PMFLIST Archives

November 2019

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:
Stephen Dragotakes <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 22 Nov 2019 10:52:14 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (121 lines)
Dear Reuven,
There is no specific requirement for Class C environments within current or
pending USP 797 or pending USP 825.
  Rather the emphasis is on the ISO-5 Primary engineering control, which
has an ISO-7 buffer room requirement in certain risk levels.
Face masks are required for entering compounding areas / buffer rooms
Currently USP 797 requirements specific to nuclear pharmacy are still in
effect.
USP requirements are for application to healthcare facilities, and nuclear
pharmacy.
They are not adequate or appropriate for pharmaceutical manufacture under
FDA Part 210/211/212 or under EUDRALEX.
For manufacturing the EU annex  recommendations certainly would be
appropriate.
Feel free to contact me if you have additional questions.


Stephen C. Dragotakes RPh, BCNP, FAPhA
[log in to unmask] , 508-361-9903

Facility Manager- Molecular Cancer Imaging Facility
Dana Farber Cancer Institute
27 Drydock Ave.
Boston, MA 02210
617-582-9615
[log in to unmask]

Radiopharmaceutical Consultant
Nuclear Pharmacist, Radiopharmaceutical Scientist, Sterile Compounding
Expert
Aseptic Processing Specialist, Registered Health Physics Service Provider
 MA Dept.Public Health Radiation Control Program.

dba Dragotakes Consulting
18 Hillcrest Rd.
Medfield,MA  02052



On Fri, Nov 22, 2019 at 10:06 AM Reuven Baum <[log in to unmask]> wrote:

> A nuclear pharmacy preparation room classified as  Class C, do the workers
> need face masks  all the time they are in the room or only when performing
> specific aseptic  tasks ?
>   I have trouble understanding the guides especially USP chapter 797 and
> the Emea Annex 1. Annex 1 suggests that in Class C a face mask is not
> needed.
> USP 797 is unclear to me in its recommendations on face masks.
>
>
> Thanks for any help.
> Reuven
> Yavne
> QC microbiology
>
> ------------------
> 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.
> If your company would be interested in sponsoring this community, please
> contact [log in to unmask]
>
>
>
> Science Advisory Board https://www.scienceboard.net/
>
> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.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.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

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

Charles River Laboratories - http://www.criver.com/

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

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

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

Boston Analytical http://www.bostonanalytical.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