New Harmonised Microbiology Methods
Tepnel Pharmaceutical Services is now able to offer the harmonised methods for non-sterile microbiological testing, making it quicker, more cost effective and easier for manufacturers to comply with the new regulations for European, US and Japanese Pharmacopoeias.
Tepnel Pharmaceutical Services is an established business of Gen-Probe Incorporated, a world leader in molecular diagnostics.
The new methodology consolidates the existing methods whilst revising the media types and qualification requirements thereby reducing the quantity of sample required for some testing. The harmonised method for specified micro-organisms also includes a new specific test organism (Candida albicans) and allows for variable sample quantity and changed limits depending on factors such as batch size and intended use.
In addition, the harmonised approach improves microbiological testing by changing to more modern media formulations. These improvements help to drive efficiency by reducing the requirement for duplicate testing which can streamline raw material, active ingredient or finished product release.
Tepnel Pharmaceutical Services has completed the method establishment for both parts of the Microbiological Examination of Non-Sterile Products tests, namely the Microbial Enumeration Tests and the Test for Specified Micro-Organisms. This methodology has been developed in line with the guidance from the commissioners of the British, European, United States, and Japanese Pharmacopoeias which provide a single harmonized testing method.
Tepnel strengthens its pharmaceutical services team
Tepnel Research Products & Services has strengthened its pharmaceutical services team based in Livingston, Scotland with three key new appointments. Dr William Herron joins as Laboratory Manager for Bioanalytical Services, Dr Emma Waite as Laboratory Manager for Biopharmaceutical Services, and Mr Chris Miller steps up to the role of Business Development Manager.
(Read More)
