Quality Assurance

• to prevent any deviation from stated

quality specifications
• quality specifications should be
integrated

1
TM-00034:1

Quality Assurance
While quality control should be done by a limited number of people,
everyone working in the plant should be part of a quality assurance program.
Production of long-life low acid products especially, involves high risks and
potential failure. This demands a highly efficient performance at each
“operation unit” stage. Operational procedures must be documented and
skilfully supervised. Control of the production process is much more effective
and much more important than the control of the final product. Suitable
means of assuring the production of safe and wholesome products of
adequate quality should be introduced in every task of operation.
This is the intent of quality assurance: To prevent any deviation from the
stated quality specifications and to integrate specifications.

Source:BvB Doc

TM-00034:1 1
 Departments involved in QA

• Quality control
• Production
• Maintenance
• Marketing
• Senior management

2
TM-00034:2

Departments involved in QA
The input and participation of the quality control staff can be seen in many
aspects of the QA system. Their participation in elaborating quality
specifications, and a documentation system, and their immediate reporting if
quality deviations are encountered, verification of proper functioning of the
quality system, participation in training and education programs for the staff,
participation in group developments and implementing quality assurance
procedures. The production department plays an important role in any
quality assurance program . The participation of the production department
can be seen in elaboration of quality specifications, proper execution of all
scheduled processes, development and implementation of a functioning
supervision system, implementation of training and education program of the
staff, preparation for proper maintenance of all equipment, preparation and
implementation of proper production planning and planning for production
of a certain defined amount of products within a specified period of time.
Often maintenance is part of the production department. Input can be in the
form of participation in establishing quality specifications, proper training
and education of all maintenance staff, development of realistic time
schedules needed for maintenance work, and execution of maintenance work
in a professional and adequate way. The participation of the Marketing
department should not be forgotten. It could be in the form of participation
in elaborating quality specifications,

TM-00034:2 2
 Departments involved in QA

• Quality control
• Production
• Maintenance
• Marketing
• Senior management

3
TM-00034:3

providing the production department with a reasonably correct market

prognosis and/or training and education of the retail chain. Senior
management involvement is vital and critical in order to establish a company
quality policy and to provide the economical frame work for quality
performance to confirm quality specifications, confirm and strongly support
the organisational structure and to employ qualified and suitable middle
management.

Source: BvB Doc

TM-00034:3 3
 ISO 9000, GMP, QACP and
HACCP
ISO 9000

GMP

QACP

HACCP

4
TM-00034:4

ISO 9000, Good Manufacturing Practices, Quality Assurance Control

Points and Hazard Analysis Critical Control Points.
The ISO 9000 describes a quality system in general for all manufacturing
enterprises. It demands proper implementation. An ISO 9000 certificate can
be obtained if execution and documentation fulfil specified requirements.
GMP guidelines are more specific and may deal with branches of the food
industry, special food groups, etc. The HACCP methodology is very specific.
It deals with one product and one production line at a time. QACP can apply
the same methods as HACCP, i.e. identify point in the production that are of
importance for the quality of the product, not only the hazards causing
public health risks. The introduction (documentation and implementation) of
an acceptable quality assurance system and a HACCP methodology can lead
to the reduction of official routine inspections thus considerably reducing
inspection costs.

Source: BvB Doc

TM-00034:4 4
 ISO 9000
• Quality Manual
• Quality Procedures
• Work Instructions

5
TM-00034:5

ISO 9000
ISO 9000 outlines the requirements for a quality system in general and offers
the possibility of certification. More and more companies acquire ISO 9000
certification and demand the same from their suppliers. Basically, the ISO
9000 system requires a documented quality system consisting of complete
verification of processes, products, and procedures, quality specifications,
and a suitable organisation. The Quality manual has a short outline which
provides a description of the quality policy of the company in question. All
points of the appropriate ISO 9000 standard should be addressed in the
manual. The Quality procedures describe how the information in the Quality
manual should be utilised and implemented. The procedures will answer the
questions who, where and when? The work instructions describe in detail how
the procedures are to be accomplished.

