What are the main differences between the preservative efficacy tests according to Ph.Eur. Chapter 5.1.3 and ISO 11930

What are the main differences between the preservative efficacy tests according to Ph.Eur. Chapter 5.1.3 and ISO 11930

What are the main differences between the preservative efficacy tests according to Ph.Eur. Chapter 5.1.3 and ISO 11930

Go back

The two variants of the preservative efficacy test differ in some aspects of the methods and assessment criteria. For implementation according to ISO 11930, the following applies:

  • the microbial status of the product must be checked before implementation
  • Escherichia coli is required as an additional test organism
  • a different nutrient medium (Potato Dextrose Agar) is prescribed for Aspergillus brasiliensis
  • the procedures for preparing the microorganism cultures are newly regulated
  • there are no requirements for microbial reduction after 2 days
  • there are different requirements for the yeast Candida albicans and the mold Aspergillus brasiliensis
  • a margin of 0.5 log levels is permissible to account for measurement uncertainty
  • Criterion A and B no longer have the same significance

Further information on the two types of challenge tests can be found in the BAV Newsletter Cosmetics Part 3 (available at https://www.bav-institut.de/files/newsletters/Sondernewsletter-Kosmetik-Teil-3-in-2013.pdf ).