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Quality Assurance

to prevent any deviation from stated quality specifications quality specifications should be integrated

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TM-00034:1

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TM-00033:3

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TM-00033:4


parameters and aspects

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TM-00033:5

( at 30) (TSC) (TRSC) <100 000/ml* <400 000/ml** <100cfu/ml <10cfu/ml

* **
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TM-00033:9

UHT
etc. pH etc.
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TM-00033:10

Source:Eurocitrus
TM-00033:12




Source:Eurocitrus
TM-00033:13

Instruments used for oBrix measurements

Source: Beverage Technology, TP 10 TTC


TM-00033:14

Quality Control Methods


Tomato
Brix Bostwick Viscosity Blotter Howard Mould Count Colour Drain Weight

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TM-00033:15

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TM-00033:17


AQL
AQL 1:100 100000/ml 1:100 10000/ml 0 1:100 1000/ml 00 1:100 100/ml 000 Action Goal

10000/ml <1000/ml 1000/ml 100/ml 10/ml <100/ml <10/ml <1/ml

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TM-00033:18

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TM-00033:19

Departments involved in QA
Quality control Production Maintenance Marketing Senior management

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TM-00034:2

ISO 9000, GMP, QACP and HACCP


ISO 9000 GMP

QACP

HACCP

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TM-00034:4

ISO 9000
Quality Manual Quality Procedures Work Instructions

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TM-00034:5

Good Manufacturing Practices


should be in writing legislation on GMPs co-operation between legislator and industry process control emergency program
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TM-00034:6

Quality Assurance

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TM-00034:7

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

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TM-00034:8

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

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TM-00034:9

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
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TM-00034:10

HAZARDS
Biological : Pathogenic micro-organisms ex. Salmonella sp., Staphylococcus aureus Residues of agents ex. cleaning/ disinfection/ sterilizing, pesticides, allergens, veterinary residues, packaging migration etc. Foreign materials ex. screws, nuts, glass etc.
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TM-00034:11

Chemical :

Physical :

HACCP GOALS
SAFE PROCESS COMPETITION INCREASED CONFIDENCE COST EFFICIENCY DECREASED QUALITY DEVIATION

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TM-00034:12

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

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TM-00034:13

HACCP

END PRODUCT

HAZARD ANALYSIS

Raw material

Processing

Aseptic Transfer

Packaging

Storage & Distribution

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TM-00034:14

HACCP
Raw Material Processing

END PRODUCT
Aseptic Transfer Packaging Storage& Distribution

HACCP

- PATHOGENS - CHEMICAL POLLUTION - FOREIGN SUBTANCES

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TM-00034:15

HACCP
Raw Material Processing

END PRODUCT
Aseptic Transfer Packaging Storage& Distributio n

Preparation Sterilisation

PATHOGENS CHEMICAL POLLUTION

Production Cleaning No Production


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TM-00034:16

FOREIGN SUBTANCES

HACCP
Raw Material Processing

END PRODUCT
Aseptic Transfer Packaging Storage& Distribution

Risk Identification

Critical Control Points


Critical Limits Supervision Corrective Action Documentation Verification

PATHOGENS CHEMICAL POLLUTION

FOREIGN SUBTANSCES

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TM-00034:17

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
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TM-00034:19

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

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TM-00034:20

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)

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TM-00034:21

Introduction of a QACP Program (2)


Hazard Assessment
probability estimate severity estimate

Identification of control points Identification of control parameters


(to be continued)

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TM-00034:23

Introduction of QACP Program (3)


Process monitoring and verification Validation procedure Audit

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TM-00034:24

Quality System
Quality Assurance HACCP/QACP

Quality Control System

Quality System

Other Factors

ISO 9000

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TM-00034:25

Quality System
all quality related aspects should involve Senior Management Middle Management

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TM-00034:26

Quality System
all quality related aspects should involve Senior Management Middle Management

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TM-00034:27

Quality System versus Quality Control System


Quality System

Quality Control System


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TM-00034:28

Long-life Products UHT Process


Intermediate Product Heating Holding Cooling

Homogenization

Homogenization

Long-Life Product

Aseptic Packaging

Aseptic Transfer

Sterile Product

Source:BvB Doc

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TM-00034:29

UHT Process-Control Points and Parameters


Heating UHT Process Holding Time 2 to 4 s Temperature 135-150C

Control Point

Control Parameter

Control Process
Source:BvB Doc

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TM-00034:30

UHT Treatment - Control Process


Temperature UHT Process Volume of Holding Tube Diameter Deposit Automatic Thermosensor Length Constant Automatic Pressure Drop

Time

Flow Rate

Homogeniser Constant

Automatic Temp Diff

Control Point

Control Parameter

Control Process

Source:BvB Doc
TM-00034:31

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UHT Process-Control Points and Parameters


UHT Process Reinfection of product Plant sterilization Time Temperature

Tightness of the system

Proper Cleaning

Gaskets

Membranes

Cracks& pinholes

Control Point

Control Parameter

Control Process
Source:BvB Doc

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TM-00034:32

Aseptic Transfer-Control Points and Parameters


Aseptic Transfer Reinfection of product AT sterilization Time Temperature

Tightness of the system

Proper Cleaning

Gaskets

Membranes

Cracks& pinholes

Control Point

Control Parameter

Control Process
Source:BvB Doc

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TM-00034:33

Aseptic TransferSterlization Control


Cleaning Unit Cleaning Unit

UHT Sterilizer

Piping

Aseptic Tank

Piping

Aseptic Filling

Automatic Thermosensor Return Line

Automatic Thermosensor Return Line

Automatic Timer

Automatic Timer

Source:BvB Doc

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TM-00034:34

Aseptic Packaging System TBA/8,TBA/9,TBA/19 and TBA/21


LS - Strip

Steam

Packaging Mtrl Sterilization

Heating

Packaging Mtrl

H202 Sterilization Warm Air

Sterile Surrounding

H202 Sterile Product

Hot and Dry Air

Maintaining Sterility

Tight Packages

Steam Barrier

Sterile Air

Long-LIfe Products

Source:BvB Doc
Control Point Control Parameter Control Process

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TM-00034:35

Packaging Material Sterilization Control Points and Parameters TBA/8,TBA/9,TBA/19 and TBA/21
Packaging Mtrl Sterilization

Chemical

Concentration

Contact

Contact Time

Contact Temperature

30 to 50%

Dip-In

6.4 s

65C

Control Point

Control Parameter

Control Process Source:BvB Doc

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TM-00034:36

Sterile Surroundings-Control Points and Parameters TBA/8,TBA/9,TBA/19 and TBA/21


Time

Sterile Surrounding

Sterilization

Steam

Temperature

Maintaining Sterility

Time Hydrogen Peroxide

Temperature
Sterile Air Overpressure

Chemical

Concentration

Contact

Time Hot,dry Air

Holding Time Holding Time

Air Flow

Temperature

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

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Maintaining Sterility -Control Points and Parameters TBA/8,TBA/9,TBA/19 and TBA/21


Time

Machine Design

Air Sterilisation Maintaining Sterility Sterile Air Overpressure Overpressure

Temperature

Automatic Thermosensor

Compressor

Automatic Manometer

Constant

Air Flow Constant

Control Point

Control Parameter

Control Process

Source:BvB Doc
TM-00034:38

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