Source: BvB Doc

TM-00034:5 5
 Good Manufacturing Practices

• should be in writing
• legislation on GMPs
• co-operation between legislator
and industry
• process control
• emergency program

6
TM-00034:6

Good Manufacturing Practices

GMPs are guidelines for the production of safe food products. GMPs state the
steps that a processor of low and high acid food should take in order to
ensure that his products are hazard-free and to minimise his commercial
losses due to non-sterile, or any other, quality deviations in the product.
While ISO 9000 is applicable to the total manufacturing industry, GMPs are
more specific. They may cover the food industry in general, a branch, or a
product group. Larger food producing companies often have their own
GMPs. GMPs are often based on experience. Though often transferred by
word of moouth and action, they really should be put down in writing.
In several countries (USA, Canada, Taiwan etc.) the legislators either have
regulated GMPs for certain food groups or issued recommendations to this
effect. At the present time, rules, guidelines and regulations covering GMPs
for long-life food products are being formulated in an increasing number of
countries, either on a voluntary or legislative basis. Though legislators often
have an understandable desire to regulate aseptic technology, they are usually
lacking the necessary knowledge.Therefore, the industry concerned should
observe this development closely and,whenever possible in co-operation with
the legislator, take an active part in it. GMPs require that scheduled processes
are established, that control points and parameters are identified and that
process control instruments are calibrated regularly.
Part of the GMPs is the establishment of an “emergency program” which
should be developed in due time. A recall plan must include how to locate and
retrieve affected stock and how to notify the trade and consumers of the
recall.
Source: BvB Doc

TM-00034:6 6
 Quality Assurance

7
TM-00034:7

Quality Assurance
The HACCP should be restricted to potential public health hazards. Product
spoilage and other quality properties should be excluded. Furthermore,
quality assurance is of strictly commercial interest to the food business
operators.
The definition of the concept included originally microbiological safety and
spoilage, but due to the Codex definitions the acronym HACCP is now
reserved for aspects of the food chain dealing with safety and wholesomeness
only, consisting of microbiology hazards as well as physical and chemical
hazards. This result does not exclude that the systematic approach may
equally be applied to non-safety aspects of food quality where it is applicable.
The HACCP methodology can be used as a QA tool for other quality aspects
than those concerning food safety, then called Quality Assurance Control
Points. Also in development this is of a certain significance. HACCP
methodology should be used as a tool at an early development level. Thus,
potential hazards and other quality problems can be eliminated at the design
phase and costly correction procedures can be avoided afterwards. There is
money to gain by including and implementing the HACCP methodology or
QACP in the development phase.
Introduction (documentation and implementation) of an acceptable quality
assurance system and a HACCP concept could lead to the reduction of official
routine inspections and thus considerably reduce inspection costs.

TM-00034:7 7
 HACCP/QACP

HACCP QACP
deals with public deals with product
health issues spoiling issues

8
TM-00034:8

HACCP/QACP
The HACCP should be restricted to dealing with potential public health risks,
i.e product spoilage and other quality properties should be excluded. This
does not mean that the HACCP methodology cannot be applied on quality
assurance in general. The FAO/WHO Codex Alimentarius HACCP
Guidelines state “While the application of HACCP to food safety was
considered here, the system can equally be applied to other aspects of food
quality”. IDF (International Dairy Federation) say that “This result does not
exclude that the systematic approach may equally be applied to non-safety
aspects of food quality where it is applicable.”
The HACCP methodology can be used as a QA tool for other quality aspects
than those concerning food safety. Also in development this is of a certain
significance. HACCP methodology should be used as a tool at an early
development level. Thus, potential hazards and other quality problems can be
eliminated at the design phase and costly correction procedures can be
avoided afterwards. There is money to gain by including and implementing
the HACCP methodology or QACP in the development phase.

