Dairy Establishment Inspection Manual – Chapter 14 - Aseptic Processing and Packaging Systems
1.14.18 Aseptic Packaging

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Aseptic packaging has been defined as a procedure consisting of sterilization of the packaging material or container, filling with a commercially sterile product in a sterile environment, and producing containers that are tight enough to prevent recontamination i.e. which are hermetically sealed.

UHT of product

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Aseptic transfer
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sterilization of packaging material, sterile surroundings during packaging
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tight containers

Aseptically packaged UHT milk must also give almost complete protection against light and atmospheric oxygen. The package must therefore be of barrier type or similar.

The term aseptic implies the absence of any unwanted organisms from the product, package or other specific areas. The term hermetic is used to indicate suitable mechanical properties to exclude the entry of bacteria into the package or, more specifically, to prevent the passage of microorganisms and gas or vapour into or from the container.

Packaging Conditions

1.14.18.01 Packaging Material

An appropriate program must be established by the processor to ensure that the packaging materials received are in compliance with the requirements identified in the scheduled process. These procedures should include visual examination of the packaging material to identify damage and defects. All packaging material shall be stored in a clean and sanitary manner to minimize the risk of contamination and physically damaging the materials.

1.14.18.02 Sterilant

The aseptic packaging machine must ensure the sterilization of the container and provide a sterile environment for filling. The most commonly used sterilants, depending on the application, are hydrogen peroxide (H2O2) or a combination of H2O2 and peracetic acid. During the sterilization of the packaging material by H2O2 or other sterilants, a residue of these sterilants may be left on the material. Testing of the residue must be performed at an appropriate frequency and must be at or below the level specified by the scheduled process. Sterilants used to sterilize the package shall be dairy safe and approved for dairy plant purposes. If dilution is required, sterilants must be diluted as per manufacturer's recommendation.

Two important factors must be considered when using sterilants, these are (Long-Life Products: Heat-Treated Aseptically Packed - A Guide to Quality. Von Bockelmann et al. 1998):

  1. Microbiological efficiency of the sterilization process
  2. Elimination of chemical residues from the package which can subsequently contaminate the filled product

Depending on the type of packaging equipment, different means of applying the sterilants can be used e.g., spray, vapour, roller system, immersion bath etc. Other systems may be acceptable if the Process Authority proves that these sterilants meet Health Canada's requirements for commercial sterility.

Plastic bottle sterilization: in general, plastic bottles are sterilized using a solution of H2O2 and peracetic acid. The bottles are filled with the solution of chemical sterilant while passing on a conveyor for a pre-determined contact time, then they are inverted to empty the solution followed by a sterile water rinse to eliminate any chemical residual in the package prior to filling. (Refer to Appendix 19 - 12 B for sterile water requirements)

1.14.18.03 Headspace Gas

Some processors use nitrogen gas or other media to create a headspace in the formed package. The nitrogen gas or any other media used must be filtered or treated in other ways to remove or destroy microorganisms.

1.14.18.04 Packaging/Filling Room Air Quality

In order to minimize contamination from other areas of the processing plant, the packaging/filling aseptic zone must be under positive pressure, relative to the rest of the plant. However, the room must be under negative pressure relative to the aseptic zone of the packaging machine. Microbial analysis of air quality should be conducted on a specified time frame adequate enough to substantiate the air quality is acceptable and records of results are kept in the plant's file.

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