According to the USP1116
 '' All operators are aseptically gowned in these environments (with the exception of background environments for isolators). These  recommendations do not apply to production areas for nonsterile products or other classifed environments in which fully aseptic gowns are not donned.''

So you don't need to calculate recovery rate for C and D Grade Areas if you are not gown fully aseptic.

Nazlı Tekin 
Microbiology Team Leader


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Arda Sever
Sent: Wednesday, March 22, 2023 5:29 PM
To: [log in to unmask]
Subject: [PMFLIST] About USP<1116> Contamination Recovery Rate

DİKKAT: Bu e-posta kurum dışından gönderilmiştir. Göndericiyi tanımıyorsanız ya da içeriğin güvenli olmadığını düşünüyorsanız, linklere tıklamayınız ve ekleri açmayınız.

CAUTION : This email originated from outside the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.


Greetings to all fellow microbiologists.

I have a question regarding the Contamination Recovery Rate limits given in USP<1116> . While I am using the limits in our Grade B Filling Rooms (<5%), I am having trouble understanding how to expect a Grade C room to have
(<10%) recovery rate (90% of the control plates to be 0 CFU).

I would appreciate your opinions regarding this matter.

Sincerely,
Arda Sever.
Microbiology Specialist

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

Please take a second to visit our sponsors' web sites.  Let them know you saw them on our list and appreciate their support of this service.

If your company would be interested in sponsoring this community, please contact [log in to unmask] or by completing the sponsorship form here: https://bit.ly/3FsEVrW



Current Sponsors:

Associates of Cape Cod, Inc. - http://www.acciusa.com/

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

Novatek International https://ntint.com/

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

Veltek Associates, Inc - http://www.sterile.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.  Let them know you saw them on our list and appreciate their support of this service.

If your company would be interested in sponsoring this community, please contact [log in to unmask] or by completing the sponsorship form here: https://bit.ly/3FsEVrW



Current Sponsors:

Associates of Cape Cod, Inc. - http://www.acciusa.com/

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

Novatek International https://ntint.com/

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

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