Tem 3594390 0102 - 600V

TeM
Technical Manual
Tetra Pak® A3/Flex
648575-0600
Food Safety Chart
WARNING
Read and follow all safety precaution instructions throughout this
document and on safety signs attached to this equipment.
Failure to follow all safety precaution instructions could result in death or
serious injury.
Doc. No. TeM-3594390-0102

Copyright © 2019 Tetra Pak International S.A.
All rights reserved. No part of this document may be reproduced or copied in any form or by
any means without written permission from Tetra Pak Packaging Solutions.
, Tetra Pak, and all other trademarks displayed in this document are the property of the
Tetra Pak International SA. Tetra Pak Packaging Solutions together with Tetra Pak
International SA form part of ‘the Tetra Pak Group’. The content of this document is in
accordance with the design and construction of the machine or equipment at the time of
publishing. The Tetra Pak Group reserves the right to introduce design modifications without
prior notice.
The English language version of this document contains the original instructions. All other
language versions are translations of the original instructions.
This document was produced and printed by:
Tetra Pak Packaging Solutions
Via Delfini 1
41123 Modena
Italy
Doc. No. TeM-3594390-0102

Issue 2019-09
This document is valid for: Introduction
1 Food Safety Chart
Serial No. / Machine No.
Year of Manufacture Sign.
TeM
Technical Manual
Tetra Pak® A3/Flex

648575-0600
Machine or equipment configurations that

this document is valid for are described on
the next page.
Doc. No. TeM-3594390-0102

Issue 2019-09
Tetra Pak Packaging Solutions

Valid for:
Name Drawing Specification and Additional Information
Development Step
Tetra Pak® A3/Flex 648575-0600 All volumes

Direct Injection Moulded Concept 648478-0100 All volumes
(DIMC)
Headspace by Injection (HI) 2656910-0600 All volumes

Lower Filling Pipe Cleaner (LFPC) 3458563-0100 All volumes
PullTab (PT) 648556-0600 All volumes
Update Log for Doc. No. TeM-3594390-0102
This table shows all changes made to this document, including installed
rebuilding kits, added or removed pages. Page numbering on added pages
begins with UP.
Date Installed Kit Added Pages Removed Pages Signature

(Doc. No.)
Date Installed Kit Added Pages Removed Pages Signature
(Doc. No.)
Introduction
®
Doc. No. TeM-3594390-0102 7 (38)
Introduction
Description
This chapter contains basic information about this document and the related
Tetra Pak® equipment.
8 (38) Doc. No. TeM-3594390-0102

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Introduction Table of Contents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
General Information .............................................11

Content and Purpose .......................................... 12
How to Use the Food Safety Chart .......................... 13
Food Safety Chart Definitions and Legend ............... 14
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Legend Colour Coding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Hazard Analysis Critical Control Point (HACCP) ........ 15
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Doc. No. TeM-3594390-0102 9 (38)
Introduction
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10 (38) Doc. No. TeM-3594390-0102

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Introduction General Information
General Information
Food safety is related to the elimination and/or minimization of the risk of health
hazards in food products at the point of consumption. As food safety hazards may be
introduced at any stage of the food production chain, adequate control throughout
the food production chain is essential.
The establishment of documented Food Safety programs is paramount for any
organisation involved in manufacturing, catering and preparing food and food
ingredients. A suitable method to build Food Safety systems, acknowledged in many
legislation and recommended by FAO/WHO Codex Alimentarius Commission1, is the
HAZARD ANALYSIS and CRITICAL CONTROL POINT (HACCP)2, that focuses on
microbiological, chemical and physical hazards for food consumer's safety.
By definition, a food safety analysis or certification based on HACCP principles is

only meaningful when a complete specific production line for a specific food product
is considered. No HACCP analysis can then be created separately from the specific
production context for food processing and packaging equipment linked in a food
production chain.
According to the these principles, producers and distributors of food products shall
identify any step in their activity which is critical to ensuring food safety, and are
responsible to ensure that adequate monitoring and control measures are identified,
maintained and reviewed for every step identified.
The responsibility of creating and maintaining HACCP plans lies in all cases on who
manufactures, caters and prepares food. It is thus not possible for Tetra Pak or any
other equipment supplier, to certify any equipment to be utilised in food
manufacturing/handling operations according to a HACCP based food safety
program.
Even though Tetra Pak cannot issue HACCP plans for any supplied processing or
packaging equipment, internationally accepted general Hygienic Design and Food
Safety Principles are applied in internal development processes for Tetra Pak
processing and packaging equipment.
Tetra Pak also recognizes its responsibility to support customers/food manufacturers

in their food safety efforts through a clear and open communication of relevant food
safety information related to Tetra Pak supplied products and services.
In order to support our customers programs to establish preventive food safety
systems and comply with food safety regulations (where required), a specific Food
Safety Support document is provided with each Tetra Pak supplied piece of
equipment. This document consists of a common Introduction and an equipment-
specific Food Safety Chart (FSC).
1. FAO/WHO Codex Alimentarius, Doc. CAC/RCP 1/1969 "General Principles of Food Hygiene", Rev. 4 (2003). Website:
http://www.codexalimentarius.net.
2. See Hazard Analysis Critical Control Point (HACCP) on page 16, for more details.
®
Doc. No. TeM-3594390-0102 11 (38)
Content and Purpose Introduction
Content and Purpose