TM-00034:8 8
 Hazard Analysis Critical Control
Point
• look at your process/product from start to finish
• decide where hazards occur
• introduce checks and control points and monitor
them
• write down all information and keep records
• ensure that the system continues to work efficiently

9
TM-00034:9

Hazard Analysis Critical Control Point

Today, the Hazard Analysis Critical Control Point (HACCP) concept is the
most powerful tool available to minimise public health hazards. At the
present, the European Union has issued a directive demanding the mandatory
introduction of HACCP in the food industry. The US FDA has already
published a regulation requiring the fish industry to implement HACCP. It is
to be expected that an increasing number of countries will render HACCP
compulsory.
Briefly, HACCP is implemented by taking a number of steps:
•look at your process/product from start to finish
•decide where hazards occur
•introduce checks and control points and monitor them
•write down all information and keep records
•ensure that the system continues to work efficiently

Source:Mortimore, S. and Wallace, C. HACCP-A practical approach

TM-00034:9 9
 HACCP
RULES and RECOMMENDATIONS

Global : Codex, ILSI, ICMSF, assign HACCP

for product safety.
USA: FDA, Inspection programme
EU: Hygien directives + Industry directives
(Fish, meat, milk based products)
EEC 93/43
Countries: Own

10
TM-00034:10

TM-00034:10 10
 HAZARDS
Biological : Pathogenic micro-organisms
ex. Salmonella sp., Staphylococcus
aureus

Chemical : Residues of agents

ex. cleaning/ disinfection/ sterilizing,
pesticides, allergens, veterinary
residues, packaging migration etc.

Physical : Foreign materials

ex. screws, nuts, glass etc.

11
TM-00034:11

One of the key issues is how ‘hazard’ is defined. Almost all publications
restrict the application of this word to ‘food safety risks’ and ‘public health
risks’. Many of the published statements refer to the FAO/WHO Codex
Alimentarius HACCP Guidelines: “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”.

TM-00034:11 11
 HACCP GOALS

• SAFE PROCESS
• COMPETITION
• INCREASED CONFIDENCE
• COST EFFICIENCY
• DECREASED QUALITY DEVIATION

12
TM-00034:12

TM-00034:12 12
 Key objectives for HACCP
• To continuously produce a safe product
• To provide evidence of safe production and
handling of food
• To maintain confidence in your product
• To satisfy customer requests for HACCP
• To comply with regulatory guidelines

13
TM-00034:13

Key objectives for HACCP

•To continuously produce a safe product
•To provide evidence of safe production and handling of food. This is
particularly useful during regulatory inspection or prosecution.
•To maintain confidence in your product and thereby ensure that customers
have confidence in your ability
•To satisfy customer requests for HACCP to attain international standards
•To comply with regulatory guidelines

Additional objectives may include

•To involve personnel from all departments and at all levels in the
implementation of HACCP. The management of food safety thus becomes
everyone’s responsibility
•To direct the company towards a Quality Management System which may be
certified to ISO 9001 - HACCP is considered to be one of the key steps
towards certification.
••To use resources cost effectively - where limited technical resources are
targeted and focused upon, and where capital expenditure should be carefully
monitored.

Source:Mortimore, S. and Wallace, C. HACCP-A practical approach

TM-00034:13 13
 HACCP END PRODUCT
HAZARD ANALYSIS

Raw Aseptic Storage &

material Processing Transfer Packaging Dist.

14
TM-00034:14

TM-00034:14 14
 HACCP END PRODUCT
Raw Processing Aseptic Packaging Storage&
Material Transfer Dist.

- PATHOGENS
HACCP - CHEMICAL POLLUTION
- FOREIGN SUBTANCES

15
TM-00034:15

TM-00034:15 15
 HACCP END PRODUCT
Raw Processing Aseptic Packaging Storage&
Material Transfer Distr.

Preparation PATHOGENS

Sterilisation
CHEMICAL POLLUTION
Production

Cleaning FOREIGN SUBTANCES

No Production
16
TM-00034:16

TM-00034:16 16
 HACCP END PRODUCT
Raw Processing Aseptic Packaging Storage&
Material Transfer Distr.

