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Whole Package Integrity Test

Whole Package Integrity Test

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 and vials.

The Whole Package Integrity test meets the requirements outlined in ISO 11607 for microbial barrier testing. Nelson Laboratories uses a custom-designed chamber to challenge the product and uses a test method developed by Dr. Nelson.

Applicable Standards

  • ISO 11607
  • AAMI TIR 17
  • PDA Technical Report 27

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
PKG315 Packaging: Whole Package Integrity (Microbial), Initial chamber run 21 Add
PKG320 Packaging: Whole Package Integrity (Microbial), add. runs 28 Add
PKG315 - Packaging: Whole Package Integrity (Microbial), Initial chamber run
TAT: 21 days
PKG320 - Packaging: Whole Package Integrity (Microbial), add. runs
TAT: 28 days

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: We recommend 60 test samples plus controls based on an AOAC disinfection study to obtain a 95% confidence level. Sample size is at the discretion of the sponsor depending on your statistical analysis (risk, production and cost). If a product is too expensive to permit 60+ samples, dummy parts can be used in place of the product.

The packages must come sterilized.

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