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Subject:
From:
SHADY ABD EL-RAOUF <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 14 Dec 2015 08:59:20 +0000
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Hi Peter,
In my opinion the real issue is in your method procedure not in the general swab low recovery itself!

I've used swabs in cleaning validation and did the recovery study for it and after some trials it gave good results (around 60-70%), but this depends on some factors you need to take care of, including:

1- Neutralizing fluid
2- Contact time of inoculum on coupons
3- Type of microorganisms used
4- Type and size of swabs used
5- Method of extraction
6- Incubation temperature

And if i read your words correctly, you said you allowed your bacterial and fungal strains to dry after inoculation, and this is just wrong! because if you inoculate vegetative cells onto stainless steel coupons and allow it to dry you will not be able to recover it
because vegetative cells suffer desiccation and, therefore, would not be viable on dry surfaces.

Only allow spore forming bacteria to dry, not all of your tested microorganisms, try to use bigger swab ending tips, after removing the inoculum with swabs, disperse it into SCDB + 1% polysorbate 80 (or the neutralizer of your choice), vortex for 30 seconds and let it stand for 20 - 30 minutes then vortex  again, plate  on SCDA and incubate for 3-5 days.

For chemical residues, a recovery greater than 80% is considered good, a recovery greater than 50% is considered
reasonable, and a recovery value less than 50% is considered questionable.

However, for bioburden, there is no set standard for an acceptable recovery from surface sampling but in general, a standard practice in the industry is to establish a minimum bioburden recovery of 50%, a value that has been found acceptable by most regulatory investigators.

Yes, maybe you will need some time to reach the appropriate recovery method but it will be worth your time as you might not be able and/or can find an appropriate method for sampling irregular surfaces except swabs, and you will be asked by investigators for the validation of your bioburden sampling method whatever it is.

You can check a book by Lucia Clontz named "Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements" Second Edition, Chapter 6: Bioburden Considerations in Equipment-Cleaning Validation for more details.

Hope this helps
Regards

Shady AbdelRaouf
Head of Microbiology
Egypt

> From: [log in to unmask]
> Subject: Re: [PMFLIST] Micro Clleaning Validation Question
> To: [log in to unmask]
> 
> Hi Peter,
>       I think you've answered your own question. You say:
> 
> How do you justify using a swab technique when performing the actual micro cleaning validation on sanitized equipment if your recovery study proved that in the lab swabbing is not an effective means for determining microorganism levels on coupons?
> 
> This is the whole point of the validation exercise, and it has failed, 
> which tells us (you) that swabs are not an appropriate methodology for 
> your stainless surfaces. In my experience, this is not surprising, and 
> many in our industry have moved away from swabs, and instead find that 
> there are other sampling technologies that are far better at recovery, 
> and are able to be validated. One such you might consider is Contact 
> Agar plates. You will need to validate them yourself, of course. Swabs 
> continue to be used in areas where the acceptance criteria are more 
> relaxed; an example might be some of the food industry applications, but 
> for high grade clean rooms, swabs that show a zero count do not 
> demonstrate compliance to the required specifications, and in the event 
> that you do observe isolates from swabs, you're probably best off 
> assuming it's an emergency! hope this helps? best regards, Aaron Fielder
> 
> 
> On 11/12/2015 6:16 AM, Peter Arena wrote:
> > My lab performed a swab recovery study for a micro cleaning validation, inoculating stainless steel coupons with various bacterial/fungal species, allowing them to dry for 15 min and then swabbing with DE Broth.  The calculated recovery rates compared to the controls were very low, in the 5-10% range.  I have read that there is no value in performing these types of recovery studies because of these low recovery rates.  My questions are as follows:  How do you justify such a low recovery rate as being acceptable?  How do you justify using a swab technique when performing the actual micro cleaning validation on sanitized equipment if your recovery study proved that in the lab swabbing is not an effective means for determining microorganism levels on coupons?  And how do I set my acceptance criteria for the cleaning swab when my recovery study has proven that I really cannot recover microorganisms from equipment surfaces?  I am not able to find any true reference for this subject.  Any advice along with citations if you have them would be appreciated.
> > Regards,
> >
> > Peter J. Arena
> > Microbiology Lab Supervisor
> > The Mentholatum Company
> > 707 Sterling Drive
> > Orchard Park, NY 14127
> > Main: 716-677-2500 ext. 1476
> > Direct: 716-558-1381
> > Fax: 716-675-2783
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> >
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> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and supported by
> our sponsors as a service to the scientific community.
> 
> Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
> 
> Veltek Associates, Inc - http://www.sterile.com
> 
> Accugen Laboratories - http://accugenlabs.com
> 
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
> 
> Analytical Research Labs - http://arlok.com/
> 
> Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics
> 
> Charles River-Endosafe and Accugenix - http://www.criver.com/emd
> 
> American Type Culture Collection - http://www.atcc.org
> 
> ATS Labs - http://www.ats-labs.com
> 
> BD Diagnostic Systems - http://www.bd.com/ds/
> 
> Biolog - http://www.biolog.com
> 
> EMD Millipore -  http://www.emdmillipore.com/biomonitoring
> 
> Microbiologics, Inc. - http://www.microbiologics.com
> 
> Microtest Laboratories, Inc. - http://www.microtestlabs.com
> 
> Nelson Labs - http://www.nelsonlabs.com
> 
> Steris - http://www.sterislifesciences.com/
> 
> 
> 
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> The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.
 		 	   		  
------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Veltek Associates, Inc - http://www.sterile.com

Accugen Laboratories - http://accugenlabs.com

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Analytical Research Labs - http://arlok.com/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

American Type Culture Collection - http://www.atcc.org

ATS Labs - http://www.ats-labs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

Microbiologics, Inc. - http://www.microbiologics.com

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Nelson Labs - http://www.nelsonlabs.com

Steris - http://www.sterislifesciences.com/



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