PMFLIST Archives

February 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Daniel Morris <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 6 Feb 2020 12:40:51 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (37 lines)
Forum,
Can you provide guidance for microbiological sample preparation and testing on  solid non-biodegradable extruded polymer passive drug delivery implants? Specifically, for pre-sterilization bioburden testing and sterility testing, is there an expectation to test just the outside surface of the implant, like one would for a medical device, or to test the "inside" of the implant since the polymer matrix elutes drug over time?
USP <1> implies that the implant may be dissolved but acknowledges that the solvents and conditions required to do this would be microbiocidal. ANSI/AAMI/ISO 11737-1 gives helpful guidance, but seems to deal only with the outside surfaces. There are a number of non-biodegradable polymer implants on the market used for contraceptive drug delivery; does anyone know how those are tested?

Thank You,
Daniel

GSK monitors email communications sent to and from GSK in order to protect GSK, our employees, customers, suppliers and business partners, from cyber threats and loss of GSK Information. GSK monitoring is conducted with appropriate confidentiality controls and in accordance with local laws and after appropriate consultation.

------------------
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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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

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

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

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

BD Industrial Media - http://www.bd.com/ds/

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

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


=================================
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.

ATOM RSS1 RSS2