News
20.06.2023 - Pharmacy
Testing for Adequate Antimicrobial Preservation of Medicinal Products - Preservative Efficacy Test – European Pharmacopoeia 5.1.3
The Preservative Efficacy Test (abbreviated: PET, Challenge Test) must be carried out for all aqueous pharmaceuticals in accordance with the European Pharmacopoeia, current version, chapter 5.1.3. This test proves the microbiological stability of a product and simulates contamination with selected test microorganisms.
Even for products where a PET can be omitted through risk assessment, contamination and infections can occur in the end user due to improper use or storage. Therefore, a microbiological risk assessment and analytical control is always necessary.
Contact us to find suitable methods and make your products microbiologically safe.
Literature:
· Microbiology of Non-Sterile Pharmaceuticals - An Overview Part 2
· www.pharmazeutische-zeitung.de
· European Pharmacopoeia, current version, chapter 5.1.3, test for adequate antimicrobial preservation