Based on the stated sterile label claim, generally the entire device is
transferred to media unless detailed otherwise (e.g., sterile fluid
pathway).  As for the sample size, a 100-sample transfer is basically the
industry norm for Method 1/2 dose auditing.  E.g., if performing a
full/complete Method 2 validation, the sample size would be nominally 640
samples.   As with any transfer methodology, the expected false positive
rate is a limit approaching zero, but a limit nonetheless (i.e.,
non-zero).  Based on the transfer complexity, transfer in a LAF may be more
than sufficient.  Naturally, an isolator would provide another layer of
potential contamination mitigation.

On Fri, May 5, 2023 at 9:09 AM D Free <[log in to unmask]> wrote:

> 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
>
> https://emea01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.medline.com%2F&data=05%7C01%7C%7Cb3772bd46f7a425d227808db4c22c55f%7C84df9e7fe9f640afb435aaaaaaaaaaaa%7C1%7C0%7C638187484493237159%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=78gLSbsl2L7tlOD9n1%2FQIlttmzZtPmUcI1wA4lI2uMU%3D&reserved=0
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> [log in to unmask]
>
>
>
> -----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.
>
> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
> 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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