Risk Identification
PATHOGENS
Critical Control Points

Critical Limits
Supervision CHEMICAL POLLUTION
Corrective Action
Documentation
FOREIGN SUBTANSCES
Verification

17
TM-00034:17

Principles of HACCP
The HACCP system will be based on seven principles which outline how to
establish, implement and maintain a HACCP plan. The principles have been
described in the Codex Alimentarius.
Principle 1: Identify potential hazards associated with food production at all
stages and describe the preventive measures.
Principle 2: Identify the Critical Control Points in the process. A CCP is a
point step or procedure at which control can be applied and a food safety
hazard eliminated or reduced to an acceptable level.
Principle 3: Establish Critical Limits for preventative measures associated
with each identified hazard. Each CCP needs to have a minimum or
maximum critical limit. Any deviation from this will trigger an action plan
designed to locate and rectify the problem.
Principle 4: Establish CCP monitoring requirements. Each CCP needs to be
monitored and monitoring requirements should be established. This ensures
that each CCP is checked by scheduled testing or observations. The frequency
of monitoring must be established as well as the monitoring responsibilities.

TM-00034:17 17
 HACCP END PRODUCT
Raw Processing Aseptic Packaging Storage&
Material Transfer Distr.

Risk Identification
PATHOGENS
Critical Control Points

Critical Limits
Supervision CHEMICAL POLLUTION
Corrective Action
Documentation
FOREIGN SUBTANSCES
Verification

18
TM-00034:18

Principle 5: Establish corrective actions. The HACCP plan must include

corrective actions to be taken when monitoring indicates that there is a
deviation from a critical limit at a CCP.
Principle 6: Establish effective record keeping which documents the HACCP
system. Records must be kept to demonstrate that the HACCP system is
operating under control.
Principle 7:Establish procedures which verify that the HACCP system is
working correctly. The verification must be done periodically in order to
check if the system is applied as intended, whether the system works correctly
and effectively and/or whether the system needs reviewing and improvement.

Source:Mortimore, S. and Wallace, C. HACCP-A practical approach

TM-00034:18 18
 HACCP-CHECKLIST
Important steps for HACCP implementation:

1. Create a HACCP-team
2. Define the scope of the study
3. Define the hazard/risk
4. Describe the product
5. Describe the use of the product
6. Make a flowchart
7. Verify the flowchart
8. Identify all hazards/risks
9. Make a list of preventive actions for the hazards /
risks

19
TM-00034:19

TM-00034:19 19
 HACCP-CHECKLIST cont.
Important steps for HACCP implementation:

10. Identify all control points

11. Define all critical limits
12. Create a supervison system for each CCP
13. Establish corrective actions for deviation from a CCP
14. Train personnel in the subjects of hygiene and HACCP
15. Describe verification routines
16. Create a filing and documentation system
17. Describe routines for revision

20
TM-00034:20

TM-00034:20 20
 Introduction of a QACP Program
(1)
• Commitment of senior management
• Team work
• Identification of product to be studied
• Description of the production line
• Identification of the hazards for food
spoilage
– physical,chemical and biological
(to be continued)
be) 21
TM-00034:21

Introduction of QACP Program (1)

A precondition for the successful introduction of QACP is the commitment
and active support of the senior management. Senior management must also
assume the responsibility for the quality of the product produced. The
introduction of a QACP concept is based on team work. A small group has to
be formed, not more than 3 to 5 people. Representatives from quality control,
production, marketing etc. should be included. It is important to note that
QACP is not only relevant to production and quality control but includes
many other aspects such as marketing, purchasing etc. The group must
appoint a chairman and a secretary. It must be entitled to call upon outside
expertise if such is needed and it must have the means (funds) to do so. The
identification of the product to be studied is one of the first steps to be taken.
In addition, the intended use should be documented. QACP is concerned with
normal conditions of production and handling. Intentional misuse of the
product, tampering and sabotage are not included in the system. Description
of the production line can best be done by preparing a fairly detailed flow-
chart. QA is concerned with functions, not equipment. The risk to be studied
is a compound, substance, material etc. the presence of which can lead to
product spoilage. The HACCP should be restricted to potential public health
hazards. Product spoilage and other quality properties should be excluded. In
addition to the public health aspect, QA is of strictly commercial interest to
the food business operators. Hazards are physical,

