Thanks Tony,
Yes, you are correct, routine release testing is parametric in nature, based on established bioburden characteristics and / or dosimetric considerations.
The question specifically relates to Dose Audit Verification.
My understanding, was that alongside parametric product release based on a validated process, (Method 1, 2 or VDmax),
Periodic Dose Verification Audits (e.g., usually quarterly or sometimes more frequently based on characteristic bioburden levels) are carried out for both for Bioburden & Sterility, 10 for each test respectively if using the VDmax approach for dose calculation, and 10 & 100 samples respectively, when using Method 1 or Method 2.
I'm not overly familiar with ISO based, Sterility Test Protocols Radiated Product, so I will double check the standard.
Thanks & 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 D Free <[log in to unmask]>
Sent: 03 May 2023 18:01
To: [log in to unmask] <[log in to unmask]>
Subject: [PMFLIST] Corrected Version: Sterility Testing - ISO11137 Method 1 Dose Verification
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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