Hi Dale,
Thanks for the feedback.
Yes, I didn't think through the effect on the Acceptance Criteria when I threw in the compositing query at the end.
Given the large number of samples to be handled, am I right to presume that Direct Inoculation (depending on device size obviously) is the preferred Sterility Test method for Audit Verification testing?
LAF or Isolator discussion will presumably centre around Risk Tolerance, Turn Around Time, CAPEX and Operational Costs etc., but I'm drawn to the idea of an Isolator / Transfer Isolator set up or at least a contained system that allows a high level of confidence in consumable /package decontamination.
An active pass-thru system with combined decontamination might also warrant consideration, does anyone have any experience of same?
Any further insights would be most welcome, as I am interested in getting an idea of the options or various approaches currently used by contributors with respect to high volume through-put (100 samples) for Sterility testing.
Best Regards
Derek
Dr. Derek Freeman
Principal DFMicro
Microbiology & QA Consultants
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Kelley, Dale <[log in to unmask]>
Sent: 03 May 2023 19:08
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] Corrected Version: Sterility Testing - ISO11137 Method 1 Dose Verification
Derek,
It is not uncommon for dose audit sterility testing to be performed in a LAF with appropriate controls in place (see A.6.3 or ISO 11737 Part 2). That said, if you are using isolators for testing, you would just need to ensure that your documentation and process take into account the extended period it will take to perform the testing.
You should never composite the tests, it would confound the interpretation step, which depends on 100 individual results.
Regards,
Dale Kelley, CQA (he/him)
QA Auditor Sr
Quality
Medline Industries, LP
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-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of D Free
Sent: Wednesday, May 3, 2023 11:02 AM
To: [log in to unmask]
Subject: [PMFLIST] Corrected Version: Sterility Testing - ISO11137 Method 1 Dose Verification
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.
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Apologies to all for the formatting etc on previous version - I appear to have Outlook issues (that's my excuse anyway and I'm sticking with it) Hope this is better. DF
Hi All,
A quick test strategy query for those of you familiar with sterility testing of radiation sterilised product using ISO 11137 - Part 2, Dose Verification according to Method 1.
While familiar with sterility testing of drug product and water where comparatively small sample numbers for lot related test, I would like to avail of members experience and expert feedback in relation to Dose Verification testing of sterilised devices where testing of 100 samples is prescribed.
What is or would be your preferred or standard approach for such a high number of samples,
1: A test campaign over several shifts or several days? (obviously with added contamination risk potential),
2: Multiple Isolators? (e.g. at 2 Isolator units)
3: Use of additional Transfer Isolator Units to allow semi-continuous operation / test turn around?
4: A mix of the above?
5: A Customised Isolator Design?
Also, I would like to know if compositing of devices for Dose Verification testing is permitted or is it dependent purely on ease of handling, logistics, or ergonomic constraints?
Any and all feedback much appreciated, thanking you in advance,
Best Regards
Derek
Dr. Derek Freeman
Principal DFMicro
Microbiology & QA Consultants
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