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November 2018

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Subject:
From:
Morgan Polen <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 26 Nov 2018 23:06:13 +0000
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Remote Particle Counting Sensors with a 1.0 CFM (28.3 LPM) flow rate is typical and I highly recommend this for continuous monitoring. Please reference Draft Annex 1 Dec 2017. Line 1667-1669 Section 9.15 (Link below) https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf


For a continuous monitoring system in pharmaceutical manufacturing  I have seen the following scenario applied and recommend this.
Sample times are 1 minute and data is reported as Particles/Ft3 on a minute by minute basis. Action and Alert limits are based upon the data collected every minute (For Both 0.5 and 5.0 micron particles). This allows operators the ability to respond to changes in airborne particle concentrations at critical locations in a timely manner (within a minute).   Additionally many of these Cleanroom Monitoring System software packages allow for the additional reporting of data in a rolling cubic meter format as well. This allows for a minute by minute response to alarms and the ability to report or trigger alarms based upon a full cubic meter of sampling.  NOTE: The initial data will not appear for the first 35 minutes as it requires a cumulation of ~35 cubic foot samples, however after the initial cubic meter is recorded, a rolling cubic meter sample volume will be updated every minute.


Additional Note, The use of these systems should be included as part of the qualification of the cleanroom during operations, especially during simulations of operations as a means of characterizing the sample location and establishing real-world action and alert limits.



Morgan Polen
Microrite, inc.
Contamination Control Consultant
www.Microrite.com<http://www.Microrite.com>
+1.408.892.1138
[log in to unmask]



On Nov 26, 2018, at 13:37, Ashley Terrell <[log in to unmask]<mailto:[log in to unmask]>> wrote:

Hello All,

If your facility is wanting to utilize a continuous particle monitoring system that measures and reports particles per 1 cubic foot each minute, how do you handle the data acquired as far as setting alert and action limits? It would take approximately 35 minutes to sample 1 cubic meter of air. The manufacturer had suggested dividing the particles per cubic meter requirement by 35.3 and set the limits that way. However, you could end up with several alert level excursions a day for the particles per cubic foot results but the particles per cubic meter counts are never exceed. Has anyone dealt with this issue before?

Kind Regards,

Ashley

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Tony Cundell
Sent: Monday, November 26, 2018 10:48 AM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: Re: [PMFLIST] Reporting particulate matter in classified areas

Using a conversion factor is problematic as the specification is set on the basis of the volume of sample collected.

On Mon, Nov 26, 2018 at 11:07 AM Adnan Zahid (Head of Quality Control) < [log in to unmask]<mailto:[log in to unmask]>> wrote:

Dear All,
Could anybody make it clear that is this possible to convert the
results of non-viable particulate matter in classified areas into m3
if sampling was done with different volume e.g. ft3. In latest ISO
14644-1 (2015) they have put examples where 1 ft3 volume was taken
however reported as m3 after multiplying it with 35.3.


Adnan

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--
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Email: [log in to unmask]<mailto:[log in to unmask]>
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