The Food Safety Chart is designed to support the establishment of HACCP Plans
(or other food safety programs based on HACCP principles) for production lines
involving Tetra Pak equipment. It is a support tool suitable for any preventive food
safety oriented analysis or program.
The FSC provides an overview of food safety relevant information related to

equipment functionality for the different process steps, as well as operational and
preventive maintenance requirements. In order to achieve the overview format only
part of all available food safety relevant information is covered in the document. The
selection of parameters is based on an assessed basic information need for a food
safety team working according to the HACCP principles. For each parameter
covered in the FSC, references are made to other machine specific documents
containing the complete and detailed information and data.
The content of the FSC document is based on Tetra Pak knowledge and experience
of potential food safety risks associated with the utilisation of equipment and how to
eliminate or reduce such risks through operational and maintenance procedures.
Please note that the processes reported in the FSC are described as originally
specified, designed and implemented by Tetra Pak. Any modification to processes,
parameters and critical limits (for instance to fill specific food products, or related to
production premises, line design, maintenance schemes, operator routines, quality
of utilities, etc., of a specific production line) is outside the scope of the FSC and is
not covered.
12 (38) Doc. No. TeM-3594390-0102

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Introduction How to Use the Food Safety Chart
How to Use the Food Safety Chart

For each unit of equipment, the Food Safety Chart describes the most important food
safety measures (under automatic monitoring) in order to eliminate potential food
safety related hazards in the different process steps. It also provides information on
control systems and measures to avoid food safety related hazards where
operational surveillance/testing are required. Critical limits and target values for
machine settings are given as well as requirements for the functionality of the
automatic systems in terms of tools, procedures and preventive maintenance.
The Food Safety Chart (FSC) does not necessarily include the complete detailed
information needed. It should therefore only be used as a complement to, and
always together with, other machine specific manuals supplied by Tetra Pak. For
each process step covered in the FSC there is a specific reference made to other
Tetra Pak manuals where the complete and detailed information is available.
The FSC document should primarily be used as a checklist during development of a
Food Safety plan/program for a production line which includes the specific
equipment unit. Distribution of the FSC to operators and maintenance staff for
purposes other than food safety analysis/planning is not recommended.
The FSC covers only Food Safety aspects and does not address other important
aspects of a food manufacturing line such as food quality, line efficiency, production
planning issues etc. Additional measures might need to be addressed and other
critical limits might apply in order to optimize other essential aspects of food
manufacturing and distribution.
To avoid misinterpretation it is important to observe the definitions listed below and
the explanatory legend of the FSC.
®
Doc. No. TeM-3594390-0102 13 (38)
Food Safety Chart Definitions and
Legend Introduction
Food Safety Chart Definitions and Legend

Definitions
Process Step
Name of the process and description of the method used for the process.
Food Safety Concern

Food safety hazard(s) addressed by the process step.
Control Parameter
Parameter(s) regulating the correct functioning of the process step.

Range (L = Low, H = High)
Value(s) of the control parameter that triggers a system response when exceeded.
Set Point
Value (or range of values) of the control parameter at which the process is designed
to operate.
Monitoring Procedure
Where automatic monitoring is implemented, the appliance in place to monitor the

control parameter is indicated. Otherwise, the manual monitoring procedure is
indicated.
Frequency
Type and timing of the automatic or manual monitoring procedure.

System Response in Case of Infringement of the Range Limit(s)
(Automatic monitoring only) Automatic corrective action taken by the equipment

when the automatic monitoring procedure detects a violation of the range limit(s).
Requirements
Actions or procedures required by the automatic system response or the manual
action to operate properly and effectively.
Reference Document (Ref. Doc.)
Reference to equipment-specific manuals (e.g. Operational Manual, Maintenance
Manual, Electrical Manual, etc.) for detailed information regarding control
parameters, ranges, set points, system responses or manual actions, requirements,
etc.
.
Legend Colour Coding

Grey background
No automatic monitoring/control - recommended to be considered in HACCP or

other food safety plan.
White background
Automatic monitoring/control - probability of failure low provided listed requirement

is met.
.
14 (38) Doc. No. TeM-3594390-0102

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Hazard Analysis Critical Control Point
Introduction (HACCP)

(HACCP)
The HACCP concept is a tool to identify potential health hazards and establish food
safety control systems throughout the food chain, from primary production to final
consumption. It is a preventive rather than controlling/testing methodology and
covers not only microbiological hazards but also chemical and physical hazards.
FAO/WHO Codex Alimentarius has issued food safety guidelines and

