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HVAC System Regulations

HVAC System Regulations

HVAC System Regulations

(OP)
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

RE: HVAC System Regulations

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

RE: HVAC System Regulations

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 This standard is about to be superseded by BS EN ISO 14644-1.

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