I am wondering how companies are assigning their alert/action limits for pre-filtration bulk bioburden samples if data normally produces zeroes. Testing is performed as per USP <61>.
Is there an approach of considering the limits on the active raw materials/volume of WFI used to formulate/validated filter SAL or is it simply based on trending alone?
Alison Berman, MFS
Quality Control - Microbiology
[AMR_Logo_for Email Signatures_19DEC]
O 631.924.4000 ext. 379
[log in to unmask]<mailto:[log in to unmask]> \\ americanregent.com
CONFIDENTIALITY NOTE: This e-mail and any attachments are confidential and may be protected by legal privilege. If you are not the intended recipient, be aware that any disclosure, copying, distribution or use of this e-mail or any attachment is prohibited. If you have received this e-mail in error, please notify us immediately by returning it to the sender and delete this copy from your system. Thank you for your cooperation.
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]
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/
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.