recommendations based on the HACCP principles and these guidelines have been
adopted globally in many national regulatory frameworks for food manufacturing
plants.
From FAO/WHO Codex Alimentarius, Doc. CAC/RCP 1/1969 "General Principles of
Food Hygiene", Rev. 4 (2003):
"(…) The HACCP system, which is science based and systematic, identifies specific
hazards and measures for their control to ensure the safety of food. HACCP is a tool
to assess hazards and establish control systems that focus on prevention rather than
relying mainly on end-product testing. Any HACCP system is capable of
accommodating change, such as advances in equipment design, processing
procedures or technological developments.
HACCP can be applied throughout the food chain from primary production to final
consumption and its implementation should be guided by scientific evidence of risks
to human health. As well as enhancing food safety, implementation of HACCP can
provide other significant benefits. In addition, the application of HACCP systems can
aid inspection by regulatory authorities and promote international trade by increasing
confidence in food safety.
The successful application of HACCP requires the full commitment and involvement
of management and the work force. It also requires a multi disciplinary approach; this
multi disciplinary approach should include, when appropriate, expertise in agronomy,
veterinary health, production, microbiology, medicine, public health, food technology,
environmental health, chemistry and engineering, according to the particular study.
The application of HACCP is compatible with the implementation of quality
management systems, such as the ISO 9000 series, and is the system of choice in
the management of food safety within such systems. (…)"
(Cont’d)
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Doc. No. TeM-3594390-0102 15 (38)
(HACCP) Introduction
(Cont’d)
The HACCP system consists of the following seven principles:

• PRINCIPLE 1
Conduct a hazard analysis.
• PRINCIPLE 2
Determine the Critical Control Points (CCPs).
• PRINCIPLE 3
Establish critical limit(s).
• PRINCIPLE 4
Establish a system to monitor control of the CCP.
• PRINCIPLE 5
Establish the corrective action to be taken when monitoring indicates that a
particular CCP is not under control.
• PRINCIPLE 6
Establish procedures for verification to confirm that the HACCP system is
working effectively.
• PRINCIPLE 7
Establish documentation concerning all procedures and records appropriate to
these principles and their application.
Main Internet websites for more information about HACCP principles and their
application in food production, catering and preparation:
• FAO/WHO Codex Alimentarius

(http://www.codexalimentarius.net)
• EU Food and Feed Safety, Food Hygiene
(http://ec.europa.eu/food/food/biosafety/hygienelegislation/index_en.htm)
• US FDA, Center for Food Safety and Applied Nutrition
(http://www.fda.gov/Food/default.htm)
.
16 (38) Doc. No. TeM-3594390-0102

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1 Food Safety Chart
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Doc. No. TeM-3594390-0102 17 (38)
1 Food Safety Chart
Description
The Food Safety Chart represents the primary source of information for a food
safety team working according to HACCP principles on the main processes
implemented as food safety measures in Tetra Pak equipment.
18 (38) Doc. No. TeM-3594390-0102

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1 Food Safety Chart Table of Contents
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.1 Cleaning of Product Contact Surfaces (ICU -

Integrated Cleaning Unit)...................................... 21
1.2 Creating Commercial Sterility Prior to Production ..... 26
1.3 Maintaining Commercial Sterility Throughout
Production ........................................................ 30
1.4 Production ........................................................ 33
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Doc. No. TeM-3594390-0102 19 (38)
1 Food Safety Chart
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20 (38) Doc. No. TeM-3594390-0102

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1.1 Cleaning of Product Contact
Surfaces (ICU - Integrated Cleaning
1 Food Safety Chart Unit)
1.1 Cleaning of Product Contact Surfaces

(ICU - Integrated Cleaning Unit)
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Doc. No. TeM-3594390-0102 21 (38)
Process Step Food Safety Concern Control Range Set Point Monitoring Frequency System Response in Case Requirement Reference
Parameter L = Low Procedure of Infringement of the Document
H = High Range Limit(s)
Unit)
Warm rinse, water
22 (38)
Temperature Calibration of the ICU Calibration
temperature L = 60.0 62.0 probe temperature probe Manual
(°C)
Warm rinse, water Continuous Calibration of the
Calibration
flow rate L = 9000 10000 Flow meter throughout the product/CIP flow
Manual
(l/h) warm rinse meter
Warm rinse, water
recirculation time (n/a) 10 PLC program Original PLC program EM
(minutes)
Alkaline solution,
concentration Calibration of the ICU
L = 71 Conductivity Calibration
measured as 73 conductivity meter
H = 98 meter Manual
conductivity
(mS/cm)
Alkaline solution, Temperature Calibration of the ICU Calibration
Microbiological temperature L = 80.0 82.0 probe temperature probe Manual
Cleaning In contamination caused (°C)
Place (CIP) by micro-organisms Alkaline solution,
Calibration of the
growing on food recirculation flow Calibration
"Daily Cycle" L = 9000 10000 Flow meter product/CIP flow

residues left on product rate CIP interrupted. Manual
meter
Method: contact surfaces (l/h) Operation of the machine not
1) warm rinse [Standard allowed until the affected

with water Allergen cross- machine] cleaning step has been
contamination caused Alkaline solution, 12 successfully repeated.
2) recirculation of by residues of recirculation time (n/a) PLC program Continuous Original PLC program EM
an alkaline allergenic foods left on (minutes) [Lower filling throughout the
solution product contact pipe cleaner] recirculation of
surfaces 18 the alkaline
[ Headspace by solution
Injection]
Doc. No. TeM-3594390-0102

