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Cleanrooms - Articles and news items
Supplier news / 3 February 2016 / MOCON
Cleanroom operators will now be able to detect the presence of extremely low levels of microbial cells on surfaces much faster than traditional solutions…
Whitepapers / 15 January 2016 / Munters
Scandinavian Micro Biodevices (SMB), in Denmark, develops, produces and markets ‘point-of-care’ diagnostic systems for the veterinary market. In order to maintain a very low level of humidity in the clean room, a desiccant dehumidifier is required. An air quality of 5000m3/h must be maintained with the required condition of no more than 20% RH at 21°C, which corresponds to a water content of just three grams per kilogram of air. Munters’ solution is an MX5000 dehumidification system with pre and post cooling…
Supplier news / 7 December 2015 / Cherwell Laboratories
Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, has once again supported Pharmig’s Annual Conference…
Supplier news / 30 July 2015 / Cherwell Laboratories
Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, have announced the launch of a refreshed website….
The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.
This pharma webinar presents experts in the fields of monitoring and compliance and pharmaceutical water and cleanroom facility standards.
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) operators from the process. These methods are most often used during open processes or other critical process steps to ensure the product is not exposed to viable organisms and particulate contamination. While there are many methods to choose from, there is no argument that AAP techniques are widely used.
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.
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 energy savings issue was not widely acknowledged; managers wanted to see good compliance and high levels of production and spending time to save money; push for greater sustainability was not really welcomed. Now things have changed and there is a readiness to look at these issues, especially when it is proven that GMP and sustainability are not contradicting and on occasions, can go beautifully hand in hand.
Issue 5 2007 / 21 September 2007 / 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 and maintain the correct level of microbial contamination in the aseptic suite. This article focuses on two important issues – creating and maintaining a spore-free environment and preventing spore contamination that may result from the use of disinfectants.
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.
ABB Analytical Measurement ABL&E Group ABS Laboratories ACD/Labs ADInstruments Ltd Andor Technology Axis-Shield Diagnostics Ltd Bachem AG Biopharma Group Black Swan Analysis Limited CAMO Software AS Celsis International ChemAxon Cherwell Laboratories CI Precision Cobalt Light Systems Comark Instruments Coulter Partners DiscoveRx Dotmatics Limited Edinburgh Instruments Enterprise System Partners EUROGENTEC HunterLab Hyglos GmbH IDBS IONICON Analytik GmbH kbiosystems ltd L.B. Bohle Maschinen + Verfahren GmbH LabWare MKS Umetrics Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. Portalis Ltd Powder Systems Limited (PSL) ReAgent Source BioScience Spectrum®Labs.com Takara Clontech Thermal Detection Ltd. Tuttnauer Vaisala Ltd VIAVI OSP Waters Corporation Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Ytron-Quadro (UK) Limited Yusen Logistics