Clean Room Standards

[friartuck]

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?



Friar Tuck of Sherwood

 

[IRstuff]

Different industries, different standards.

TTFN

 

[friartuck]

But why re-invent the wheel. If it ain't broke, don't fix it.

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

 

[IRstuff]

But, it isn't a question of re-inventing, but simultaneous invention.

Without something like Eng-Tips, 30 yrs ago; there was very little in the way of cross-pollination across industries.


TTFN

 

[quark]

As IRStuff rightly said, no single standard can be able to specify codes to entire gamut of operations of all types of industry. This may be required for some types of industries but absolutely redundant for other types. For ex. neither FED Std 209E(which is obsolete now) or ISO14644 series are silent on microbial and pressure balancing issues which are very critical to pharma.

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.

 

[lilliput1]

Cleanliness levels are require to protect the product or safeguard the process so the product may pass quality inspection with minimal rejected products. The advent of electronic microcircuits has further increased the demands on cleanliness.
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.

 

[friartuck]

Can anyone recommend a good clean room design book-which includes pharmacy and electronics industries



Friar Tuck of Sherwood

 

[SAK9]

Friartuck,

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.

 

[quark]

Cleanroom Design and Cleanroom Technology by W.Whyte are two good books but they are pretty expensive(about 90USD each)

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

http://www.s2c2.org

has one good cleanroom forum.

http://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,

 

[friartuck]

Thanks everyone

Friar Tuck of Sherwood