Temperature at HI Calibration of the HI
Temperature Calibration
spray/CIP L = 65.0 ≥ 65.0 spray/CIP
probe Manual
temperature probe temperature probe
during alkali
recirculation
(°C)
[ Headspace by
Injection]
Time at T ≥ 65 °C L = 10 ≥ 10 PLC program Original PLC program EM

during alkali
recirculation
(minutes)
®
1 Food Safety Chart
Warm rinse, water Temperature Calibration of the ICU Calibration
temperature L = 60.0 62.0 probe temperature probe Manual
(°C)
Warm rinse, water Continuous Calibration of the
Calibration
flow rate L = 9000 10000 Flow meter throughout the product/CIP flow
Manual
(l/h) warm rinse meter
®
Warm rinse, water
1 Food Safety Chart
(minutes)
Alkaline solution,
concentration Calibration of the ICU
H = 98 meter Manual
conductivity
(mS/cm)
Cleaning In
Place (CIP) Alkaline solution, Temperature Calibration of the ICU Calibration
"Weekly Cycle" temperature L = 80.0 82.0 probe temperature probe
Microbiological Manual
(°C)
Method: contamination caused Alkaline solution,
by micro-organisms Calibration of the
1) warm rinse recirculation flow CIP interrupted. Calibration
growing on food L = 9000 10000 Flow meter product/CIP flow
with water rate Operation of the machine not Manual
residues left on product meter
(l/h) allowed until the affected
2) recirculation of contact surfaces cleaning step has been
[Standard
an alkaline machine] successfully repeated
solution Allergen cross-
Alkaline solution, 12
contamination caused Continuous (continues on next page)
recirculation time (n/a) PLC program Original PLC program EM
3) recirculation of by allergenic food throughout the
(minutes) [Lower filling
an acid solution residues left on product pipe cleaner] recirculation of
contact surfaces the alkaline
18
(continues on [Headspace by solution
next page) Injection]
Temperature at HI Calibration of the HI

Doc. No. TeM-3594390-0102

spray/CIP L = 65.0 ≥ 65.0 spray/CIP
probe Manual
temperature probe temperature probe
during alkali
recirculation
(°C)
[Headspace by
Injection]
Time at T ≥ 65 °C L = 10 ≥ 10 PLC program Original PLC program EM

during alkali
recirculation
(minutes)
23 (38)
Unit)
Unit)
(continued from Acid solution,
24 (38)
previous page) concentration Calibration of the ICU
H = 98 meter Manual
Cleaning In conductivity
Place (CIP) Microbiological (mS/cm) (continued from previous
"Weekly Cycle" contamination caused Acid solution, page)
Temperature Continuous Calibration of the ICU Calibration
by a loss of efficiency temperature L = 60.0 62.0 probe temperature probe
Method: throughout the Manual
of the pre-sterilization (°C) CIP interrupted.
1) warm rinse process due to recirculation of Operation of the machine not
with water Acid solution, the acid
accumulation of allowed until the affected Calibration of the
recirculation flow solution Calibration
mineral deposits inside L = 9000 10000 Flow meter cleaning step has been product/CIP flow
2) recirculation of rate Manual
product pipes successfully repeated meter
an alkaline (l/h)
solution Acid solution,
3) recirculation of (minutes)
an acid solution
Doc. No. TeM-3594390-0102

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1 Food Safety Chart
"Intermediate
CIP" (Cleaning
of the Filling
Machine while
the product
supply plant is
®
in operation) Chemical
contamination of the Temperature at the
Continuous
1 Food Safety Chart
Method: main product supply Aseptic Product CIP interrupted. Calibration of the
Valve steam Temperature throughout the Operation of the machine not Aseptic Product Valve
Interposition of caused by detergents Calibration
L = 105.0 110.0 probe recirculation of allowed. steam barrier
an activated leaking into the product barrier temperature Manual
probe alkaline and CIP to be repeated. temperature probe
steam barrier supply line during the
(°C) acid solutions
between aseptic CIP of the filling
filling machine machine
and product
supply plant
during Cleaning
in Place (either
"Daily" or
"Weekly")
Cleaning in
Place (CIP),
Final rinse cycle
with water
(all cycles)
Method: Chemical
Water conductivity CIP interrupted.
Recirculation of contamination caused At the end of
at the end of the Conductivity Operation of the machine not Calibration of the ICU Calibration
cold water by by residues of H = 1.5 ≤ 1.5 the rinsing
rinsing meter allowed. conductivity meter Manual
means of the detergents in product phase
(mS/cm) Rinsing to be repeated.
Integrated pipes after CIP
Cleaning Unit
(ICU) as final
step of the
Doc. No. TeM-3594390-0102

Cleaning in Place
(either "Daily" or
"Weekly")
Cleaning Out of Microbiological
Place (COP), contamination caused Visual
Cleanliness of Visually clean, Trained operator,
Manual by micro-organisms verification by
surfaces, absence (n/a) colourless, During the COP (n/a) manual cleaning tools
Cleaning growing on food machine OM
of colours and odourless adequate, in good
residues left on product operator
odours surfaces status and clean
Method: contact surfaces to be
Manual cleaning cleaned manually
25 (38)
Unit)
1.2 Creating Commercial Sterility Prior
to Production 1 Food Safety Chart
1.2 Creating Commercial Sterility Prior to