TM-00034:21 21
 Introduction of a Quality
Assurance(1)

• Commitment of senior management

• Team work
• Identification of product to be studied
• Description of the production line
• Identification of the risks
– physical,chemical and biological
(to be continued) (be
22
TM-00034:22

chemical or biological by nature. Only one hazard should be studied at a

time. For food commodities in general, and in long-life products specifically,
the number of possible hazards is very large. While QACP is the concern of
the commercial processor only, the HACCP concept must be undertaken in
cooperation with local public health authorities. (to be continued)

Source:BvB Doc

TM-00034:22 22
 Introduction of a QACP Program
(2)
• Hazard Assessment
– probability estimate
– severity estimate
• Identification of control points
• Identification of control parameters

(to be continued)

23
TM-00034:23

Introduction of QACP Program (2)

At this stage, a risk assessment should be made covering the total production
line, from raw material to consumption of the product. The purpose is to
provide a ranking of the importance of the risks in order to permit an optimal
use of available resources for quality improvement. The risk assessment
consist of two steps: probability estimate and severity estimate. By
multiplying the probability estimate and the severity estimate, a number is
obtained which represents a relative estimate of the importance of the risk
under study. The control points are the stations, stages, functions, operations,
processes etc. where control can be executed in order to eliminate a risk or
reduce a risk to an acceptable level. Depending on the complexity of the
technology it may be necessary to identify control parameters as well as for
the production of long-life products. In UHT processing and aseptic
packaging, thermal and chemical processes are used. These have the following
control parameters:
thermal processes: time and temperature
•chemical processes: type of chemical, concentration, contact, contact time,
temperature during contact
Again, at this stage a risk assessment can be undertaken. For each control
point or parameter, the following values should be specified: critical limit
separating acceptability from unacceptability, target value, preventive
measures and corrective actions.
(to be continued)
Source:BvB Doc

TM-00034:23 23
 Introduction of QACP Program
(3)
• Process monitoring and verification
• Validation procedure
• Audit

24
TM-00034:24

Introduction of QACP Program (3)

Process monitoring and verification are procedures which are used to assure
that the processes applied are in agreement with the processes intended.
Such procedures include all kinds of record keeping, supervision,sampling
plans, test methods etc. The personnel responsible for monitoring the control
points, their actual duties, and the persons they must contact if the operation
is out of control, should be identified.
Validation procedures need to be implemented in order to assure that the
proper, intended processing conditions have been adhered to. The US FDA
has defined validation as follows:
“Process validation is establishing documented evidence which provides a
high degree of assurance that a specific process will consistently produce a
product meeting its predetermined specifications and quality attributes”
Once the QACP system has been put into effect, regular internal and external
auditing is necessary. The purpose is to assure that the procedures outlined in
the documentation are generally followed, to include in the documentation
any changes and improvements which might have occurred, to add risks
which might have been overlooked and to inform the senior management
about the progress, short-comings etc. of the implementation.

Source:BvB Doc

TM-00034:24 24
 Quality System

Quality
HACCP/QACP
Assurance

Quality Control
System
Quality System Other Factors ISO 9000

25
TM-00034:25

Quality System
A quality system places considerable demands on management and operative
staff. It is a very complex subject.
The quality of a manufactured product depends on the care which is
exercised from the time of the reception of the raw material until the product
is used by the consumer. To prevent irreversible damage from happening
collaboration is needed between production,quality control, quality assurance
and marketing;in short everybody.
The commitment and support from the senior management is a precondition
for the introduction of any quality system
To this end, training and education of the staff is a must.

