Class D Clean Room Environment now available for Sterility Testing
The sterility of a pharmaceutical product is defined by the absence of viable and actively multiplying micro-organisms when tested in specified culture media. Sterility testing is performed on the end product and is one of the quality control tests specified for release of a batch of sterile product.
The new 22 Sq meter Sterility Suite offered by the team at Tepnel offers two Class A isolators in a Class D room.
Using gaseous sterilisation within these isolators means that our sterility testing services are conducted in an environment free from microbial contamination. Giving you the added assurance that the testing is conducted in a completely sterile environment as preferred by Regulatory Authorities and QPs.
To discuss your project requirements contact Business Development Manager, Stewart Neithercut: [email protected] or call: +44 (0)7785 438 308
Why choose Tepnel for Sterility Testing?
- An experienced team of dedicated, trained personnel who test multiple batches on a daily basis
- Isolator technology, reducing the risk of false positives
- Gaseous sterilisation, reducing the inherent risk of contamination – giving additional confidence in the results.
“The expansion and upgrade of our sterility testing capabilities is a continuation of our commitment to our customers and the evolution of the drug development process, ensuring that our Scottish-based operations provide the best facilities for quality control testing activity. Whilst uncertainty remains around what the impact of Brexit will have on the quality control testing of pharmaceuticals in the UK, we believe that our upgrade is testament to our belief that Tepnel and Scotland remain a global leader in quality control testing and will continue to be so.” David Scott, Senior Director
Designed and installed by Bassaire Cleanrooms Limited, the new suite provides 22 square meters of testing space that meets and exceeds the requirements for grade D air quality as defined in Eudralex Vol4, GMP Annex one (incorporating EN ISO14644-1). Sterility testing at Tepnel is provided in accordance with the Harmonized method and the requirements of the EP Monograph 2.6.1 Sterility, BP Monograph Appendix XVI, A. Test for Sterility and USP Monograph <71> Sterility Tests.