Production
26 (38) Doc. No. TeM-3594390-0102

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Range System Response in Case of
Process Step Food Safety Concern Control Monitoring Frequency Requirement Reference
L = Low Set Point Infringement of the Range
Parameter Procedure Document
H = High Limit(s)
Microbiological
Temperature of Continuous
contamination caused Calibration of
air sterilization Temperature from MACHINE
by micro-organisms superheated air Calibration
(incineration) L = 303.0 360.0 probe STERILIZA-
transported by the air temperature probe Manual
(°C) TION through 1. Stop and reset to
Sterilisation of supplied to the sterile PREPARATION (up to the end
PRODUCTION
air system of HEAT STERILIZATION)
®
[Headspace by
Method: Injection] Continuous 2. Stop, step to VENTING and
1 Food Safety Chart
Incineration Temperature of from HI reset to PREPARATION (from

(Dry heat) Microbiological SPRAYING to START Calibration of HI
air sterilization Temperature MACHINE Calibration
contamination caused L = 303.0 370.0 SEQUENCE) superheated air
(incineration) probe STERILIZA- Manual
by micro-organisms temperature probe
(°C) TION through
transported by the air PRODUCTION
supplied to the HI
circuit
Steam
temperature at Time limit for temperature to
Sterilization of Continuous Calibration of Aseptic
Microbiological the Aseptic restore above the Low Range
C-valve steam Temperature during HEAT Product Valve's steam
contamination caused Product Valve temp. = 60 sec. Calibration
barrier L = 127.0 130.0 probe STERILIZA- barrier temperature
by micro-organisms steam barrier In case of failure to restore: Manual
TION and probe
remaining in the temperature stop, step to VENTING and
Method: DRYING
Aseptic Product Valve probe reset to PREPARATION
Steam
steam barrier area (°C)
(Moist heat)
Exposure time PLC program At the end of Stop and reset to Original PLC program
L = 13 ≥ 13 EM
(minutes) DRYING PREPARATION
Total process
lethality FH L = 7.2∙105 ≥ 7.2∙105 PLC program Original PLC program
Microbiological EM
(equivalent time seconds seconds
contamination caused at 170 °C)
by micro-organisms
remaining on the Air temperature Continuous
internal surfaces of the threshold at during HEAT Calibration of
presterilization Temperature STERILIZA- Calibration
Sterilization of sterile air circuit L = 240.0 ≥ 240.0 presterilization
temperature probe TION Manual
Doc. No. TeM-3594390-0102

internal between superheater temperature probe
and hydrogen peroxide probe
surfaces
spray generator (°C)
(Heat
Sterilization) Stabilization time Step-up permission to
n/a 45 PLC program SPRAYING denied Original PLC program EM
(seconds)
Method: [Headspace by Air temperature
Hot air Injection] threshold at HI
(Dry heat) Calibration of HI
Microbiological superheated air Temperature Calibration
L = 330.0 ≥ 330.0 superheated air
contamination caused temperature probe Continuous Manual
temperature probe
by micro-organisms probe during HI HEAT
remaining on the (°C) STERILIZA-
internal surfaces of the TION
HI circuit between HI Exposure time
L=2 ≥2 PLC program Original PLC program EM
superheater and HI (seconds)
stainless steel filter
27 (38)
to Production
H = High Limit(s)
At the end of
28 (38)
H2O2 Calibration of the
HEAT Step-up permission to Calibration
concentration H2O2 concentration
STERILIZA- SPRAYING denied Manual
H2O2 meter meter
concentration L = 32 TION
35
(%) H = 50 Trained operator.
Manual
According to (n/a) Original nomogram
concentration OM
to Production
the OM from the OM (no

check
copy!)
During spray tank filling:
sterilization aborted and reset
to PREPARATION Verification of proper
Sterilization of Amount of H2O2 Spray tank level Continuous
internal functioning of the
Microbiological sprayed L = 100 ≥ 100 probes during During spray tank emptying: MM
surfaces spray tank level
contamination caused (ml) (min / max) SPRAYING sterilization interrupted,
(H2O2 probes
by micro-organisms perform shorter DRYING and
Sterilization)
remaining on the VENTING and reset to
internal surfaces of: PREPARATION
Method:
- sterile air pipes (after H2O2 injection Spray tank level Continuous Sterilization interrupted,
Circulation of hot
the H2O2 spray time L = 18 probes during SPRAY perform shorter DRYING and Original PLC program
hydrogen 18 - 38 EM
generator) (seconds) H = 38 (min / max) TANK VENTING and reset to
peroxide vapours
- aseptic chamber EMPTYING PREPARATION
for condensation
- product pipes During spray tank filling:
on internal
- [Headspace by sterilization aborted and reset
surfaces followed
Injection] HI circuit to PREPARATION
by drying with hot Continuous
air Sterile air flow during Calibration of the air Calibration

(continues on next L = 93 100 Air flow meter During spray tank emptying:
(m³/h) SPRAYING and flow meter Manual
page) sterilization interrupted,
(continues on DRYING
next page) perform shorter DRYING and
VENTING, and reset to
PREPARATION
[Standard
machine]
n/a 15
Doc. No. TeM-3594390-0102

