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Topic Title: Periodic inspection - Pharmacy Clean Room
Topic Summary: Testing in Pharmaceuticals industry
Created On: 29 January 2013 01:20 PM
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 29 January 2013 01:20 PM
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DHourston

Posts: 8
Joined: 23 May 2007

Hi Folks,

Does anyone have any experience of carrying out fixed wire periodic inspection and test within a clean room or Aseptic Suite? We are scheduled to carry out testing is such a location for the first time. The concerns from the user are

A. The unit cannot be closed due to production pressures and potential financial loss.

B. the electrical accessories have been "Sealed" in place (silicone bead around each accessory) which when disturbed will introduce particulate contamination which will potentially result in closure of the unit.

C. Removal of light fittings affects the integrity of the suites pressure regime, again resulting in closure of the unit.

There must be hundreds of these units in the UK & Ireland so I am hoping someone in the community can give me some pointers without having to carry out a meaningless test with multiple limitations.

Many Thanks

Dave H

-------------------------
Regards

Dave H
 29 January 2013 01:39 PM
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Avatar for OMS.
OMS

Posts: 19747
Joined: 23 March 2004

I have some experience - both of testing and managing testing in aseptic environments in health care and pharma.

basically, you've answered all your own questions - don't do it when the suite is operating. Given that you also have such things as the ventilation system to clean and maintain, filters to change, isolated systems to maintain/test etc etc then electrical testing is just another task when you do the agreed shutdowns (usually all at the same time)

The timing of the shutdowns will generally dictate the testing frequencies - don't bother with partial testing etc, routine visual inspection is fine - do it once, properly - and then again when the next shut down occurs.

Given that these are often very low risk environments a frequency for (electrical) testing) of up to say 10 years would be perfectly normal - but no aspetic suite runs to controlled conditions for that time cycle. You just need to be ready to jump on it when the shutdown does occur.

regards

OMS

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Failure is always an option
 29 January 2013 03:32 PM
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DHourston

Posts: 8
Joined: 23 May 2007

Thanks OMS,

Do you revalidate the unit after maintenance or just verification?

My original question has developed into how we go about I&T and also unplanned failure/damage to accessories. The current method of installation makes it almost impossible to carry out any intrusive work/inspection for testing or accessory replacement.

Do the units you have experience with have sealed backboxes which would presumably allow for a more intrusive task without the need for revalidation?

Again, Many thanks for you input

Dave h

-------------------------
Regards

Dave H
 29 January 2013 03:55 PM
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Avatar for OMS.
OMS

Posts: 19747
Joined: 23 March 2004

Originally posted by: DHourston

Thanks OMS,

Do you revalidate the unit after maintenance or just verification?

I guess the answer to that depends on what was done to be honest.
My original question has developed into how we go about I&T and also unplanned failure/damage to accessories. The current method of installation makes it almost impossible to carry out any intrusive work/inspection for testing or accessory replacement.

almost certainly it will - once that accessory is off, the pressure regime flutters and you have exposed surfaces now "unlean" in the aseptic rom.

You almost certainly can't do anything about it except perhaps EFLI and L-N loop testing


Do the units you have experience with have sealed backboxes which would presumably allow for a more intrusive task without the need for revalidation?

Depends - modern thinking would provide sealed containment and back boxes - older design may well have more conventional back boxes and then rely on seals between the appliance and the interior surface.

surface installations with sealed containment can help as the inside of the enclosure is effectively part of the room at that point - but surface containment also presents it's own cleaning problems


Again, Many thanks for you input

No worries - it's one of those very awkward situations where you wouldn't want to do anything untill the next major refit/rekit or planned maintenance shut down - but at soime point, some one is going to damage say a socket and you have to ave an agreed plan for how you swap it out without going through significant revalidation hoops (or even re verification hoops)


Dave h


regards

OMS

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Failure is always an option
 29 January 2013 04:09 PM
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rogersmith7671

Posts: 886
Joined: 04 November 2004

I have some experience in the construction of clean room or Aseptic Suites with especially very high integrity requirements;
Quote,
A. The unit cannot be closed due to production pressures and potential financial loss.
B. the electrical accessories have been "Sealed" in place (silicone bead around each accessory) which when disturbed will introduce particulate contamination which will potentially result in closure of the unit.
C. Removal of light fittings affects the integrity of the suites pressure regime, again resulting in closure of the unit.

Under these circumstances careful examination of the design might be the best approach. it should be possible to "model" the installation and therefore "predict" cable impedance, insulation impedance and simple ohmic resistances, from the manufactures data.
These days non invasive "live" TDR can provide very accurate verification of your model.
Actual sample testing may not be possible until the replacement of any actual acsesorys if at all.
It should be possible using modern SSTDR equipment or similar to set up a constant monitoring regime that could replace a conventional "PIR" and still provide the equivalent degree of attention to possible danger.

Regards
 29 January 2013 08:03 PM
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NorthernMonkey

Posts: 7
Joined: 03 July 2007

Hi,
why not explain to the person leading the department whats involved and what you need to do to do it correctly. they can then make a decision on what level they want you to do and then organise a deep clean if required.
cheers
Ian
 30 January 2013 10:24 AM
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DHourston

Posts: 8
Joined: 23 May 2007

Thank you all for your input.

OMS - Thanks again, looks like the initial periodic is going to be painful all round as I think the best approach is to replace the existing back boxes for ones which allow replacement of accessories so revalidation, licencing etc is going to have to be factored in.

Roger - I haven't come across this type of testing. How would this be applied to a live installation (conventional power and lighting) and where can I research it?

NorthernMonkey - I have consulted with the user and we are trying to establish the extent of the potential disruption to their service over and above scheduled ahutdowns for maintenance (if any).

Again many thanks to all for their contribution.

Regards

-------------------------
Regards

Dave H
 30 January 2013 12:09 PM
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rogersmith7671

Posts: 886
Joined: 04 November 2004

Here'

">http://www.theiet.org/...s/f.....terthread=y


">http://www.utilityproduct...ity-market.html


">http://www.t3innovation.c...Utility_web.pdf


http://www.testmarshal.co.uk/


I have no connection with these company's at all, there may be other Uk firms that provide similar products. if you can find them let me know.
Regards
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