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Market Reports
Checklist to comply with EU Biocides Regulation 528/2012
Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU BPR and any relevant national legislation before being placed on the market. Karen Rossington details the approval process and implications of the regulations
Addressing glass particulates in injectable drug formulations
Glass particles are a frequent contaminant risk when producing injectable drugs on high speed filling lines. Glassmaker Corning has studied the root causes and engineered a new glass product for use on existing equipment that significantly reduces that risk
Costing a cleanroom per square foot
Companies looking to build their first cleanroom will often ask a contractor for the cost of a cleanroom per square foot. However, costs can range from less than $100 to more than $1,000 per square foot. For those looking at their first build project, Mecart Cleanrooms has provided the following explanation for the difference in price
A modern take on sterility assurance
Pharmaceutical manufacturers are increasingly looking for strategies to address containment risks. Christian Dunne of ChargePoint Technology sheds light on the benefit of split butterfly valve technology (SBV) in the aseptic processing of sterile active APIs and the final product
Adaptable and fast builds from 2017
Many countries saw increased investment in new cleanrooms in 2017 but it was very sector specific. Meanwhile the application of new design and construction techniques has made the process faster, with fewer snags. Susan Birks summarises the year’s trends in cleanroom construction
Eco-friendly disposables wanted
Last year was a challenging year for the cleanroom apparel market, which was hit with changes in the PPE directive along with a call for more environmentally-friendly solutions. Charlotte Alldis rounds up 2017 most significant product launches providing a solution to these complex issues
Performance validation: HPAPI containment testing in a risk-based era
Taking a more automated approach to validation testing paves the way to capturing more repeatable and reliable data, thereby improving levels of containment performance
Telstar unveils 'smart' cleanroom HVAC system
Telstar has designed an innovative HVAC control system that provides automatic regulation in cleanrooms and saves over 40% in energy consumption
Jenoptik expands manufacturing capacity with new Class 5 cleanroom
Jenoptik has tripled cleanroom space at its Jupiter, Florida location to address increased global demand for optical systems
Protecting downflow booth performance for safe operation
Downflow booths provide a safe environment for workers handling potentially hazardous powdered raw materials but to ensure continuous safe operation, regular inspection and maintenance programmes should be in place. Hosokawa Micron highlights the main considerations
The acid test: pH measurement of water quality
For decades pH measurement has been the mainstay of water quality testing in cleanrooms and labs. However Mark Bosley, Business Support Divisional Manager, SUEZ Water Purification Systems, outlines some common pitfalls
Cleaning cleanrooms
Cleanroom cleaning requires many specialised products. Dr Tim Sandle, head of microbiology, Bio Products Laboratory, addresses the importance of product selection and cleaning techniques in the pharmaceutical manufacturing environment
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Trending Articles
GMP Annex 1: Validation of disinfectants on cleanroom surfaces
Published in August 2022, for implementation in August 2023, Karen Rossington from Contec looks at the revised version of EU GMP Annex 1 expanded and clarified the regulatory requirements of cleaning and disinfection in life science cleanrooms
What airflow design models are there for cleanrooms?
Sean Bartholomew and Matthew Penny from Germfree explain how airflow designs connect to overall facility flow, influencing the movement of personnel and materials within a cleanroom
Cleanroom attire: How to don and to doff, that is the question
Correct cleanroom attire is one thing, correct donning and doffing is another. Though the exact gowning SOPs can differ, the general steps remain the same. Arthur Lettinga and Egle Hammering from Elis Cleanroom run through the process
Continuous cleanroom monitoring: A look at automated settle plate handling
Continuous monitoring is becoming increasingly important in the most critical areas like class A and B of aseptic manufacturing or ATMP production, Miriam Schönenberger and Florian Blum from MVB discuss how it can be implemented in the best possible way
Incubating settle plates: Understanding growth patterns and when things are going wrong
Steven Brimble from Cherwell Laboratories discusses why it is important to your environmental monitoring regime to understand growth characteristics of common cleanroom contaminants and how morphology shifts over time on various media
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