Drying time
(minutes) Sterilization interrupted, step to
Continuous
[Configuration PLC program VENTING and reset to Original PLC program EM
during DRYING
with Headspace PREPARATION
by Injection] n/a 20
Drying time
(minutes)
®
1 Food Safety Chart
H = High Limit(s)
During spray tank filling:
sterilization aborted and reset
[Headspace by to PREPARATION
(continued from Injection] HI spray tank Continuous Verification of proper
previous page) Amount of H2O2 L = 18 ≥ 18 level probes during During spray tank emptying: functioning of HI spray MM
(continued from sprayed (min / max) SPRAYING sterilization interrupted, tank level probes
®
previous page) (ml) perform shorter DRYING and
Sterilization of
internal VENTING and reset to
Microbiological
1 Food Safety Chart
surfaces PREPARATION
contamination caused
(H2O2 [Headspace by
by micro-organisms Continuous Sterilization interrupted,
Sterilization) Injection]
remaining on the PLC program during SPRAY perform shorter DRYING and Original PLC program
H2O2 injection H = 25 ≤ 25 EM
internal surfaces of: TANK VENTING and reset to
Method: time
- sterile air pipes (after EMPTYING PREPARATION
Circulation of hot (seconds)
the H2O2 spray
hydrogen generator) [Headspace by
peroxide vapours - aseptic chamber Injection]
for condensation - product pipes Temperature
on internal - [Headspace by Monitor HI Spray Sterilization interrupted,
surfaces followed Calibration of HI
Injection] HI circuit (∆°C vs. Temperature At the end of perform shorter DRYING and Calibration
by drying with hot L = 25.0 ≥ 25.0 spray/CIP
reference probe SPRAYING VENTING and reset to Manual
air temperature probe
temperature PREPARATION
measured before
SPRAYING)
(°C)
Doc. No. TeM-3594390-0102

29 (38)
to Production
1.3 Maintaining Commercial Sterility
Throughout Production 1 Food Safety Chart

Throughout Production
30 (38) Doc. No. TeM-3594390-0102

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Supply of sterile Microbiological PRODUCTION interrupted
air to Aseptic contamination caused Temperature of air (forcing to perform inching if Calibration of
Chamber by airborne micro- sterilization Temperature Continuous
required), step to END superheated air Calibration
organisms transported (incineration) L = 303.0 360.0 probe during
PRODUCTION and temperature probe Manual
Method: by the air supplied to (ºC) PRODUCTION
VENTING, and reset to
Incineration the sterile system
®
PREPARATION
(Dry heat)
(L) PRODUCTION
1 Food Safety Chart
Overpressure in interrupted (forcing to perform

Aseptic Microbiological inching if required), step to
Chamber contamination caused Production: END PRODUCTION and
Pressure in the 300 - 800 Continuous VENTING, and reset to Calibration of the
by penetration of L = 100 Calibration
Method: Aseptic Chamber Pressure sensor during PREPARATION Aseptic Chamber
airborne micro- H = 1500 Manual
Aseptic chamber (Pa) Stops: PRODUCTION pressure sensor
organisms into the
maintained in Aseptic Chamber ≥ 150 (H) Stop with permission to
overpressure of resume PRODUCTION
sterile air denied until the correct
pressure is restored
Heated Aseptic
Chamber Microbiological
Temperature in the Continuous Calibration of the
Method: by penetration of L = 72.0 Temperature Calibration
Aseptic Chamber 78.0 during Stop in PRODUCTION Aseptic Chamber
Aseptic chamber airborne micro- H = 110.0 probe Manual
(ºC) PRODUCTION temperature probe
supplied with organisms into the
sterile air at high Aseptic Chamber
temperature
Steam
Temperature in Informative alarm displayed
Microbiological Temperature at the on TPOP while
Aseptic Product
contamination caused Aseptic Product PRODUCTION continues Calibration of the
Valve
by penetration of Valve steam Temperature Continuous regularly. Aseptic Product Valve Calibration
waterborne micro- bypass L = 107.0 110.0 probe during After any stop, restart of steam bypass
Method: Manual
organisms into the temperature probe PRODUCTION PRODUCTION is not allowed temperature probe
Temperature
Aseptic Product Valve
Doc. No. TeM-3594390-0102

Controlled Steam (ºC) until the correct steam
steam barrier area temperature is restored
Barrier
(TCSB)
(Cont’d)
31 (38)
(Cont’d)
32 (38)
[Headspace by
Injection]
Microbiological Temperature of HI PRODUCTION interrupted
Supply of sterile contamination caused (forcing to perform inching if Calibration of HI
air/filling gas Continuous
air/filling gas to by micro-organisms Temperature required), step to END superheated air/filling Calibration
sterilization L = 303.0 360.0 during
HI circuit transported by the air probe PRODUCTION and gas temperature Manual
(incineration) PRODUCTION
supplied to the HI VENTING, and reset to probe
(ºC)
Method: circuit PREPARATION
Incineration
(Dry heat)
[Headspace by
Injection]
Overpressure in Microbiological PRODUCTION interrupted

HI circuit contamination caused Pressure in the HI (forcing to perform inching if
Continuous Calibration of HI
by penetration of circuit L = 0.1 required), step to END Calibration
0.1 - 6.0 Pressure sensor during circuit pressure
Method: airborne micro- (bar) H = 6.0 PRODUCTION and Manual
PRODUCTION sensor
HI circuit organisms into the HI VENTING, and reset to
maintained in circuit PREPARATION
overpressure of
sterile air/filling
gas
Doc. No. TeM-3594390-0102

