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Whole Package Integrity

The Whole Package Integrity test is intended to determine package integrity of a finished product package. This includes a whole package microbial challenge and subsequent sterility testing on the packaged product to determine penetration of the indicator organism used. Materials tested include pouches, trays, syringes, IV bags, tubing sets, vials, and containers.

The Whole Package Integrity test meets the requirements outlined in ISO 11607 for microbial barrier testing.

Applicable Standards

  • ISO 11607
  • AAMI TIR17
  • PDA Technical Report 27

Testing Locations

Study Outline

The Whole Package test procedure involves aerosolizing a high number of Bacillus atrophaeus spores with a particle size of 4.5 microns or smaller and then testing the contents of the package for ingression of that organism. Occasionally, a product such as a syringe or bottle is filled with a broth medium prior to the challenge. Following the aerosol challenge, the product/simulated product is tested with soybean casein digest broth. The media is then incubated and scored for the presence of the challenge organism.

Please see our Packaging Validation matrix for more information.

Sample size required: Complete sterilized packages

Recommended replicates: Sample size is at the discretion of the sponsor depending on your statistical analysis (risk, production, and cost).

The packages must come sterilized.

If you have additional questions about Whole Package Integrity testing services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.