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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

January-February 1991; Volume 45,Issue 1

EDITOR’S PAGE

  • You have access
    Commentary on The USP's Proposed Microbial Limits for Aseptic Processing Areas
    J. P. Agalloco and J. E. Akers
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 1;

Research Article

  • You have access
    Fibrin Based Drug Delivery Systems
    Richard I. Senderoff, Ming-Thau Sheu and Theodore D. Sokoloski
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 2-6;
  • You have access
    A Total Organic Carbon Analysis Method for Validating Cleaning Between Products in Biopharmaceutical Manufacturing
    R. Baffi, G. Dolch, R. Garnick, Y. F. Huang, B. Mar, D. Matsuhiro, B. Niepelt, C. Parra and M. Stephan
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 13-19;
  • You have access
    Total Organic Carbon Measurement as a Substitute for the USP Oxidizable Substances Test
    Godfrey A. Crane, Marc W. Mittelman and Margaret Stephan
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 20-28;
  • You have access
    Dry Heat Inactivation of Rough Strain Lipopolysaccharide and Diphosphoryl Lipid A on the Surface of Glass
    John D. Ludwig and Kenneth E. Avis
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 35-40;

Technology/Applications

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    Sensor-Based System for Rapid and Sensitive Measurement of Contaminating DNA and Other Anaiytes in Biopharmaceutical Development and Manufacturing
    Jonathan Briggs
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 7-12;
  • You have access
    A Practical Approach To Supplier Quality Improvement
    Linda O’Riordan
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 29-34;

Review Article

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    Statistical Process Control for the Pharmaceutical Industry
    Mark Gershon
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 41-50;

Commentary

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    Product Sampling—Why Bother?
    William S. Schwemer
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 51-55;
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    Pre-Approval Inspections/Investigations
    Food and Drug Administration
    PDA Journal of Pharmaceutical Science and Technology January 1991, 45 (1) 56-66;
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In This Issue

PDA Journal of Pharmaceutical Science and Technology
Vol. 45, Issue 1
January-February 1991
  • Table of Contents
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  • Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media
  • Microbial Diversity in Pharmaceutical Product Recalls and Environments
  • Pharmaceutical Container/Closure Integrity II: The Relationship Between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials
  • Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials
  • Leak Testing in Parenteral Packaging: Establishment of Direct Correlation between Helium Leak Rate Measurements and Microbial Ingress for Two Different Leak Types
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