Source:BvB Doc

TM-00034:25 25
 Quality System
all quality related aspects should involve

• Senior Management
• Middle Management

26
TM-00034:26

Senior Management
The first task of of the Senior Management is to decide which quality
standards should be implemented. ”An effective quality system should be
designed to satisfy customer needs and expectations while serving to protect
the organisation’s interest. A well structured quality system is a valuable
management resource in the organisation and control of quality in relation to
benefit, cost and risk considerations. The responsibility for, and commitment
to, a quality policy belongs to the highest level of management. Quality
management encompasses all activities that determine the quality policy, its
objective and responsibilities, and its implementation of them by means such
as quality planning, quality control, quality assurance and quality
improvement within the quality system.” The Senior management must also
establish and ensure proper procedures for handling quality policy,
organisation, responsibility and authority, training, resources,
documentation, purchasing, control of inspection, measuring and test
equipment availability, as well as handling, storage, packaging and delivery,
control of non-conforming products, management review, contract review,
auditing of the quality system, and financial considerations of quality systems.

Source:BvB Doc

TM-00034:26 26
 Quality System
all quality related aspects should involve

• Senior Management
• Middle Management

27
TM-00034:27

Middle Management
In addition to the requirements mentioned above, there are essential
requirements for the implementation of any quality system intended for the
production of heat treated foods.
efficient maintenance and operation of processing and ancillary plants
•systematic application of plant and process control procedures
•careful monitoring of the compositional and hygienic quality of the food at
all stages-from the time of reception at the food factory until the time of
consumption.
•

Source:BvB Doc

TM-00034:27 27
 Quality System versus Quality
Control System

Quality System

Quality Control
System

28
TM-00034:28

Comparison of a Quality Control System and a Quality System

Today most enterprises use a combination of both. Quality Controls have
significant limitations. This is especially true for end-product control. While a
quality system requires integration of all quality related aspects quality
control works by establishing sampling points. Quality control activities are
often regarded as “police” actions and everybody likes to fool the police! This
contributes to an often encountered isolation. Competence of the staff and
communication between departments counteract isolation. The key to success
of any quality system is that the senior management accepts the overall
responsibility for product quality. A comparison between a quality control
system and a quality system can be as follows
Quality Control System Quality System
Oriented towards end product Integration of all quality related
control aspects into a quality
assurance system
Quality is achieved by control Quality is produced
Only sections of production are The total production process and
more covered is included
The quality control system is often Quality assurance is always
integrated isolated
Quality control is often viewed as a Communication, training and
police function education results in quality
thinking

Source:BvB Doc

TM-00034:28 28
 Long-life Products
UHT Process
Intermediate
Heating Holding Cooling
Product

Homogeni- Homogeni-
zation zation

Long-Life Aseptic Aseptic Sterile

Product Packaging Transfer Product

Source:BvB Doc
29
TM-00034:29

Long-Life Products
The technology used to produce long-life products implies the separation of
the processes of product sterilisation and packaging. UHT implies rapid
heating and short holding at sterilisation temperature followed by rapid
cooling. If combined with aseptic filling, a long-life product is obtained. A
commercially sterile product is obtained by the UHT treatment. Using aseptic
conditions, this product is transferred to the packaging operation. In order to
maintain a high microbiological quality, packaging has to be done under
aseptic conditions. In indirect UHT equipment, homogenisation may either be
before (upstream) or after (downstream) the actual product
sterilisation.Direct UHT always requires downstream homogenisation.
In order to better understand the different processing steps involved it is
useful to prepare a flow-chart. Functions, rather than equipment, should be
listed.

Source:BvB Doc

TM-00034:29 29
 UHT Process-Control Points and
Parameters
Heating Temperature 135-150°C

UHT
Process

Holding Time 2 to 4 s

Control Point Control Parameter Control Process

Source:BvB Doc

30
TM-00034:30

Control Points and Control Parameters

The UHT process is a control point in the manufacturing of long-life
products. The control parameters should be included in the flow chart.
Usually, sterilisation temperature is automatically controlled by a
thermosensor which has regulating, recording and guarding functions.
However, the pressure drop and the temperature differential, even if
measured, are neither registrated, nor connected to a safe-guarding system.
The sterilisation process of the aseptic transfer line is usually controlled and
guarded by a thermosensor which is placed in the product return line. Often
this operation is also recorded.

