Project: Microbiological Safety Cabinet & HVAC Systems

Location: Kent. UK

Engineering Design & HVAC Consultants

During survey’s by The GMP Group to check the cGMP compliance of the MSC’s (over 600 on site) and HVAC systems,(100 plus systems) it was determined that many of the MSC and HVAC systems where failing the basic safety tests. The GMP Group are now employed by the client to head up a project to determine MSC and HVAC strategy for the whole site together with the detailed engineering and on going qualification, testing and cGMP compliance. The GMP Group is also advising the client on maintenance regimes and requirements to ensure the on going compliance of the HVAC and Safety Cabinets.

The client’s wish was 2 fold :

• To ensure that the site complied with current ISO standards for the location and use of the MSC and that the HVAC systems did not adversely effect the operation of the MSC’s.
• To bring this site into the GMP/GLP/GCP compliance regimes, The GMP Group are working with the client to introduce systems for change control in all areas of the site.