Aseptic Terminology

ABMI

ABMI
Symposium [June 2008]

ASEPTIC TERMINOLOGY

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

ABMI

CONTENTS

Purpose of TC Aseptic Terminology Aseptic Definitions Initial Bioburden of Packaging Material Test Spores Recommendation for Inoculation Techniques Summary

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

ABMI

PURPOSE OF TC "ASEPTIC TERMINOLOGY"

PURPOS E T o es tablis h c ommon definitions and rules T o c reate a c ommonly elaborated rec ommendation for validation T o be able to ac hieve the targ et of validating a line ac c ording to a predetermined s c hedule with a predetermined proc edure T o inc reas e s afety on both s ides in the interes t of the c ons umer

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

ABMI

DEFINITIONS I
We agree on aseptic filling in contrast to hot filling and call it ASEPTIC FILLING
Cold Aseptic Filling Aseptic Cold Filling Aseptic Filling

This technology is the technical precondition which allows aseptic filling of microbiologically sensitive beverages In the process, a pasteurized, sterilized or aseptically filtered product is filled contamination-free into sterilized containers and sealed When sealed in this procedure, the finished packs have permanent microbiological stability
Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

ABMI

ASEPTIC DEFINITIONS - PART I

ASEPTIC PROCESS

From Greek, meaning "uncontaminated". An aseptic process which produces a shelf stable product free from microbial contamination to allow distribution without any further usage of chemical preservatives. Removal of macroscopically identifiable contamination such as food residues, deposits, dust, etc. Proper cleaning eliminates the nutritive medium for microorganisms and is a prerequisite for proper disinfection or sterilization. Commercial sterility of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution. (source: FDA)
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CLEANING

COMMERCIAL STERILITY

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

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ASEPTIC DEFINITIONS - PART II

CONTAMINATION

Product, media or surfaces are contaminated if contaminants (including microbes) can be identified on or in them. The term contamination describes the addition of contaminants. Inactivation of all pathogenic and product-damaging microbes to a level that complies with the respective hygiene requirements. Germs are microorganisms and their spores that can multiply under the current, unchanged conditions (i.e. "germinate"). A product is germ-free, if it does not contain any microorganisms that are viable in the respective product (also, beverage-sterile, commercially sterile).

DISINFECTION

GERMS

GERM-FREE

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

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ASEPTIC DEFINITIONS - PART III

MICROBIOLOGICAL CONTAMINANTS

Contaminants are defined as microbes present at a particular location or within a medium where they are undesired at a particular time. Sum of negative, visually and sensorically identifiable changes in food, caused by multiplication of microorganisms and their metabolic activity. Here: independently viable organisms that can be classified in the following three groups: bacteria, moulds, yeasts.

MICROBIOLOGICAL SPOILAGE

MICROORGANISMS

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

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ASEPTIC DEFINITIONS - PART IV

PASTEURISATION

The act or process of heating a beverage moderately to a specific temperature for a specific period of time in order to kill microorganisms that could cause disease, spoilage, or undesired fermentation. Products, media, or surfaces are sterile if no viable microorganisms can be identified. Destruction or removal of microorganisms, including bacterial spores, present in food products or on surfaces.

STERILE

STERILISATION

The definitions are integrated into the glossary of the ABMI homepage.

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

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ASEPTIC PHILOSOPHY FOR INCREASED PRODUCT SAFETY

Every aseptic process follows the rules of statistics The higher the incoming bioburden the higher the risk of contamination
The less comes in the less we have to deal with

Two ways out: Increase decontamination performance Decrease incoming bioburden Limiting the incoming bioburden is the preferred way to the future

Germ content

Initial bioburden

Decontamination rate (function of price)

Failure rate

time
Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Aseptic Terminology

ABMI

INITIAL BIOBURDEN OF PACKAGING MATERIAL

Preform: Preforms do in general have a good hygiene level depending on storage conditions. With GMP it is easy to keep the hygiene of the preform at a level below 10 cfu/preform as a mean value. The absolute maximum shall not be above 50 cfu/preform. The complete preform is checked. Sampling point is at the infeed to the blow-moulding machine. Bottle: Bottles do in general have a good hygiene level depending on storage conditions of the preforms and on the hygiene of the blow moulder. With GMP it is easy to keep the hygiene of the bottle at a level below 20 cfu/ bottle as a mean value. The absolute maximum shall not be above 100 cfu/ bottle. Ideally the complete bottle is checked. If only the inside is checked, 10 cfu/botte and 50cfu/bottle apply. Sampling point is at the infeed to the bottle steriliser.

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

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Aseptic Terminology

ABMI

INITIAL BIOBURDEN OF PACKAGING MATERIAL

Flat caps: For flat caps an initial bioburden of below 10 cfu/cap as a mean value is acceptable. The absolute maximum shall not be above 50 cfu/cap. Sampling point is at the infeed to the cap steriliser. Chemically sterilisable sports caps: For these sports caps an initial bioburden of below 10 cfu/cap as a mean value is acceptable. The absolute maximum shall not be above 50 cfu/cap. Only the reachable parts of the surfaces are checked. Sampling point is at the infeed to the cap steriliser.

Non chemically sterilisable sports caps: For these sports caps preirradiation is required. The treatment has to ensure commercial sterility and food safety requirements. The physical performance of the cap must not be affected. Sampling point is at the infeed to the sorter.

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

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Aseptic Terminology

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TEST SPORES

Spores of Bacillus atrophaeus ATCC 9372 are recommended for PAA and H2O2 systems. More used for Low Acid products and surface decontamination trials.

Spores of Aspergillus niger ATCC 16404 are recommended for PAA, H2O2 and UV-light systems. Mostly used as the mould reference in the industry. More dedicated for High Acid products and some dairies.

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

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Aseptic Terminology

ABMI

RECOMMENDATION FOR INOCULATION TECHNIQUES

Spray inoculation Preform externally Preform internally Bottle externally Bottle internally Cap externally Cap internally Strips
Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008

Single dot inoculation

Multi dot inoculation X

Shaking or beating

X X X X X X
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Still in progress

Aseptic Terminology

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Thank you!

Author: Dr. Sven Fischer, Krones AG (TC-Leader) Date: 23/06/2008