Source:BvB Doc

TM-00034:30 30
 UHT Treatment - Control
Process
Automatic
Temperature
Thermosensor

UHT Length
Process Constant

Automatic
Volume of
Time Pressure Drop
Holding Tube
Diameter
Deposit

Homogeniser
Flow Rate Automatic
Constant
Temp Diff

Control Point Control Parameter Control Process

Source:BvB Doc
31
TM-00034:31

Control Process
Usually, sterilisation temperature is automatically controlled by a
thermosensor which has regulating, recording and guarding functions.
However, the pressure drop and the temperature differential, even if
measured, are neither registrated nor connected to a safe-guarding system

Source:BvB Doc

TM-00034:31 31
 UHT Process-Control Points and
Parameters
UHT Reinfection Plant
Process of product sterilization Time

Tempera-
Tightness of Proper ture
the system Cleaning

Cracks&
Gaskets Membranes
pinholes

Control Point Control Parameter Control Process

Source:BvB Doc
32
TM-00034:32

Plant Sterilisation and Tightness of the system

Before the process of product sterilisation starts, the plant must be properly
sterilised. Such a procedure requires proper cleaning of the plant and a
time/temperature treatment. Cleaning of in-flow sterilisation equipment is
done by CIP circulation cleaning. In such a system, the following parameters
are critical: type of detergent, concentration of detergent, time of circulation
and flow rate. Sterilisation of the plant is a time/temperature treatment,
where the time is controlled by a timer which is in turn activated by a
thermosensor. This thermosensor must be placed after the last part of the
production line included in the sterilisation cycle.
The tightness of the system is crucial for its success. Reinfection of a sterilised
product is also possible when there is leakage in the system. Attention needs
to be paid to gaskets, membranes, cracks and pinholes. Tightness control is
the responsibility of a person. The human factor must be considered.

Source:BvB Doc

TM-00034:32 32
 Aseptic Transfer-Control Points
and Parameters
Aseptic Reinfection AT
Transfer of product sterilization Time

Tempera-
Tightness of Proper ture
the system Cleaning

Cracks&
Gaskets Membranes
pinholes

Control Point Control Parameter Control Process

Source:BvB Doc

33
TM-00034:33

Aseptic Transfer
Once sterilised, the product has to be transported under aseptic conditions to
the aseptic filling equipment. Reinfection of the product has to be avoided
and sterilisation and tightness of the system become critical. Sterilisation
requires proper cleaning and a time/temperature treatment. Cleaning of
aseptic transfer equipment is done by CIP circulation cleaning. In such a
system, the following parameters are critical: type of detergent, concentration
of detergent, time of circulation and flow rate. Sterilisation of the plant is a
time/temperature treatment, where the time is controlled by a timer which is
in turn activated by a thermosensor. This thermosensor must be placed after
the last part of the production line which is included in the sterilisation cycle.
The tightness of the system is crucial for its success. Reinfection of a sterilised
product is also possible when there is leakage in the system. Attention needs
to be paid to gaskets, membranes, cracks and pinholes. Tightness control is
the responsibility of a person. The human factor must be considered. Some
plants incorporate steam barriers into the aseptic transfer system, especially
if a sterile tank is part of the transfer line. Proper functioning of the steam
barriers should be controlled by thermosensors and/or inspection by the
machine operator.

Source:BvB Doc

TM-00034:33 33
 Aseptic Transfer-
Sterlization Control
Cleaning Unit Cleaning Unit

UHT Sterilizer Piping Aseptic Tank Piping Aseptic Filling

Automatic Automatic
Thermosensor Thermosensor

Return Line Return Line

Automatic Automatic
Timer Timer
Source:BvB Doc

34
TM-00034:34

Aseptic Transfer-Control of the Line Sterilisation Process

The sterilisation process of the aseptic transfer line is usually controlled and
safe-guarded by a thermosensor placed in the product return line. Often this
operation is also recorded.

