Standards and Compliance

Up to date knowledge of the current cleanroom and construction standards is an operational and contractual necessity for constructing clean environments. Clean Modules stays up-to-date with current regulations and upcoming revisions to ensure our designs and installations are in line with the latest requirements, wherever we are operating.

Our comprehensive experience of rules, guides, regulations and best practices includes:

• ISO 14644-1, parts 1-5: Clean rooms and associated Controlled Environments. Classification of Air Chambers.
• EU GMP; Rules & Guidance for Pharmaceutical Manufacturers & Distributors 2007. MHRA. ISBN 978-0-85369-719-0 and amendment dated February 2008
• ATEX; ATmosphères EXplosibles directive
• Code of Practice for Tissue Banks, Department of Health (UK)
• DSEAR: Dangerous Substances and Explosive Atmospheres Regulations
• Guidance of the Microbiological Safety of Human Organs, Tissues & Cells used in transplantation, Advisory Committee on the Microbiological Safety of Blood & Tissue Transplantation MSBT The Management, Design & Operation of Microbiological Containment Laboratories, Advisory Committee on Dangerous Pathogens.

Besides the above clean environmental regulations, guidance and best practices, we also design our facilities to comply with local building control and site management regulations and can assist with planning and fire officer approvals.