Clean Room Standards
Clean Room Standards
(OP)
Can anyone tell me why there are so many clean room standards.
Everyone knows the American Fedaeral 209 class 1, class 100, class 1000 etc. but there are many many more. i.e. GMP Good manufacturing practice etc. which seem to use variants of the federal strandard.
Do we really need more than one or two?
Any answers out there?
Everyone knows the American Fedaeral 209 class 1, class 100, class 1000 etc. but there are many many more. i.e. GMP Good manufacturing practice etc. which seem to use variants of the federal strandard.
Do we really need more than one or two?
Any answers out there?
Friar Tuck of Sherwood





RE: Clean Room Standards
TTFN
RE: Clean Room Standards
I could name probably 6 or 7 standards. All very similar.
If the Fed Std 209 has classes 1, 10, 100, 1000, 10000, 100,000,and 1000,000, how many more DO you want.
Surely we can all standardise. Life hard enough without unnecessarily complicating things.
Friar Tuck of Sherwood
RE: Clean Room Standards
Without something like Eng-Tips, 30 yrs ago; there was very little in the way of cross-pollination across industries.
TTFN
RE: Clean Room Standards
The ISO series define, broadly, particulate cleanliness classes but it is the judgement of the user as to what particle size and what condition(as built, at rest or in operatin) should he specify his cleanroom. This is where cGMP comes into picture or any other detailed standard pertaining to a different manufacturing setup.
RE: Clean Room Standards
For below Class 10,000, typically custom built complete clean room modules are specified to fit Owner's requirements (cleanliness level, cooling load, heating load, ventilation air, humidification, space temperature, lighting level). You would then engineer only the utilities required.
RE: Clean Room Standards
Friar Tuck of Sherwood
RE: Clean Room Standards
Please visit http://www.s2c2.co.uk/merchandise/ for a list of cleanroom publications.I would strongly recommend "cleanroom Design" by W White as it covers most of the industries where cleanrooms are used.It has chapters allocated to pharma,microelectronics,food and a number of other industries.It also has chapters on clean utilities for these industries.
Cleanroom design is a complex and challenging topic.All these books will only help you get started,the real experience being gained only in the field.
RE: Clean Room Standards
IMHO, cleanroom design in pharmaceutical plants is highly subjective and most of the times it is hypothetical rather than judgemental. Good Indian companies are too conservative in this but the background classification is becoming radical(particularly in Europe) with the advent of Isolator, RABS and BioSafety Cabinet technologies.
The following sites provide information with current technology and the articles are excellent.
http://www.cemag.us/
http://cr.pennnet.com/home.cfm
www.s2c2.org has one good cleanroom forum. www.ISPE.org has many forums but you can only view the threads. You should be a member if you want to participate.
Good luck,
RE: Clean Room Standards
Friar Tuck of Sherwood