Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-04-02-2005
Volume 29
Issue 4
The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.
Articles in this issue
Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients
April 2005
Management Controls for GMP Compliance
The Sector Chart: A New Engineering Graph for Pharmaceutical Processes
Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays
PAT and Process Understanding: A Call to Arms
Cold Chain Concerns
Evolutions in Direct Compression
X-ray Microtomography of Solid Dosage Forms
Orient Express
Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms
Famine in Field Inspection
Establishing Target Fills for Semisolid and Liquid Dosage Forms
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