From: Friedman, Rick L
Sent: Wednesday, November 12, 2003 1:02 PM
To: Butler, Jennie C
Subject: FW: Aseptic Processing -cGMPDraft Document Docket Number 2003D-0382 


-----Original Message-----
From: Vvvijay@aol.com [mailto:Vvvijay@aol.com]
Sent: Wednesday, November 05, 2003 9:57 PM
To: friedmanr@cder.fda.gov
Subject: Aseptic Proceessing -cGMPDraft Document


Rich,

I tried to call you but your number has changed.  I am not sure if I left you message at the correct extension.  I called mainly to talk about the cGMP public reveiw draft.

The IEST committee on Hepa Filters and Leak Testing (RP 001 & RP 034) ) met in Chicago the past few days. The committee members and I had some issues with the draft posted for public review.  In my capacity as Chair of these committees, I wish to communicate our comments:

1. Rating HEPA filters for particles greater the 0.3 um could significantly lower the allowed filter performance.  (line 308/309). We recommend following the definitions in the IEST RPs for HEPA filter as has been the common practice. 

2. Setting the leak threshold (0.01%) more severe than the overall efficiency (0.03%) could cause all filters to fail in the field (line 328).  I hope that the intent was to set the leak at or equal to the filter efficiency but for a larger particle size rather as written. 

I was unable to stay logged on long enough to send this comment via the docket as advices in the draft.  Since you were noted as one of the contact, I hope I am not bypassing any official protocol by sending these comments directly to you, Rich.

Regards,

R. Vijayakumar, Ph.D.
Chair IEST WG 001 and 034

Vice President
Technology & Marketing
Air Techniques International

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