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A basic design approach to Clean Room
efficiency and airflow rate. Clean rooms require very high efficiency filters and for class 100 and below, 100% HEPA filter coverage is recommended. HEPA (High efficiency particulate arrestance) filtration is 40% more efficient than the highest efficiency rated ASHRAE filter. Clean room air filtration technology centers around two types:
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Autoclaves Qualification & Validation
gmpua.com3 of 39 Autoclaves: Qualification & Validation Holger Fabritz - Expertentreff 14. September 2007 in Baden • Steam Autoclaves • Sterilisation with • Steam / Air Mixture • Saturated Steam • with possible initial vacuum sequence(s) • Cooling with • Air cooled down by heat exchanger • Hot Water Spray Autoclaves • Sterilisation with • Spraying of Water • (Flooding with water)
Pharmaceutical Process Scale-Up
gmpua.com81. Handbook of Pharmaceutical Granulation Technology, edited by Dilip M. Parikh 82. Biotechnology of Antibiotics: Second Edition, Revised and Expanded, edited by William R. Strohl 83. Mechanisms of Transdermal Drug Delivery, edited by Russell O. Potts and Richard H. Guy 84. Pharmaceutical Enzymes, edited by Albert Lauwers and Simon Scharpé 85.
PHARMACEUTICAL MANUFACTURING HANDBOOK
gmpua.comAnalytical Method Validation and Quality Assurance. Erik Van Bockstaele, Institute for Agricultural and Fisheries Research (ILVO), Scientifi c Institute for the Flemish Community, Merelbeke, Belgium, Analytical Method Validation and Quality Assurance. T. Vasconcelos, Laboratory of Pharmaceutical Development, BIAL, Mamede do
Batch Control Part 1: Models and Terminology
gmpua.commetric units in all new and revised standards to the greatest extent possible. The Metric Practice Guide, which has been published by the Institute of Electrical and Electronics Engineers as ANSI/IEEE Std. 268-1992, and future revisions, will be the reference guide for definitions, symbols, abbreviations, and conversion factors.
Pharmaceutical Cleanroom Commissioning, Certification, …
gmpua.comPurpose of the Pharmaceutical Cleanroom Thai Ministry of Public Health Food and Drug Administration: Pharmaceutical products should be manufactured under the requirements of good manufacturing practices by licensed manufacturers with the object of ensuring that users will receive efficacious, safe and good quality products.
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