Market Reports

Lifecycle approach to cleaning and disinfection rotation

Regulatory requirements and guidance on disinfectant rotation varies from region to region. Walid El Azab, technical service manager at STERIS Life Sciences, considers the differences in how many disinfectants/sporicides are required and argues a lifecycle risk-based approach is more appropriate that an arbitrary one

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

Trending Articles

  1. A review of innovations in sustainable cleanroom operations Nash Mader from Instant Cleanroom Solutions lists the notable sustainability trends and innovations in action in cleanroom projects in 2025
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    Sporicides: Optimal criteria for cleanroom users In addition to basic chemicals and formulation, there are other criteria that contribute to making something a sporicide. Tim Sandle, in partnership with Ecolab Life Sciences, explains what you need to know
  3. Tips for particle concentration compliance under ISO 14644-1:2015 Apply these six steps to make your cleanroom fit for the new standard, says Hasim Solmaz, Lighthouse Worldwide Solutions
  4. 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
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    Annex 1 and “first air”: What is it and how is it used? First Air as a concept is a major update in the new Annex 1 to continue global harmonisation of regulatory standards, but what is it and how is it used in the new document to improve clarity and compliance? Josh Russell, VP of Sales and Marketing at AST discusses

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