Asgard & CleanSpace's Cleanroom Specification Initiative uses best practice when considering cGMP cleanrooms or any GxP controlled environment, from project inception through detailed design, frequently considering how a correctly written cleanroom specification will impact a project design and the performance of the built asset at occupation and throughout its life cycle.
We use guidance from the following professional associations when developing design and specifications, including the following:
- ISO 14644
- EU EudraLex, Volume 4 EU GMP (Medicinal Products for Human & Veterinary Use)
- Biosafety in Microbiological and Biomedical Laboratories, 5 Edition, 2007
- 21 Code of Federal Regulations Part 210 - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs
- ASTM Standard E2500, 2007 (Standard Guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and Equipment)
- ISPE baseline guides
- EN10326-1:2016 for mechanical vibration within laboratories.
Asgard and CleanSpace also consider cost management and safety when developing client specifications as well as constructability.
It is our endeavor to assist biopharmaceutical clients and design firms to develop project specifications using the most up to date material technologies as well as disruptive and innovative technologies based on over 20 years of experience delivering cleanroom projects across Europe.
We are also delighted to be in a position to transfer this experience and knowledge base to our colleagues in CleanSpace, LLC in the US.
We strongly believe our initiative will create continuity throughout our global design community with more consistent and uniform specifications.
Ultimately, all facilities should be delivered to the same high quality standards, using globally cleanroom compliant materials and methods.
This initiative will enhance our clients’ successful operation when manufacturing life saving medicines and therapies.