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May 2020

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Subject:
From:
Frank Settineri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 15 May 2020 00:22:29 +0000
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Agreed wholeheartedly. 
Sincerely,

Frank Settineri 
Veracorp LLC 
Sparta, New Jersey 
908-499-5540 
www.veracorp.biz 
http://www.linkedin.com/in/veracorp

Strengthening Businesses, Strengthening Lives

 

    On Thursday, May 14, 2020, 06:36:29 PM EDT, Donald English <[log in to unmask]> wrote:  
 
 Dear Samir,

I do not understand as to why you are saying that a single use product will require a preservative and a preservative will ensure that the microbial counts will remain the same during shelf-life.  If you are doing this , I think that you have bigger issues in your manufacturing facility than just including a preservative in a single use product application.

From my prespective, you only add preservatives to multiple dose product formulations in order to prevent the proliferation of organisms that are introduced during consumer usage and not during manufacturing.  With a single use product, you may have the introduction of organisms during consumer usage, but they will not proliferate because you no longer have any product left to use after the single application.  I can see having a preservative in a single use product if that formulation is also going to be used in a multiple dose product package as a different SKU.

Your justification for including  a preservative in a product formulation to prevent the proliferation of organisms during the product shelf-life is a little hard for me to understand.  In general, the only way in which organisms could proliferate in a product formulation is that it contains a raw ingredient that could serve as a microbial nutrient.  In general, the majority of raw ingredients in a non-sterile product formulation are not able to serve as a microbial nutrient.  If you had one, there are a lot of other factors that are involved for a organism to proliferate in a formulation after manufacturing such as pH and the presence of oxygen.  From conducting development work, I would think that you would see this before the product ever goes into production.

Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

Sent from my iPhone

> On May 14, 2020, at 3:45 PM, Shah, Samir <[log in to unmask]> wrote:
> 
> 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
>> C0%7C637250584054541027&amp;sdata=aQ0iLmJNv1txJoXvdjE%2F5SThQ7OVWjBDBz
>> e1pm4k%2F%2F4%3D&amp;reserved=0
>> 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
>> bK%2BeggGYKymJCsuxVj3bonlHA6L5L0%3D&amp;reserved=0
>> Veltek Associates, Inc -
>> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
>> terile.com%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff42
>> 0eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250
>> 584054551019&amp;sdata=SSNAe%2F1Tx014BXnmRiPU1%2FjHyhuwnheYZVNJjTNDB3M
>> %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
>> C637250584054551019&amp;sdata=ph0MfLTckpnWOlwvahYGIIKrL8qa0y8JVXPM4KvO
>> TxE%3D&amp;reserved=0
>> BD Industrial Media -
>> https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.b
>> d.com%2Fds%2F&amp;data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff42
>> 0eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250
>> 584054551019&amp;sdata=4r30l%2B13H90jtmCxoh90SQJPK7Xe%2FzvrKYOlGQfG%2B
>> 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
>> =================================
>> The nature of this service is to provide a medium for communication.
>> The specific statements and endorsements of individuals participating
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>> sponsors of the list.
> 
> 
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
> 
> ------------------
> The PMFList is supported by our sponsors as a service to the scientific community.
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> 
> 
> Steris - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterislifesciences.com%2F&data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&sdata=8rjg%2F1IUY3qAQn1vEK7H1r9m%2FfuGUap4fAWi54%2BM9OA%3D&reserved=0
> 
> Charles River Laboratories - https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&sdata=B9zZIVdPDoMN%2FbK%2BeggGYKymJCsuxVj3bonlHA6L5L0%3D&reserved=0
> 
> Veltek Associates, Inc - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterile.com%2F&data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&sdata=SSNAe%2F1Tx014BXnmRiPU1%2FjHyhuwnheYZVNJjTNDB3M%3D&reserved=0
> 
> Microbiologics, Inc. - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.microbiologics.com%2F&data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&sdata=ph0MfLTckpnWOlwvahYGIIKrL8qa0y8JVXPM4KvOTxE%3D&reserved=0
> 
> BD Industrial Media - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bd.com%2Fds%2F&data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&sdata=4r30l%2B13H90jtmCxoh90SQJPK7Xe%2FzvrKYOlGQfG%2BZI%3D&reserved=0
> 
> Associates of Cape Cod, Inc. - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&data=02%7C01%7Csamir.shah%40BMS.COM%7C5539fe8c8fff420eb72b08d7f807a5f9%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637250584054551019&sdata=tn8Tj5DAW1%2BzRCYQcdODttX7%2BE0sJKlNw7a8RV7xq0I%3D&reserved=0
> 
> 
> =================================
> 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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> ------------------
> The PMFList is supported by our sponsors as a service to the scientific community.
> 
> Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
> If your company would be interested in sponsoring this community, please contact [log in to unmask]
> 
> 
> 
> 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.

------------------
The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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.
  

------------------
The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



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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