Tony,
Could you please forward me a copy of the PhRMA survey in which you are a co-author. My address is
K. R. Gurijala
Director of Microbiology
Quality Control Laboratory
Alpha Therapeutic Corporation
2450 Lillyvale Avenue
Los Angeles, CA 90032
Thank you very much.
Rao
K. Rao Gurijala, Ph. D.
Director of Microbiology QC
323-227-7277 Phone
323-227-7009 Fax
626-253-6192 Mobile
877-547-6340 Pager
E-mail: [log in to unmask]
>>> [log in to unmask] 03-May-01 5:20:21 AM >>>
Carol,
I was a co-author of a PhRMA survey on EM in non-sterile manufacturing areas. You may wish to refer to it:
Tony Cundell
Wyeth-Ayerst
Anderson AS. Bassett G. Burke
MT.Cotton ML. Cundell AM. Dammers F.
Deschenes R. Home Flood M. Greene M.
Karaim M. May J. Mestrandrea LW.
Metzger L. Miller KS. Munson JW.
Orlowski SJ. Price JM. Schady K. Shirtz J.
Vanjonack WJ. M. Williams RR. Winely
C. Wilson JD. White T.
Microbiological monitoring of
environmental conditions for nonsterile pharmaceutical manufacturing. Pharmaceutical
Technology. 21(3) (pp 58-74+10), 1997
>>> Carol Lihs <[log in to unmask]> 05/02 4:11 PM >>>
Greetings to all--
Can anyone see the advantage to doing RODAC plates on walls in a packaging
area for a non-sterile solid oral dosage form? I really think that air sampling
would give more valuable results in this situation but I can't seem to get my
point across. I'm discussing this with some non-microbiologists who are (I
think) confusing our packaging area with a Class 100 Clean Room. Help, I
really need some opinions from the experts.
Carol Lihs
Sr. Microbiologist
GlaxoSmithKline
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