Source:BvB Doc

TM-00034:34 34
 Aseptic Packaging System
TBA/8,TBA/9,TBA/19 and TBA/21
LS - Strip

Packaging Packaging
Mtrl Heating
Steam Mtrl
Sterilization

H202 H202
Sterile Sterile
Sterilization
Surrounding Product
Warm Air

Maintaining
Hot and Dry
Air
Sterility Tight
Packages

Steam Barrier Sterile Air Long-LIfe

Products

Source:BvB Doc
Control Point Control Parameter Control Process
35
TM-00034:35

Control Points in TBA/8,TBA/9,TBA/19 and TBA/21

For TBA/8 and TBA/9 control points are the packaging material
sterilisation, sterile surrounding where the packages are formed and the
production of tight packages.

Source:BvB Doc

TM-00034:35 35
 Packaging Material Sterilization
Control Points and Parameters
TBA/8,TBA/9,TBA/19 and TBA/21
Packaging Mtrl
Sterilization

Contact
Chemical Concentration Contact Contact Time
Temperature

30 to 50% Dip-In 6.4 s 65°C

Control Point Control Parameter Control Process

Source:BvB Doc
36
TM-00034:36

Packaging Material Sterilisation - Control Points and Control

Parameters
The packaging material sterilisation is a chemical process which has five
control parameters; the chemical used, the concentration of the chemical, the
contact between the chemical and the packaging material, the contact time
and the temperature during contact. In order to assure continuity of the
packaging material sterilisation process, suitable control procedures must be
applied. The type of chemical is not controlled by the commercial processor
who must rely on certification, i.e. the reliability of the supplier. The
concentration is measured either by the machine operator or by laboratory
staff, usually only at the beginning of the packaging operation. The
consumption of hydrogen peroxide should be determined by the machine
operator either at the end of the production run or, preferably, at regular
intervals. The contact time is a function of the packaging material and the
machine design and consequently, constant: no control is needed. The
temperature during contact is achieved by the peroxide bath, which in turn is
controlled by a thermosensor which has a regulating and a safe-guarding
function.

Source:BvB Doc
TM-00034:36 36
 Sterile Surroundings-Control Points and
Parameters TBA/8,TBA/9,TBA/19 and
TBA/21
Time

Sterile
Surrounding
Sterilization Steam Temperature

Time
Maintaining Hydrogen
Sterility Peroxide

Temperature

Sterile Air
Chemical Concentration Contact
Overpressure

Time

Hot,dry Air
Holding Time Holding Time Air Flow
Temperature

Source:BvB Doc
Control Point Control Parameter Control Process
37
TM-00034:37

Sterile Surroundings - Control Points and Control Parameters

The area in which the packages are formed, filled and sealed must be
sterilised prior to production start and sterility must be maintained during
the entire production rune. These process steps involve a number of control
points and control parameters. Continuity of equipment sterilisation
operation in general requires that all surfaces are free from residues, that
they are clean.This is true particularly if the process of sterilisation is
chemical in nature. Sterilisation of the area in which the packages are
formed, filled and sealed is done by both thermal and chemical processes. In
this processing stage a number of control parameters are involved.. Process
control is also required in order to assure that the equipment sterilisation
process is repeatable.

Source:BvB Doc

TM-00034:37 37
 Maintaining Sterility -Control Points and
Parameters TBA/8,TBA/9,TBA/19 and
TBA/21
Machine
Time
Design

Air Automatic
Temperature Thermosensor
Sterilisation

Maintaining Sterile Air

Sterility Overpressure
Automatic
Overpressure Compressor
Manometer

Air Flow
Constant
Constant

Control Point Control Parameter Control Process

Source:BvB Doc 38
TM-00034:38

Maintaining Sterility during Production Control and the Process

During the process, sterility has to be maintained in the area where the
packages are formed, filled and sealed. The control function is essential for
the safety and adequacy of the operation.

Source:BvB Doc

TM-00034:38 38
39