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May 2020

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Subject:
From:
"Shah, Samir" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 14 May 2020 14:39:32 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (148 lines)
A single use product will need preservative since it is non-sterile. Challenge test can be performed at time 0 but not required over stability. Time 0 PET/AET will ensure that if you start with microbial counts less than specification, they will not grow over the shelf life. Microbial limits test at the time of release will ensure you have absence of objectionables and counts are less that the established specification. Presence of effective preservative will ensure the counts will not grow over shefl-life.

If you want to avoid putting preservative altogether, individual single use blow fill vials is an option (e.g., single use, preservative free eye drops)

-Samir


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Tony Cundell
Sent: Thursday, May 14, 2020 8:38 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] PET test

[Use CAUTION when opening links/attachments]

Adding a preservative system to a single-use nasal spray would need to be justified to the FDA and when justified pass the USP <51> Antimicrobial Effectiveness Test.

Do you share the same formulation with a multiple use products? Is that the reason?

On Thu, May 14, 2020 at 1:27 AM Michael Barton <[log in to unmask]>
wrote:

> Hi All,
> if we have a single use non-sterile nasal spray that is preserved,
> does it require PET to be performed or is this only needed for multi
> dose product as this can be contaminated by patient during routine use?
>
> Thanks Mike
>
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> Steris -
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
> terislifesciences.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C553
> 9fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7
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> e1pm4k%2F%2F4%3D&amp;reserved=0
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> Charles River Laboratories -
> https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2
> .criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7Csamir
> .shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a
> 2594acadab6e4ac%7C0%7C0%7C637250584054551019&amp;sdata=B9zZIVdPDoMN%2F
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> terile.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff42
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> %3D&amp;reserved=0
>
> Microbiologics, Inc. -
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.m
> icrobiologics.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8
> c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7
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> BD Industrial Media -
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> ZI%3D&amp;reserved=0
>
> Associates of Cape Cod, Inc. -
> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.a
> cciusa.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff42
> 0eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250
> 584054551019&amp;sdata=tn8Tj5DAW1%2BzRCYQcdODttX7%2BE0sJKlNw7a8RV7xq0I
> %3D&amp;reserved=0
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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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Veltek Associates, Inc - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterile.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&amp;sdata=SSNAe%2F1Tx014BXnmRiPU1%2FjHyhuwnheYZVNJjTNDB3M%3D&amp;reserved=0

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BD Industrial Media - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bd.com%2Fds%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&amp;sdata=4r30l%2B13H90jtmCxoh90SQJPK7Xe%2FzvrKYOlGQfG%2BZI%3D&amp;reserved=0

Associates of Cape Cod, Inc. - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&amp;sdata=tn8Tj5DAW1%2BzRCYQcdODttX7%2BE0sJKlNw7a8RV7xq0I%3D&amp;reserved=0


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

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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

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

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

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 PMF or the sponsors of the list.

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