Jay,

The auditors' advice is an overkill. Do a risk assessment and limit your
disinfectant evaluation to the most critical cleanroom materials.

The disinfectant vendors should assist more and companies publish their
findings so we can avoid repeating these studies.

The USP microbiology expert committee did revise <1071> to make the process
less demanding but the in-process version was not published.

Tony

Tony

On Sat, Feb 25, 2023 at 11:16 AM jay patel <
[log in to unmask]> wrote:

> Dear, We are also looking for some rationale or risk assessment for
> different clean room surfaces. We had performed DET study on representative
> surfaces of clean room I.e, Stainless steel, Glass, PVC, gloves, Tyvek
> sheet, PVDF, MS powder coated materials, Glavanized door panel, Epoxy,
> Aluminum door, delrin, Stone etc. More than 15 surfaces We had covered in
> DET study. Auditor suggest that you have to perform DET study on all clean
> room surfaces. After GEMBA, we have identified more than 30 different
> surfaces used in clean room .Is it necessary to perform DET study on all
> surfaces?Please provide some guidance or rational for above situations
> Regards,Jaymit Patel
>
> Sent from Yahoo Mail on Android
>
>   On Sat, 25 Feb 2023 at 5:09 am, [log in to unmask]<
> [log in to unmask]> wrote:   Hi Team,
>
>
>
> Has anyone had, or know of anyone who has had, success in leveraging a DE
> study performed by the vendor using standard coupons rather than repeating
> the same work on the same materials against the same disinfectant?  I've
> heard talk of the FDA considering this, but I wasn't sure if anyone has
> tried it yet.
>
>
>
> Thank you!
>
>
>
>
>
>
>
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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Current Sponsors:

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

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

Novatek International https://ntint.com/

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

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



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