®
1 Food Safety Chart
1 Food Safety Chart 1.4 Production
1.4 Production
®
Doc. No. TeM-3594390-0102 33 (38)
Process Step Food Safety Concern Control Range Set point Monitoring Frequency System Response in Case Requirement Reference
Calibration of the
34 (38)
H2O2
Stop in PRODUCTION H2O2 Calibration
concentration Continuous
concentration Manual
meter
H2O2 concentration L = 31 meter
(%) 35
H = 50 Original
Manual According to
nomogram from
concentration OM and n/a OM
the OM (no
check Customer GMP
1.4 Production
Sterilization of copy!)
packaging
Calibration of
material Bath temperature Temperature
Microbiological L = 80.3 H2O2 bath Calibration
(ºC) 83.0 probe Continuous
contamination caused H = 95.0 temperature Manual
Method:
by micro-organisms probe
Immersion in a
carried by the Verification of
bath of liquid
packaging material H2O2 bath level proper
H2O2 at high Continuous MM
concentration probe functioning the
and temperature Stop in PRODUCTION level probe
L = 4.7 Verification of
Contact time
H = 8.3 (Note A) proper
(seconds)
(Note A) functioning of the
Machine
Continuous Motion Control MM, EM
capacity
System.
Original PLC
program
Drying of H2O2
residues from
packaging Chemical
material Calibration of the
contamination caused Air knife air
Temperature air knife Calibration
by residues of H2O2 temperature L = 167.3 175.0 Continuous Stop in PRODUCTION
Method: probe temperature Manual
remaining on (ºC)
Drying with sterile probe
packaging material
air at high
temperature
Doc. No. TeM-3594390-0102

(air knife)
Application of Power Sealing Verification of
Microbiological (Note B) (Note B) Stop in PRODUCTION EM, MM
Longitudinal (W) Monitoring Continuous proper
Sealing (LS) System functioning
by micro-organisms
strip
migrating from the edge Proper LS Manual checks
of the packaging Quality of LS strip Bad LS strip According to Trained operator,
strip of LS strip n/a OM
Method: application application OM dedicated tools
material application application
Induction Heating
Longitudinal Microbiological Power Sealing Verification of
seal (LS) of the contamination caused (Note B) (Note B) Monitoring Continuous Stop in PRODUCTION proper EM, MM
(W)
package by environmental System functioning
micro-organisms
Method: penetrating through Quality of LS Bad LS quality Proper quality Manual checks According to Trained operator,
n/a OM
Induction Heating defective seals of LS of LS OM dedicated tools
Transversal Microbiological Power Sealing Verification of
seals (TS) of the contamination caused (Note B) (Note B) Monitoring Continuous Stop in PRODUCTION proper EM, MM
(W)
package by environmental System functioning
micro-organisms
Proper quality Manual According to Trained operator,
Method: penetrating through Quality of TS Bad TS quality n/a OM
of TS stretching of TS OM dedicated tools
Induction Heating defective seals
®
1 Food Safety Chart
Microbiological Presence of cap Cap present Cap Detector for
n/a Continuous DIMC MM
contamination caused Missing Caps
by environmental Verification of
micro-organisms Stop in PRODUCTION proper
Absence of Cap Detector for
penetrating through Cap membrane functioning
n/a holes in the Underfilled Continuous DIMC MM
defective or improperly integrity
Caps
®
attached DIMC opening membrane
devices
1 Food Safety Chart
[DIMC] Package with plastic lump(s)

Application of a ≥ 2×3 mm: Affected package Verification of
DIMC opening Physical contamination
Size of plastic wasted, alarm on operator proper
device to the of the internal surface
lumps leaked on panel functioning of the
packaging of the packaging PE Particle
packaging material H < 2×3 < 2×3 Continuous sensor DIMC MM
material material caused by Detector
internal surface 2 packages with plastic (procedure in
lumps leaked from the
(mm) lump(s) ≥ 2×3 mm in 4 preparation);
Method: DIMC injection system
consecutive packages: Stop trained operator
Injection in PRODUCTION
moulding on both Manual
sides of the Sealing of cap to Cap properly verification of According to
packaging Microbiological n/a n/a Trained operator OM
packaging material sealed proper cap OM
material contamination caused sealing
by environmental
micro-organisms Cap membrane Manual
measurement of According to Trained operator,
penetrating through thickness (Note C) (Note C) n/a OM
membrane OM microscope
defective or improperly (mm)
attached DIMC opening thickness
devices Proper Manual Trained operator,
Cap positioning According to
n/a positioning positioning n/a dedicated OM
OM
verification templates
Doc. No. TeM-3594390-0102

35 (38)
1.4 Production
Sealing of the
36 (38)
Sealing Verification of
patch by induction (Note C) (Note C) Monitoring Stop in PRODUCTION proper
Continuous PT MM
heating, power System functioning
(W)
Patch applied
and Verification of
Patch application IS Patch
n/a completely Continuous Stop in PRODUCTION proper PT MM
and hole coverage
1.4 Production
Detector functioning
covering the
hole
Sealing of the tab Calibration of the
by heat, tab feeder Temperature Calibration
(Note C) (Note C) Continuous Stop in PRODUCTION temperature
temperature probe Manual
probe
(°C)
[PullTab] Sealing of the tab
Application of a by heat, tab Calibration of the
PullTab opening counter-jaw (Note C) (Note C) Continuous Stop in PRODUCTION temperature
probe Manual
device to the temperature probe
packaging (°C)
material Microbiological Tab applied
contamination caused and Verification of
Method: by environmental Tab application and IS Patch
n/a completely Continuous Stop in PRODUCTION proper PT MM
Sealing of a micro-organisms hole coverage Detector
covering the functioning
patch (inner side) penetrating through hole
and a pull tab improper or defective
Trained operator,
(outer side) over patch / tab application PullTab position (Note C) (Note C) Manual position According to
n/a dedicated OM
a hole punched in verification OM
templates
the packaging
material Manual hole According to
(continued on Hole position (Note C) (Note C) position n/a Trained operator OM
OM
next page) verification
Extension of tab Manual
According to Trained operator
around the hole L = 0.5 ≥ 0.5 coverage n/a OM
OM
(mm) verification
Doc. No. TeM-3594390-0102

