The Class D cleanroom provides sterility testing in accordance with the Harmonised method and the requirements of the EP Monograph.
Tepnel Pharma Services has received validation for its new Class D cleanroom environment. The room will be used for sterility testing of various developmental and market authorised pharmaceutical products.
Dave Scott, Senior, Director of Tepnel Pharma Services, said:
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. It ensures our Scottish-based operations provide the best facilities for quality control testing activity.
The upgrades were completed with no impact on customer service and are testament to our belief that Tepnel and Scotland will continue to be a global leader in quality control.
The new laboratories at the CRO were designed and installed by Bassaire Cleanrooms Limited. The rooms allow Tepnel Pharma Services to provide quality control testing and support services solely focused on supporting the pharmaceutical industry.
Offering both microbiology and chemical analysis under one roof, Tepnel offers quality control testing that includes:
- Batch Release Services – Supporting release testing of parenteral, oral, inhalation and other formulation types for the UK, European and rest of world markets.
- ICH Stability Testing – Available conditions and storage solutions are suitable for long term, intermediate, accelerated, photo-stability, in-use, FUST stability trials and Accelerated Stability Assessment Program (ASAP) for rapid stability assessments.
- Raw Materials Testing – Comprehensive services using pharmacopoeial methods for testing of pharmaceutical excipients and ingredients to meet a wide range of purposes, such as prequalification, acceptance of consignments, conformance testing and in-process control.
- Method Development and Validation – Supporting the development and validation of procedures across a range of detection technologies to support development and manufacture of pharmaceuticals.
Designed and installed by Bassaire Cleanrooms Limited, the new suite provides 22 sqm of testing space that meets and exceeds the requirements for grade D air quality as defined in Eudralex Vol 4, GMP Annex one (incorporating EN ISO14644-1).
Sterility testing at Tepnel Pharma Services is provided in accordance with the Harmonised 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.
Tepnel Pharma Services, which has been providing pharmaceutical microbiology service for over 30 years, is located in the heartlands of Scotland’s Life Sciences community.