Comments on: ISO 14644 Cleanroom Validating to ISO Class 8

By: tricon

tricon — Mon, 30 Mar 2009 14:38:21 +0000

Hi,
I am looking to scource information on ISO 14644 class 8 standards with particular emphasis on how this standard impacts on a machine builder. Is there a particular website or literature that may be of use to me. One of the criteria required for the machine is that it will be installed in – “Operating environment: ISO 14644 Class 8″

Thank’s

By: qin

qin — Tue, 20 Jan 2009 06:00:12 +0000

Hi,
May I know how to calculate the CFU per cubic meter from the number of colony units formed on the agar plate?

Thanks.

By: formula for air exchanges per hour

formula for air exchanges per hour — Thu, 12 Jun 2008 04:21:14 +0000

[...] the formula is very simple. … cubic feet per minute required for one complete air exchange. …http://www.particlecounters.org/blog/iso-14644-cleanroom-validating-to-iso-class-8/Cornwall Kitchen Bathroom Flooring Interiors and Garden. Miller …… a formula as a starting point [...]

By: gbelezos

gbelezos — Mon, 19 May 2008 20:20:30 +0000

Hello. I have been tasked to re-implement air particle checks in our class 1, class 10, and class 10000 cleanrooms. I have climet 400 particle counter which seems to work well. What would you recommend for monitoring the fab, in terms of settings (1 or .1 cubic feet, .3 or .5 um, #readings at each point) and frequency. I am new to this and have no guidance at my small company. Thanks.

By: Dan Milholland

Dan Milholland — Mon, 14 Apr 2008 16:01:11 +0000

Jigendra ,

Class D Air is defined in Volume 4, EU Guidelines to GMP, Annex 1. Section 19 “Recommended limits for microbiological monitoring of clean spaces during operation” states Class D should average no more than 200 cfu/cubic meter if using an air sampler and 100 cfu/4 hours on 90 mm diameter settling plates.” If the sample rate of your air sampler is 100 lpm, then you would have sampled 1,000 l or 1 cu meter in 10 minutes. That should meet or exceed the regulatory requirements.