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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

July/August 2002; Volume 56,Issue 4

COMMENTARY

  • You have access
    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;

RESEARCH

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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;

TECHNOLOGY/APPLICATION

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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;
  • You have access
    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;
  • You have access
    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;
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In This Issue

PDA Journal of Pharmaceutical Science and Technology
Vol. 56, Issue 4
July/August 2002
  • Table of Contents
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  • COMMENTARY
  • RESEARCH
  • TECHNOLOGY/APPLICATION

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  • Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
  • Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes
  • Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement
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