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What is Preservative Efficacy Testing?

Preservative Efficacy Testing is the antimicrobial efficacy of a preservative substance added to a finished product formulation. It is common for a preservative to be added to a finished product to offer an enhanced level of microbiological control over time. The objective of PET is to ensure that this level of control is maintained over the required period of time.

Why do we do it?

Preservative Efficacy Testing is a requirement for products which contain an added preservative. Guidelines for compliance surrounding this can be found in the following pharmacopoeial chapters:

  • Ph. Eur. Chapter 5.1.3
  • USP Chapter 51

This ensures the level of microbiological control appropriate to the route of administration of the product.

How can we help assure compliance?

Honeyman is fully equipped to perform cGMP PET in accordance with the with Ph. Eur and USP specification. We are able to provide:

  • Full scope of method development specific to your product
  • All associated neutralisation validation
  • Full Preservative Efficacy test in accordance with desired specification

Based on the category of the product (category is determined by administration route) the level of bacterial control in a product is assessed at set time points defined in the pharmacopoeias. The product must then show a sustained/reduced level of microbiological control typically over a period of 7 days.

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