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November 2018

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Subject:
From:
Hank Rahe <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 29 Nov 2018 16:42:03 +0000
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Hello Hello
There is an article titled “Permeation of Gaseous Hydrogen Peroxide and Peracetic Acid into IV bags during their surface sterilization” Hospital Pharmacy February 2002.  This article tested various material of construction of IV bags.

CTG had some testing conducted and used a lab that analyzed IV bags made of various materials.  We placed the IV bags into a MIC chamber and did a six log kill cycle then removed the bags at different times to get an idea of permeability of the different bag materials.
The lab used a Xylenol Orange Spectrophotometric assay.  PVC IV bags showed the greatest permeation.
 
Hank

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Jim Rickloff
Sent: Thursday, November 29, 2018 8:17 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] VHP concentration testing in liquid

Well, that is opening a can of worms Nick. Spore germination can be inhibited with around 100 ppm in recovery media. To avoid the “worms”, our preference is to observe no detectable H2O2 concentration inside containers. If there is some, we begin looking at abbreviated Decon cycles. 

I have not seen any MIC studies performed using H2O2. This chemical has been used in water disinfection, so low ppm levels may be capable of inactivating some microorganisms. Hence, it is better to show that it is not present for Sterility Test applications.

FYI - The MQuant test strips are very sensitive, so rinse all external container surfaces and your gloved hands with tap water prior to assay. 

Regards,

Jim Rickloff
Partner/Scientific Director
Advanced Barrier Concepts, Inc.
919-868-9561
Sent from my iPhone

> On Nov 28, 2018, at 3:32 PM, Sattelberg, Nicholas <[log in to unmask]> wrote:
> 
> Hi Jim,
> 
> Thank you for the response.
> 
> Somewhat related, has anyone come across any literature showing when peroxide concentration starts to affect organism growth? I know this is probably too general but I wouldn't imagine something like 5 ppm showing much inhibition.
> 
> Nick Sattelberg
> Lead Scientist, Microbiology
>    
> 
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List 
> <[log in to unmask]> On Behalf Of James Rickloff
> Sent: Wednesday, November 28, 2018 1:09 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] VHP concentration testing in liquid
> 
> CAUTION:  This email originated from outside the organization.
> Do not click or open attachments unless you recognize the sender.
> 
> 
> Hi Nick,
> 
> I have used EMD Millipore MQuant H2O2 test strips over the years for a semi-quantitative (0.5-25 ppm) assay of WFI in a variety of containers.
> There are a variety of quantitative assays available that can accurately detect concentrations in the ppb range. The VHP Validation Manual from STERIS describes a Xylenol Orange Spectrophotometric assay that is accurate down to the 100 ppb range.
> 
> Regards,
> 
> Jim Rickloff
> Advanced Barrier Concepts
> 
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List 
> [mailto:[log in to unmask]] On Behalf Of 
> Sattelberg, Nicholas
> Sent: Wednesday, November 28, 2018 8:39 AM
> To: [log in to unmask]
> Subject: [PMFLIST] VHP concentration testing in liquid
> 
> Hello,
> 
> I was curious what others are using to test VHP concentration in liquids when performing VHP penetration testing. We are currently using test strips from Water Works, though I am not sure how accurate these are. I could also foresee issues with dark colored liquids as well since you are using a color change scale similar to pH test strips.
> 
> Thank you,
> 
> Nick Sattelberg
> Lead Scientist, Microbiology
> 
> 
> 
> Catalent Pharma Solutions e-mail is for the designated recipient only and may contain privileged, proprietary, or otherwise private information. If you have received an e-mail in error, please notify the Catalent sender immediately and delete the original. Any other use of the e-mail by you is prohibited.
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

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

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

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

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

Boston Analytical http://www.bostonanalytical.com/

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


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

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