HVAC System Regulations

[pritel]

Could anybody help with the web address for the the HVAC regs that apply to clean rooms/Labs within the medical industry in the United Kingdom.

Regards

Dave Hargreaves

 

[johninsligo]

Dave

I'm not sure about web addresses but I am doing a similar job myself and wish to do a code compliance check.

So far the regulations I can point you towards are:-

- European Annex to GMP '97
- BS5295 Part 1:1976 environmental cleanliness in enclosed spaces - definition of air quality categories
- the quality assurance of aseptic preparation services, NHS
- rules and guidance for pharmaceutical manufacturers and distributors 1997 MCA

- HEPA filter efficiency to 99.97% at 0.3 microns typically for grade D or class 100,000 clean room. (US Federal Standard 209E)

US standards are available on line to download and BS's probably are.

Hope this is some help

Regards

John in Sligo

 

[hosec]

In the UK the British Standard 5295, published in 1989, is also used to classify cleanrooms. This standard is about to be superseded by BS EN ISO 14644-1.

 

Check out

http://www.bocai.org/