Air gap size Manual
L = 0.5 According to Trained operator
(mm) 0.5 - 3.0 measurement of n/a OM
H = 3.0 OM
gap size
Extension of patch Manual
According to Trained operator
around the hole L = 2.0 ≥ 2.0 coverage n/a OM
OM
(mm) verification
No red ink Trained operator,
Patch sealed to penetration Manual sealing According to
n/a n/a red ink test OM
packaging material through patch verification OM equipment
edges
Notes:
A) 4.7 seconds represent the minimum contact time allowed for the Tetra Pak A3/Flex 0600, and is reached by the volume TBA 1000 UE at the maximum capacity of 7,537.5 p/h. All other Tetra Brik Aseptic,
Tetra Prisma Aseptic, Tetra Gemina Aseptic and Tetra Stelo Aseptic package sizes are used at a lower web speed and are then subjected to longer exposure times in the hydrogen peroxide bath.
B) Set points and related range limits vary with volume, packaging material type and LS strip type.
C) Set points and related range limits vary with volume, packaging material type and hole type.
®
1 Food Safety Chart
logo page 1
TP Logo page
®
Label for 40 mm binder Note! This page is generated automatically.
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Tetra Pak® A3/Flex Tetra Pak® A3/Flex 1(2)
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Tetra Pak® A3/Flex 1(2) Tetra Pak® A3/Flex 2(3)

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Tetra Pak® A3/Flex 2(2) Tetra Pak® A3/Flex 3(3)

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Tem 3594390 0102 - 600V

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Doc. No. TeM-3594390-0102

Doc. No. TeM-3594390-0102

Tetra Pak® A3/Flex

Machine or equipment configurations that

Doc. No. TeM-3594390-0102

Tetra Pak Packaging Solutions

Tetra Pak® A3/Flex 648575-0600 All volumes

Headspace by Injection (HI) 2656910-0600 All volumes

Date Installed Kit Added Pages Removed Pages Signature

8 (38) Doc. No. TeM-3594390-0102

General Information .............................................11

Hazard Analysis Critical Control Point (HACCP) ........ 15

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10 (38) Doc. No. TeM-3594390-0102

By definition, a food safety analysis or certification based on HACCP principles is

Tetra Pak also recognizes its responsibility to support customers/food manufacturers

Content and Purpose

The FSC provides an overview of food safety relevant information related to

12 (38) Doc. No. TeM-3594390-0102

How to Use the Food Safety Chart

Food Safety Chart Definitions and Legend

Food Safety Concern

Parameter(s) regulating the correct functioning of the process step.

Where automatic monitoring is implemented, the appliance in place to monitor the

Type and timing of the automatic or manual monitoring procedure.

(Automatic monitoring only) Automatic corrective action taken by the equipment

Legend Colour Coding

No automatic monitoring/control - recommended to be considered in HACCP or

Automatic monitoring/control - probability of failure low provided listed requirement

14 (38) Doc. No. TeM-3594390-0102

Hazard Analysis Critical Control Point

FAO/WHO Codex Alimentarius has issued food safety guidelines and

The HACCP system consists of the following seven principles:

• FAO/WHO Codex Alimentarius

16 (38) Doc. No. TeM-3594390-0102

18 (38) Doc. No. TeM-3594390-0102

1.1 Cleaning of Product Contact Surfaces (ICU -

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20 (38) Doc. No. TeM-3594390-0102

1.1 Cleaning of Product Contact Surfaces

"Daily Cycle" L = 9000 10000 Flow meter product/CIP flow

1) warm rinse [Standard allowed until the affected

Doc. No. TeM-3594390-0102

Time at T ≥ 65 °C L = 10 ≥ 10 PLC program Original PLC program EM

Temperature at HI Calibration of the HI

Doc. No. TeM-3594390-0102

Time at T ≥ 65 °C L = 10 ≥ 10 PLC program Original PLC program EM

Doc. No. TeM-3594390-0102

Doc. No. TeM-3594390-0102

1.2 Creating Commercial Sterility Prior to

26 (38) Doc. No. TeM-3594390-0102

Incineration Temperature of from HI reset to PREPARATION (from

Doc. No. TeM-3594390-0102

the OM from the OM (no

air Sterile air flow during Calibration of the air Calibration

Doc. No. TeM-3594390-0102

Doc. No. TeM-3594390-0102

1.3 Maintaining Commercial Sterility

30 (38) Doc. No. TeM-3594390-0102

Overpressure in interrupted (forcing to perform

Doc. No. TeM-3594390-0102

Overpressure in Microbiological PRODUCTION interrupted