Hans H. Schicht

Laboratorios Leti S.A.V. uses Ci-DMS from CI Precision

Trends in pharmaceutical cleanroom technology

There are many trends worth reporting in the context of…

23 January 2008 | By Hans H. Schicht, Dr. sc. Techn, Dr. Hans Schicht Ltd

There are many trends worth reporting in the context of pharmaceutical cleanroom technology: technical as well as regulatory trends. Supporting them is the continuing trend towards worldwide international standards, not only regarding contamination and biocontamination technology, but also regarding related topics such as air filtration. The endeavours for controlling micro-organisms,…

article

International standards: a tool for compliance

Regulatory guidance documents, such as Annex 1 to the GMP…

22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting

Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.

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Hans H. Schicht

Trends in pharmaceutical cleanroom technology

International standards: a tool for compliance