Dairy Establishment Inspection Manual – Chapter 14 - Aseptic Processing and Packaging Systems
1.14.20 Quality Control

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Each processing establishment must have a quality control program of the processes used as well as the products packaged. The tests and frequency of this program may vary with the food product as well as the needs of the regulator and establishment, but must be done in such a manner and at a statistically valid frequency that provides a high level of assurance that the finished product is commercially sterile.

1.14.20.01 Finished Product Testing

Sampling Plan: Statistically valid samples of the production must be taken to assess the safety and quality of the product. The quantity of containers to be taken, the tests to be performed and the standards to be met should be determined for each plan of the sampling program, based upon specifications supplied by the processing authority.

Inspection of heat seals: Appropriate inspections and tests must be conducted by trained personnel before production starts and during production, after jam-ups and as per manufacturer's recommendation. Inspection of seals must be done at intervals of sufficient frequency to ensure consistent and reliable hermetic sealing as per manufacturer's recommendation.

In general, tests can be divided into two main types:

  1. Non-destructive testing: visual inspection of seals for absence of voids, wrinkles, pleats. Other important checks to be performed include seal alignment, overlap, product contamination in seals, de-lamination, etc.
  2. Destructive testing: activation pattern using a polarisation filter, vacuum bubble test, conductivity/electrolytic test, dye penetration test, microbial challenge test, storage and distribution test, burst test, removal torque test, seal security/seal strength tests, etc.

The methods used for these inspections must be those specified by the packaging material supplier.

Incubation: Incubation tests must be done at a statistically valid frequency to verify the "commercial sterility" of the finished product. Samples are generally incubated at a specified temperature for a specific period of time to detect mesophilic growth. Incubated packages are observed for any sign of gas production (puffers), product changes such as odour, pH, oxygen content, viscosity and other indicators of spoilage, such as separation or curdling.

Microbial Evaluation: Microbial analysis for commercial sterility must be conducted on a statistically valid number of containers from each lot (from each filling head) regardless of the absence of signs of non-sterility following incubation.

Microbial growth from unsterile containers must be further investigated and the action taken recorded. Pending the outcome of the investigation, the lot must be detained.

Product Release: All package integrity, incubation testing, processing record review and the investigation of any process deviations must be satisfactory before the product is released for distribution.

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