Further Processing Code of Practice - Home | MPI

1 Further Processing code of Practice Part 3: good Operating Practice July 2009 Page 1 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Prelims Prelims Amendment 0 July 2009 Table of Contents Prelims 1 1 Heat Treatment 3 2 Commercial Sterilisation 4 Purpose and Scope ..4 Definitions ..4 Regulatory Requirements ..6 Procedures (for compliance) ..6 References: ..28 3 Concentration and Drying 30 Purpose and Scope ..30 Definitions ..31 Regulatory Requirements ..31 Procedures (for compliance) ..32 References ..40 4 Hurdle Technology 42 Purpose and Scope ..42 Definitions ..42 Regulatory Requirements ..42 Procedures (for compliance) ..43 References ..50 5 Smoking 51 Purpose and Scope ..51 Definitions ..52 Regulatory Requirements ..52 Procedures (for compliance).

2 52 References ..61 6 Acidification 63 Purpose and Scope ..63 Definitions ..63 Regulatory Requirements ..64 Procedures (for compliance) ..64 July 2009 Page 2 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Prelims References ..70 7 High Pressure Processing 71 Purpose and Scope ..71 Definitions ..71 Regulatory Requirements ..72 Procedures (for compliance) ..72 References ..82 July 2009 Page 3 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Heat Treatment 1 Heat Treatment pending July 2009 Page 4 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Commercial Sterilisation 2 Commercial Sterilisation Purpose and Scope This section contains the requirements for the commercial sterilisation of low acid canned foods.

3 The term canned includes rigid, semi-rigid and flexible packaging options. This section does not apply to aseptic Processing Ultra High Temperature Processing (UHT). Production of commercially sterile product is dependent on three key conditions: sealing of the container in such a manner that microorganisms cannot re-enter and contaminate sterilised product; application of heat to the product for a time and at a temperature sufficient to produce commercial sterility; proper post-process handling procedures that protect the finished closures from damage, which could cause leakage or post-process contamination. Definitions Come up time is the time which elapses between the introduction of steam to the retort and the time the retort reaches the specified Processing temperature. Commercial sterilisation means the condition achieved by application of heat, sufficient alone or in combination with other appropriate treatments to render the product free of microorganisms capable of growing under normal non-refrigerated conditions at which the product is likely to be held during distribution and storage.

4 Critical failure in relation to container closures means anything that would affect the subsequent integrity of the container. F0 is a measure of the amount of lethal heat which results from a specified thermal process (usually measured at the point of lowest lethality in the container). The number is the lethal effect equivalent to the number of minutes at C when assuming instantaneous heating and cooling and a z value of 10 C. Flexible container is a container where its shape or contour is affected by the enclosed product ( retort pouches). Headspace means the volume in a container not occupied by the product. July 2009 Page 5 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Commercial Sterilisation Heat-penetration tests means the scientific experiments conducted to determine heating and cooling behaviour of a product/package combination, processed in a specific retort system, in order to establish safe thermal processes that will result in commercially sterile product or to evaluate process deviations.

5 Heat Processing time means the time that the sealed containers are held at the specified Processing temperature. Hermetically sealed means air tight, completely sealed and impermeable to gas. Initial temperature (IT) means the average temperature of the contents of the coldest container to be retorted when the heat Processing begins, at the start of the come-up time and is usually the first container to be prepared for Processing . Leaker means a sealed and heat processed container which has a defect that allows the passage of water, gas or microbes into the container. Lethality means the effect of exposure to time and temperature transformed mathematically to give a measure of the sterilisation achieved (summed values usually being expressed as F or F0). Minimum initial temperature means the lowest initial product temperature in a container specified in the scheduled process that the process has been developed for.

6 Operator in relation to an animal product business means the owner or other person in control of the business. Qualified canner means a person who meets the competency specification set out in clause 25(2) of the Animal Products (Specifications for Products Intended for Human Consumption) Notice 2004. Retort means a pressure vessel, designed for heat Processing product packed in hermetically sealed containers. Rigid container is a container where its shape or contour is neither affected by the enclosed product nor deformed by an external mechanical pressure of up to (10psig) ( cans, glass jars). Saturated steam means pure steam in equilibrium with water at the same temperature. Under these conditions, the temperature of the steam is entirely dependent on its pressure. Scheduled process means the thermal process alone or in combination with critical factors, and verified by an independent qualified canner, for a given product formulation, container type and size and thermal Processing system to achieve commercial sterility of the product.

7 July 2009 Page 6 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Commercial Sterilisation Semi-rigid container is a container where its shape or contour is not affected by the enclosed product under normal atmospheric temperature and pressure but can be deformed by an external mechanical pressure of less than (10 psig) ( tetra-bricks, pottles). Temperature-distribution study are scientific experiments conducted to determine the time, temperature or other parameters that must be met to ensure uniform temperature is established in the retort system. Vacuum means the negative internal pressure in the container produced during the seaming process. Venting means flushing air out of steam retorts at the beginning of a heat process. It is done by allowing large volumes of steam to flow through the retort to drive and carry air out through open vents in the retort.

8 Z value is a measure of the temperature resistance of the target microorganism, the temperature change required to effect a tenfold change in the rate of microbial destruction. Regulatory Requirements Refer to Part 2 for the specific legal requirements that apply to commercial sterilisation. Procedures (for compliance) General The operator must document procedures for the commercial sterilisation of low acid canned products which complies with the principles detailed in one of the following codes: a. the Recommended International code of Hygiene Practice for Low-acid and Acidified Low-acid Canned Foods, as published by the Codex Alimentarius Commission: b. the United States Food and Drug Administration Requirements for Thermally Processed Low-acid Foods Packaged in Hermetically Sealed Containers, as contained in 21 CFR Part 113, and Acidified Foods as contained in 21 CFR Part 114, as appropriate: c.

9 The code of Practice for the Thermal Processing of Low-acid Canned Food, as published by the Australian National Health and Medical Research Council. July 2009 Page 7 Amendment 1 Further Processing code of Practice Part 3: good Operating Practice Commercial Sterilisation Outcome of Commercial Sterilisation The operator must ensure that an F0 of 3 or greater is achieved in the product, unless full scientific justification for a lower F0 has been validated in the risk management programme. The operator must ensure the inhibition or inactivation of spoilage organisms capable of growing under normal non-refrigerated conditions at which the product is likely to be held during distribution and storage during its shelf life. The operator must document any regulatory limits that are appropriate for the product.

10 There are currently no regulatory limits for commercially sterilised products. The operator must establish and document operator-defined limits for the product. Operator-defined limits are additional measurable limits that are established by the operator and are not defined in legislation. Operator-defined limits may be expressed as a: i. product requirement, microbiological limit; ii. process parameter, minimum time temperature combination; iii. performance criteria, 12D reduction in pathogen. They may be taken from sources such as reputable COPs, peer-reviewed scientific information, predictive models, scientific information from a person or organisation known to be competent, or developed from the Operator s own trials and experiments. The minimum F0 to be achieved for each commercially sterile product needs to be specified as an operator defined limit in the risk management programme.