Preservation Efficacy Test (PET), "Challenge Testing"

Challenge Testing for Pharmaceutical ProductsThe Challenge Testing for Pharmaceutical products, also known as "Preservation Efficacy Testing - PET" is in the scope of the laboratory's ISO 17025 accreditation.
Pharmaceutical products should be tested during pharmaceutical product development for adequacy of preservation against microbial contamination.

The QACS Laboratory offers contract laboratory services to the Pharmaceuticals industry. The Challenge Testing for Pharmaceutical products, the Preservation Efficacy Testing (PET), should be conducted to substantiate the adequacy of preservation against microbial contamination which may occur under reasonably foreseeable conditions of storage and use.

EP protocol
The test consists of challenging the preparation, wherever possible in its final container, with a prescribed inoculum of suitable micro-organisms, (Pseudomonas aeruginosa, Staph. aureus, E. coli, Candida albicans, Aspergilus brasiliensis) storing the inoculated preparation at a prescribed temperature, withdrawing samples from the container at specified intervals of time and counting the organisms in the samples so removed. The preservative properties of the preparation are adequate if, in the conditions of the test, there is a significant fall or no increase, as appropriate, in the number of micro-organisms in the inoculated preparation after the times and at the temperatures prescribed. Results are available within 35 days. Min sample quantity is 100g.

GLP compliance
The QACS laboratory has received EU-GMP certification from 2009 by the National Organization for Medicines (NOM/EOF) for microbiological testing (non-sterility) for human and veterinary medicinal products for various dosage forms. EUDRA GMDP Key: 7737

Real time reporting
Preliminary reports are communicated on intermediate readings.

Our experienced scientists are ready to help determine the best and most cost effective pharmaceutical challenge testing for your needs. We also offer a 24h courier transport service for EU based clients. Request more information or pricing list and see how our team can help you with challenge testing for pharmaceutical products.