Comments on: Ask The Experts

By: Lutfi Asyairi

Lutfi Asyairi — Wed, 19 Sep 2007 06:36:51 +0000

Hi, i work in Pharmaceutical clean room.
i want to ask some question:
On ISO standard room classification was based on standard eror which calculate from discrate particle counter, how we classified the clean room if we used continous particle counter ?? do we need to calculate sampling location and the standard error??

Thanks in advance

By: Rod

Rod — Thu, 01 Mar 2007 13:59:24 +0000

Muna,

A Class A Clean room is equal to an ISO 5 or Class 100 (Fed. Std. 209e) clean room here in the US.

A Solair 3100 / 3100+ would be the best fit, but if funding is not available, you can get by with a 3016 for verification purposes - The GMP standard requires that 1.0 CFM of air be sampled.

The Solair 3100 or 3100+ is a 1.0 CFM (28.3 LPM) portable particle counter:

The 3016 is a 0.1 CFM (2.83 LPM) handheld particle counter:

By: Muna Kamel

Muna Kamel — Thu, 01 Mar 2007 13:56:55 +0000

What would be the best particle counters for clean room class A and C rooms which would meet the GMP requirements.

By: Jp Leblanc

Jp Leblanc — Sat, 16 Sep 2006 18:00:26 +0000

Hi. I am a Quality Auditor at a truck manufacturing plant in Ontario, Canada. I am currently taking particle readings in the paint system, and in the booths themselves. There is a Prime line system, the topcoat system,and the plastic line. I am having trouble finding out what the limit levels would be in a clean air system. I know that readings inside the tack, spray, and flash booths should be “0″, but what limits are there within the clean room> I am currently taking readings at 5 microns. Any help would be appreciated.

By: Jack

Jack — Sat, 25 Mar 2006 22:59:06 +0000

Rod and Jim,
Thanks very much for your help and information!