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In this RMMs & Environmental Monitoring In-Depth Focus: The rapid microbiological methods revolution; Controlling contamination in the pharmaceutical industry; Rapid Micro Methods Roundtable...
Lonza, a global leader in the field of biologics manufacturing, today announced the successful completion of its new GMP clean room within its Houston, Texas operations. The clean room supports multiple types of viral vector and viral vaccine projects, with working volumes up to 2,000 liters.
Changes in ISO 14644-1 to improve confidence in quality for critical life-science applications. Tony Harrison, UK Subject Matter Expert to ISO TC209 Working Group.
9 February 2012 | By HACH LANGE
This pharma webinar presents experts in the fields of monitoring and compliance and pharmaceutical water and cleanroom facility standards.
12 December 2009 | By Gavin Halbert, Director, Cancer Research UK Formulation Unit, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde
The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues…
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.
