The Centre for Process Innovation (CPI) has announced that the new flagship National Biologics Manufacturing Centre (part of the UK Governments Strategy for Life Science) will be located in Darlington.  Great news for strengthening the UK’s capability in biologics and developing a competitive edge within the growing global biopharmaceutical market!

Darlington was chosen based on accessibility with good transport links, proximity to existing pharmaceutical companies and universities in the region, and growth opportunities within the Tees Valley Enterprise Zone.  The new centre, which forms part of CPI, will help companies of all sizes in the biologics market to develop, prove, demonstrate, scale up and ultimately commercialise new biologics process technologies.

Read the full story here.

Thermal Compliance Ltd now distributes the 3M™ Electronic Test System (ETS) to pharmaceutical and biotechnology companies worldwide. We offer a bespoke validation package to demonstrate how the ETS system can detect air removal issues with your autoclaves to the same or better standard as your current bowie dick tests.

The system will also act as a diagnostic tool and identify potential issues with the machine in advance of cycle failure. Engineers can use the system to provide detailed traceable history of the performance of the autoclave.

Check out our webpage to find out more!

During the validation of a steam sterilisation process biological indicators (BIs) are used to demonstrate lethality within that process. BIs are distributed throughout the system/load and when the cycle has completed are removed and cultured.

The US Pharmacopeia states that biological indicators should be cultured ‘within a noted time, not more than four hours’ after the sterilisation process. 

Eric Gillitzer, Ph.D., Senior Research Scientist for Mesa Labs has written an interesting article entitled ‘Effects of Delayed Incubation on BI Resistance’ for Mesa Labs ‘Spore News’ Volume 10 No.4.