PDA Journal of Pharmaceutical Science and Technology: 56 (4)

July/August 2002; Volume 56,Issue 4

COMMENTARY

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Recent Inspectional Trends: Are Regulatory Requirements for Sterile Products Becoming Scientifically Undoable or Unpractical?
James E. Akers and James P. Agalloco

PDA Journal of Pharmaceutical Science and Technology July 2002, 56 (4) 179-182;

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Helium Leak Test for Sterility Assurance of a Sealed Bag. I: Relationship of Helium Leak and Pinhole Diameter
Yasuhiro Miyako, Hideaki Tai and Izumi Saitoh

PDA Journal of Pharmaceutical Science and Technology July 2002, 56 (4) 183-191;

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Sterile Filtration – A Review of the Past and Present Technologies
Maik W. Jornitz, Peter G. Soelkner and Theodore H. Meltzer

PDA Journal of Pharmaceutical Science and Technology July 2002, 56 (4) 192-195;
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Determination of Residual Moisture in Lyophilized Protein Pharmaceuticals Using a Rapid and Non-Invasive Method: Near Infrared Spectroscopy
Tanya P. Lin and Chung C. Hsu

PDA Journal of Pharmaceutical Science and Technology July 2002, 56 (4) 196-205;
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Validation of the Scan RDI for Routine Microbiological Analysis of Process Water
Stephen P. Costanzo, Roya N. Borazjani and Patrick J. McCormick

PDA Journal of Pharmaceutical Science and Technology July 2002, 56 (4) 206-219;
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Wet Heat Inactivation of Lipopolysaccharide from E. coli Serotype 055:B5
Shinji Fujii, Masaki Takai and Takehiko Maki

PDA Journal of Pharmaceutical Science and Technology July 2002, 56 (4) 220-227;