cell-2.jpg

You are here: Home > Search Keywords > Search Results
 
 
Simulated Media Challenge and Environmental Qualification of an Isolated Filling Line (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Jan. 27-28, 2000
 
Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission.
 
Qualification and Regulatory Issues for a CBER Licensed Isolated Filling Line (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Oct. 16-17, 2000
 
The regulatory process for the CBER licensing of an isolated filling line is discussed, including media fill data and FDA feedback from the pre-approval inspection (PAI) and FDA response letter.
 
Environmental Qualification and Monitoring within an Isolated Vaccine Filling Line (Presentation) by Les Edwards, MSE June 13-14, 2001
 
This section discussed the environmental qualification data and established action/alert limits for a vaccine filling system housed within an isolator. A comparison is made to conventional clean room monitoring techniques and limits.
 
Principles of Microbiological Monitoring in Isolators (Presentation) by Les Edwards, MSE July 2-3, 2003
 
This session discusses approaches to environment monitoring in isolator systems, including comparisons to conventional cleanroom aseptic process monitoring, measurement methods, alert and action limits, regulatory expectations, and related validation requirements.
 

back

 

 

Two locations to better serve clients worldwide.
 

USA Europe
150 Iowa Lane
Cary, NC  27511-4496
(919) 469-8876
(919) 469-4665 Fax
2 Avenue de Vignate
38610 Gieres, France
+33 4 76 63 48 74
+33 4 76 63 48 75 Fax

Brought to you by Advanced Barrier Concepts, Inc.

©2017 Advanced Barrier Concepts, Inc. All rights reserved.
Site Maintained By:
Bayfront Web Design

Administration