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Cleanrooms - Articles and news items

Whitepaper: Changes to GMP force cleanroom re-classifications

Whitepaper: Changes to GMP force cleanroom re-classifications

Whitepapers / 3 March 2017 / Beckman Coulter

This whitepaper discusses the ISO 14644-1:2015 revisions impacting both the way the cleanrooms are classified and air particle counting instruments…

New microbial testing technology for cleanrooms announced by MOCON, Particle Measuring Systems

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…

Application note: Clean room dehumidification ensures reliable test results

Application note: Clean room dehumidification ensures reliable test results

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…

Cherwell highlights new cleanroom decontamination system at Pharmig

Cherwell highlights new cleanroom decontamination system at Pharmig

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…

Cherwell Labs

Cherwell launches refreshed website for Cleanroom Microbiology Solutions

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….

RMMs & Environmental Monitoring: In-depth focus 2013

Issue 4 2013, Microbiology / RMMs, Supplements / 21 August 2013 / Emanuele Selvaggio (Pfizer), Chris Delaney (Noonan Services Group)

The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.

Hach Lange 60x60

Whitepaper: New Support for ISO 14644-1

Whitepapers / 1 May 2012 / HACH LANGE

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.

Scientists / HACH LANGE logo

New monitoring methods improve compliance, reduce costs

Industry news, Webinars / 9 February 2012 / HACH LANGE

This pharma webinar presents experts in the fields of monitoring and compliance and pharmaceutical water and cleanroom facility standards.

Advanced Aseptic Processing: RABS and Isolator Operations

Issue 4 2008, Past issues / 2 August 2008 /

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.

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.

HVAC energy savings in the pharmaceutical industry

Issue 6 2007, Past issues / 23 November 2007 /

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.

Maintaining a spore-free environment in the cleanroom

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.

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