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November 2018

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Subject:
From:
James Rickloff <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 5 Nov 2018 10:42:16 -0500
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Hi Morgan,

Since the introduction of VHP generators back in the early 1990's, the term "decontamination" (not sterilization) has been applied to the technology. VHP is quite capable of sterilizing surfaces that come in direct contact with it; however, complex surfaces may provide a greater challenge to the process due to VHP's low vapor pressure under atmospheric conditions and the potential for it to gradually decompose into water vapor and oxygen. Claiming complex surfaces as being sterile would require the performance of direct spore inoculation studies, which comes with its own issues. Sterilizing BIs that are placed near complex surfaces should not be considered as an adequate test challenge. Hence, over the past 2 decades, the industry has relied upon proper equipment design to eliminate or minimize such challenges via enshrouding and/or by placing them outside of the isolator. Product contact surfaces have always been expected to be sterilized (via, steam or dry heat) prior to use. Indirect product contact surfaces such as stopper bowls have been an issue since the adoption of isolation technology. Steam sterilizing packaged bulk equipment like this is difficult enough, but then trying to aseptically reassembling them into a filling line without microbial carryover is a risk that many thought could be addressed by relying on VHP. Applications have been reviewed by the regulatory authorities and certain pre-treatment steps were recommended prior to the decontamination cycle. One step that was accepted included the application of an aqueous sterilant (6% H2O2) to complex surfaces of a stopper bowl for defined contact times. So, my recommendation would be to address such issues during the design phase, get team input early on in terms of the acceptability (or not) of design options, and then review the final design and decontamination approach with the appropriate regulatory authorities.

Oh, I take exception that VHP does not kill all species of mold. Can you provide a reference to the actual results?

Regards,

Jim Rickloff
Partner/Scientific Director
Advanced Barrier Concepts

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Morgan Polen
Sent: Sunday, November 04, 2018 1:12 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] VHP Penetration for various materials

The MHRA’s comments on why Vapour Hydrogen Peroxide (VHP) cannot be used for “sterilisation” of direct and indirect product contact parts is a very good read. VHP does not kill all species of mold, and is too fragile to be considered fro sterilization.

https://mhrainspectorate.blog.gov.uk/2018/04/20/vhp-vapour-hydrogen-peroxide-fragility/




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



On Nov 2, 2018, at 17:56, Sattelberg, Nicholas <[log in to unmask]<mailto:[log in to unmask]>> wrote:

Hi Jim,

I was just looking for a general reference for different packaging materials. We check for VHP penetration during suitability testing, but I was curious to see what materials that others have found to not be protective against VHP.

Nick Sattelberg
Lead Scientist, Microbiology


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]<mailto:[log in to unmask]>> On Behalf Of James Rickloff
Sent: Thursday, November 1, 2018 11:39 AM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: Re: [PMFLIST] VHP Penetration for various materials

CAUTION:  This email originated from outside the organization.
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Hi Nick,

I do not recall seeing a study per se, but I have personally performed these studies on a range of materials/closures over the years. Any particular question in reference to any particular ones?

Jim Rickloff
Partner/Scientific Director
Advanced Barrier Concepts

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Sattelberg, Nicholas
Sent: Thursday, November 01, 2018 7:37 AM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: [PMFLIST] VHP Penetration for various materials

Hello,

I seem to remember seeing a study referenced where VHP penetration was tested against various different materials/closures. Would anyone happen to have a link or title for this (if it exists).

Thank you,

Nick Sattelberg
Lead Scientist, Microbiology



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Sartorius https://promotions.sartorius.com/real-heroes

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Avista Pharma Solutions  http://www.avistapharma.com

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

Avista Pharma Solutions  http://www.avistapharma.com

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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