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Hans-Joachim Anders - Articles and news items

Reducing microbial contamination via sterile risk assessment

Overview of rapid microbiological methods evaluated, validated and implemented for microbiological quality control

Issue 2 2011, Microbiology / RMMs / 19 April 2011 / Oliver Gordon, Jennifer C. Gray, Hans-Joachim Anders, Alexandra Staerk & Oliver Schlaefli, Novartis Pharma Stein AG and Gunther Neuhaus, University of Freiburg

The risk for patients through spoiled or otherwise adulterated pharmaceuticals has been acknowledged for many centuries and led to the establishment of Good Manufacturing Practice (GMP) and pharmacopoeial guidelines. Besides chemical purity, pharmaceuticals also have to meet microbiological standards, the latter primarily depending on the administration route. Drug products which are injected directly into blood vessels or tissues or that are applied directly into eyes and ears represent a greater infection risk than products which are administered orally or onto intact healthy skin. While parenteral drug products are required to be free from any viable microorganism (USP <71>, Ph. Eur. 2.6.1), oral and topical products are not required to be sterile, but are subject to strict guidelines limiting the number and types of acceptable microorganisms (USP <61> and <62>, Ph. Eur. 2.6.12 and 2.6.13).

Polyphasic approach to microbial identification

Issue 6 2006, Past issues / 28 November 2006 / Hans-Joachim Anders, Marion Keller, Manfred Berchtold and Werner Hecker, Novartis Pharma Stein AG, Biological and Microbiological Services, Switzerland

The identification of microorganisms from the pharmaceutical production environment has gained an ever greater importance in modern times. Thus the new Aseptic Processing Guide of the FDA recommends the identification of detected isolates from the critical clean room area (grade A or ISO 5) down to the species level and recommends the identification of isolates from the surrounding lesser controlled clean room area (i.e. grade B or ISO 7) down to at least the genus level.


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