How to find the best industry information and guidance?
With the explosion in the sheer volume of information now available on the internet it can be difficult to know where to find reliable answers to questions. Within the pharmaceutical and associated industries regulatory documents, such as EU GMP, provide the framework within which compliance must be sought. Interpretation and implementation of these regulations can be challenging.
International Standards Organisation (ISO) has two series of clean room standards, ISO14644 and ISO14698. Both standards have been under review for many years and whilst sections 1 and 2 of ISO14644 have been issued as draft international standards (DIS), further work on ISO14698 for bio-contamination has stopped.
Our Sales Manager, Andrew Barrow, offers an insight into monitoring cleanrooms and reducing contamination risk.
Pharmaceutical cleanrooms are classified as class 5 to class 8 according to ISO standard 14644-1 based on number of particles of specified size per m3 air. They are graded A – D by the MHRA Orange Guide (EU Guidance on GMP) based on similar particle ranges at rest and in use, with additional limits for microbial contamination in operation. The Orange Guide demands microbiological...
As a family business of over 40 years standing, Cherwell Laboratories has developed a reputation in the market based on its products and values. We hope we offer a range of high quality irradiated media products and solutions to our customers, but just as important, we strive to offer great customer service.
In today’s technology driven world it is all too easy to succumb to clever, cloud based IT solutions or converged communications and all...