PMFLIST Archives

April 2017

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:
Shiva Prasad <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 6 Apr 2017 00:53:01 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (170 lines)
Dear forum,
We have a steam sterilizer in microbiology laboratory and it's IQ and OQ
completed.PQ is is not yet started.My question is can we the same for
sterilization of some media for the initiation of laboratory activities
because our  New facility. We can go through the proper QMS system for
usage of steam sterilizer?
Pls suggest your valuable information.

Regards,
Shivaprasad
Aurobindo pharma
Hyderabad,India

On Thu 6 Apr, 2017 3:47 am Dale Kelley, <[log in to unmask]> wrote:

> Justin,
> It depends entirely on what you are planning to build.  But with TS added
> to the equation, the minimum I would expect to see is ISO 8.  Some device
> classes require ISO 7 or higher (implantable, IV fluid path, etc.).
> You will need to determine the finished device requirements and work
> backwards from there.
>
>
> Dale Kelley
> Director
> Protocol Link, Inc.
> 175 E. Hawthorn Parkway, Suite 210
> Vernon Hills, IL 60061 USA
> cell +1-224-565-2790 || office +1-847-549-0390
> www.protocollink.com
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List [mailto:
> [log in to unmask]] On Behalf Of Justin Tettenborn
> Sent: Monday, April 03, 2017 3:10 PM
> To: [log in to unmask]
> Subject: [PMFLIST] ISO class 9 environment requirements
>
> Good afternoon,
> My company currently produces non-sterile medical devices in a large
> warehouse style manufacturing floor. The manufacturing area is only
> delineated by a line of tape to keep it from the shipping and receiving
> areas, high traffic hallways, forklifts, etc. There are no environmental
> controls besides the use of hairnets and some basic cleaning procedures.
> The area is not currently classified and there is no environmental
> monitoring going on there.
> I've been asked if we can begin producing terminally sterilized (ETO)
> product in this area. My thought is that we need to demonstrate some form
> of control over the environment. I am considering proposing classifying
> this as a class 9 environment and performing routine particle and viable
> counts, as well as temperature and humidity limits.
> Can I build terminally sterilized product in a class 9 environment? Do I
> need a physical barrier of some sort between the clean zone and the rest of
> the factory even if I can demonstrate low enough particle counts? This is
> my first time working outside of class 7 and above rooms so I find myself
> at a loss. Any thoughts, references or advice would be appreciated.
> Best Regards,
> Justin
>
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and 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.
>
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> MilliporeSigma  http://www.emdmillipore.com/
>
> Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   -
> www.criver.com/micro
>
> Avista Pharma Solutions  http://www.avistapharma.com
>
> 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 Microbiology Network, Inc.,
> the PMF, or the sponsors of the list.
> This message and any attachments may contain PRIVILEGED AND CONFIDENTIAL
> INFORMATION of Protocol Link, Inc. If you are not the intended
> recipient(s), you are hereby notified that any distribution, copying, or
> disclosure of the contents of this message or any attachment containing
> privileged and confidential information is STRICTLY PROHIBITED. Please
> notify the sender immediately by e-mail and then delete this message.
>
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and 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.
>
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> MilliporeSigma  http://www.emdmillipore.com/
>
> Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   -
> www.criver.com/micro
>
> Avista Pharma Solutions  http://www.avistapharma.com
>
> 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 Microbiology Network, Inc.,
> the PMF, or the sponsors of the list.
>

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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.


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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro

Avista Pharma Solutions  http://www.avistapharma.com

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

ATOM RSS1 RSS2