Sterility testing is required during the sterilization validation process, as well as for routine quality control and detecting major contamination in a batch.
Small molecules have traditionally been the remit of the pharmaceutical industry and have been the most important products made in this sector. Indeed, despite the recent shift towards biologics, small molecules still make up the largest majority of available treatments today. Whilst many have their basis from nature, the small molecules are very much “chemistry” based and as such have several manufacturing advantages (reduced requirements in the production process due to the ability to terminally sterilise, usually no requirement for low temperature storage) and patient administration advantages (many can be taken orally).
However, despite these advantages, it is still a requirement to work under GMP conditions (with reduced – but not eliminated - sterility control) and of course the final product batches have a requirement for sterility test to allow release and distribution.
There are several ways Bioquell can help in this market, whether it is in the set up and maintenance of clean areas by our bioquelling services or materials transfer into cleanrooms, providing equipment for more frequent elimination of bio-burden from the clean areas or in the provision of effective workstation for sterility testing to reduce the occurrence of false positives.