.
2. All manuals required to operate and maintain the machine during FAT, IAT, and Beta
testing must be prepared and available prior to the beginning of FAT.

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 Sample Operators Manual Chapters:

• General Aspects
• Instruction Manual
• Safety
• Technical Data
• Structure and Function
• Operating Elements and Control Elements
• Operation
• Faults
• Maintenance
• Consumables and Supplies
• Glossary
• Bibliography

Sample Maintenance Manual Chapters:

• General Aspects
• Safety
• Transport, Packing and Storage
• Technical Data
• Installation and Commissioning
• Maintenance
• Faults
• Disassembly and Disposal
• Consumables and Supplies
• Index

3. An Installation Manual is necessary, in order to provide all required information for

installation, commissioning, de-commissioning, disassembly and transportation.

- This can be contained within the Operators Manual

4. Operator manual must be delivered in editable format for translation to local language.

- This can be QuickSilver data, but preferably in XML format

5. The Maintenance Manual must describe all procedures required for daily, weekly,
monthly, and preventive planned maintenance -- based on operation hours (see sample
above).
6. The Maintenance Manual must contain procedures for troubleshooting and the repair of
critical units.
7. The Spare Parts Manual must clearly identify each single part.
8. For all purchased components, one copy of the information supplied with each
component is to be collected in binders (i.e. Vendor Manual or Manual of Purchased
Parts).

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