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2 August 2008 | By
Advanced Aseptic Processing (AAP) is a term referenced in the recently published ISPE RABS definition1 to cover the spectrum of Restricted Access Barrier Systems (RABS) and isolator systems. In general, AAP techniques are physical barrier methods of product protection and containment that are used during manufacturing operations to separate (primarily)…
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,…
23 November 2007 | By
Proper and compliant HVAC systems are fundamental to the pharma industry as we use high air change rates to secure a low viable and particle contamination. HVAC is energy consuming and therefore the HVAC accounts for a large proportion of the energy used in pharma facilities. In the past the…
21 September 2007 | By Karen Rossington, Marketing and Development Manager, Shield Medicare Ltd.
The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create…
27 March 2007 | By John Neiger, Technical writer and consultant
It is some years since the ISO 14644 and 14698 series of international cleanroom standards started taking over from national standards. Early parts are already undergoing their statutory five-year reviews; other parts have only recently been published and new parts are still being written.
24 March 2006 | By Bengt Ljungqvist, Ph.D. and Berit Reinmüller, Ph.D. KTH Stockholm
To verify that cleanroom and clean zones are adequately installed and functioning they are usually validated during three occupancy states. First, when the installation is complete with all services connected and functioning, as-built; secondly during at-rest conditions when equipment is installed and running in a manner agreed upon by customer…
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.
