PMFLIST Archives

June 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Sattelberg, Nicholas" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 25 Jun 2020 17:40:05 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (179 lines)
Thanks for the response Don. I am going to try exactly as you mentioned and buy a few of the tap kits from Home Depot and get some tubing that will fit. I figured it would be pretty easy to autoclave these in a steam sterilization pouch to take into a hood for testing.

Nick Sattelberg
Group Leader, Microbiology


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Donald English
Sent: Wednesday, June 24, 2020 6:28 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Sampling device for metered dose inhalation canisters

CAUTION:  This email originated from outside the organization.
Do not click or open attachments unless you recognize the sender.

Dear Nicholas,



From my experience, I have always used the chilling method for sampling pressurized aerosol inhalation products in which the outside of the containers was disinfected first with sterile 60-70% alcohol and allowed to dry.  After the outside of the aerosol containers were dried, they were placed into a dry ice bath or a low temperature freezer for freezing before the containers were punctured for conducting microbial sampling.



I always wonder about the ice maker water tap line that is present in USP Chapter 610.  I think that the device that you are looking for from USP Chapter 610 is an actual ice maker water tap line connector that is used normally to connect a refrigerator ice maker to a copper water line within the house.  By connecting a sterile plastic hose to the end of the ice maker water tap line connector that is used to deliver water to a refrigerator ice maker, you can control the flow of the contents of an aerosol container into a diluent or broth by puncturing a hole into the pressurized aerosol container by using the needle of an ice maker water tap connector and withdrawing the needle to control the flow out of the  punctured container.  These ice maker water tap line connectors are readily available at a hardware store.



I will admit that I have never seen a commercial sampling device with a needle for puncturing pressurized aerosol inhalation containers since I believe that the marketplace for such a sampling device would be exceedingly small.



Don



Donald J. English Microbiological Quality Consulting LLC

Florham Park, New Jersey 07932

On Wed, Jun 24, 2020 at 8:31 AM Sattelberg, Nicholas < [log in to unmask]> wrote:

> Hello,
>
> USP <610> describes alternate sampling methods for inhalation and
> nasal products; under the "room temperature method" for high-content
> INDP it mentions using a ice maker water tap line or other type of
> needle apparatus to puncture the canister and expel the contents
> through a line, either into a vessel or directly into the broth/buffer media.
>
> I was curious if anyone knows of any devices available for this
> specific purpose? We have automatic can cutters but that is an
> enclosed unit that cuts the entire top of the canister off, so that
> wouldn't work in this application. I'm looking for something that will
> allow controlled release of the MDI contents into a vessel.
>
> Thank you,
>
> Nick Sattelberg
> Group Leader, Microbiology
>
>
>
> Catalent Pharma Solutions e-mail is for the designated recipient only
> and may contain privileged, proprietary, or otherwise private
> information. If you have received an e-mail in error, please notify
> the Catalent sender immediately and delete the original. Any other use
> of the e-mail by you is prohibited.
>
> ------------------
> 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 -
> https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
> terislifesciences.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATA
> LENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076
> 949bbc8d%7C0%7C0%7C637287005582224958&amp;sdata=n9G%2BNsbUNDdyp5cgkNFH
> p4bci89y0YQiFJP5XbB1mdg%3D&amp;reserved=0
>
> Charles River Laboratories -
> https://eur02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2
> .criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7CNicho
> las.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2b
> c6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582224958&amp;sdata=C
> 1QFEDQsz5v1fqO3Y6SkZTGIgxq4mN%2B5WAro06VMJRQ%3D&amp;reserved=0
>
> Veltek Associates, Inc -
> https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.s
> terile.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7C
> d51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C
> 0%7C0%7C637287005582224958&amp;sdata=V2vn8OJusX%2FUrGNy5P1CyBJW01Zw0hS
> MJqJ40KP%2FDCs%3D&amp;reserved=0
>
> Microbiologics, Inc. -
> https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.m
> icrobiologics.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT
> .COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949b
> bc8d%7C0%7C0%7C637287005582224958&amp;sdata=EJk3cXEnIFl4j3Q66KFd2w4vQe
> Pt45EngPEutaUWo8s%3D&amp;reserved=0
>
> BD Industrial Media -
> https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.b
> d.com%2Fds%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7C
> d51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C
> 0%7C0%7C637287005582224958&amp;sdata=OLL%2BJDVrCkJZPxbY99HKBRsODOXBSBw
> LOtiOaaDHPYM%3D&amp;reserved=0
>
> Associates of Cape Cod, Inc. -
> https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.a
> cciusa.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7C
> d51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C
> 0%7C0%7C637287005582234951&amp;sdata=2HZkRLJ7XdhQLacs3vShtCIoE005gTutJ
> 7Gy%2Fx4PVKc%3D&amp;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.
>

------------------
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 - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterislifesciences.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582234951&amp;sdata=AnL5EX6T81UdSEjuxfFJ3QtysAKAlTXR2Bk7NMzihQ8%3D&amp;reserved=0

Charles River Laboratories - https://eur02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww2.criver.com%2Fl%2F60962%2F2020-03-27%2Fh6jqv6&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582234951&amp;sdata=Aes6mbSgS8fE1z1KQo8izfGrHrcCHulqCABswXjZHdI%3D&amp;reserved=0

Veltek Associates, Inc - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.sterile.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582234951&amp;sdata=wJBUegVPv46Dz2vNeDifU2y7fUcfnCd6vEU20CU1eTs%3D&amp;reserved=0

Microbiologics, Inc. - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.microbiologics.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582234951&amp;sdata=WFcaxBocKeXWlEAj6TK8c8quFVRXBBpMq0tB9R7g%2FSw%3D&amp;reserved=0

BD Industrial Media - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bd.com%2Fds%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582234951&amp;sdata=H%2Fqa5iiAa65cd0%2FwKMbEAOTJJFCSM%2FDAljBwnJK7ETA%3D&amp;reserved=0

Associates of Cape Cod, Inc. - https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&amp;data=02%7C01%7CNicholas.sattelberg%40CATALENT.COM%7Cd51102198e9048979c9b08d81927b311%7Cc2bc6cae7bbb4cda9ebc2076949bbc8d%7C0%7C0%7C637287005582234951&amp;sdata=2HZkRLJ7XdhQLacs3vShtCIoE005gTutJ7Gy%2Fx4PVKc%3D&amp;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.

Catalent Pharma Solutions e-mail is for the designated recipient only and may contain privileged, proprietary, or otherwise private information. If you have received an e-mail in error, please notify the Catalent sender immediately and delete the original. Any other use of the e-mail by you is prohibited.

------------------
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.

ATOM RSS1 RSS2