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Dr. Hans Schicht Ltd - Articles and news items

Trends in pharmaceutical cleanroom technology

Issue 1 2008, Past issues / 23 January 2008 /

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, so competently addressed by the pharmaceutical industry and cleanroom technology, are beginning to spread – and this again is a trend – into further areas of human endeavour such as hospital hygiene.

International standards: a tool for compliance

Issue 3 2005, Past issues / 22 August 2005 / 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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