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Market Reports
Bioanalytical strategy: Authorities’ expectations to consider
Dr Markus Fido, analytical characterisation expert and VelaLabs co-founder, looks at the product lifecycle of biopharmaceuticals to describe the methods manufacturers should use to ensure required safety and quality under Directive 2001/83/EC
Classification vs monitoring: What is the difference?
Understanding cleanroom classification and monitoring is critical to production and compliance. To prevent confusion between these two definitions, Hasim Solmaz, Lighthouse Worldwide Solutions, describes common and different points
A to Z guide to protective garments
Understanding, assessing, validating and auditing the entire value chain of cleanroom garments is critical to making sure they are fit to play their part in the manufacturing process. Steve Marnach and Matheus Barbosa, DuPont, explain
The cleaning power of plasma
The biggest issue in cleanrooms is particles landing on surfaces. Mike Hopkins, Impedans CEO, explains how the electric charge in plasma can be used to remove or reduce particles and even eliminate biological contamination on surfaces and equipment
Testing preservatives with PET
Tasmin Stock, Wickham Laboratories, explains the preservative efficacy test (PET), the specific challenges in preventing microbial growth and how partnering with experienced laboratories allows companies to comply with international regulations
The Legiolert protocol
A seven-year R&D programme has led to Legiolert, a new liquid culture testing technology that provides a faster method for detecting and quantifying <i>Legionella pneumophila</i> in water samples. Andrew Headland, Senior Business Manager for the IDEXX Water Division, EMEA, explains the method
Raising the bar for continuous environmental monitoring
Environmental monitoring (EM) is considered critical to all aseptic manufacturing environments where the sterility of the final product is paramount to quality and safety. However, the recently published draft of the new EU GMP Annex 1 now goes even further. Andy Whittard, Cherwell Laboratories, explains
Does your cleaning have the wettability factor?
Precision cleaning of printed circuit boards (PCBs) is required to meet stringent performance criteria. Mike Jones, VP MicroCare Corp, explains the “wetting Index” and how to determine the score of a fluid to measure its ability to clean complex shapes
Real-time particle fallout monitoring: Challenges and solutions
A patent-pending method based on CMOS sensor technology is set to revolutionise the monitoring of particle fallout in clean environments. Andrew Holland, XCAM, explains
Sensors meet hydrogen peroxide applications
The proprietary sensor technology in Vaisala’s PEROXCAP and HPP272 probe is a game-changer in bio-decontamination with hydrogen peroxide. Piritta Maunu, explains the advantages of its use to validate the integrity of rooms, isolators, RABS and transfer chambers
Interview: Colandis CEO Joachim Ludwig
From employee at Carl Zeiss to CEO of his own company, Joachim Ludwig has become an expert in cleanroom applications for technology industries. He believes unconventional solutions to client’s requests are key to a successful future in this market
Bye bye to biological indicators
For the last four decades, decontamination cycle performance validation has been based on placing biological indicators (BI) into the decontamination process. Phillip Godden, Protak Scientific CEO, explains why the use of enzymatic indicators (EI) is a solution to continuous monitoring of “fragile” hydrogen peroxide decontamination processes
Getting ahead of the regulatory curve for sterile compounded drugs
Kenneth Maxik, Director of Patient Safety and Compliance, CompleteRx, remarks on the sweeping changes to the USP in 2018 and the revisions likely to have the most significant consequences to clean environments
Easing energy consumption in cleanrooms
Monitoring energy use to benchmark yearly consumption in HVAC helps companies to meet today’s challenging regulations without compromising contamination control. Steve Wake, Director Validair UK, explains
Integrity testing of biosafety cabinets
What are the tests required for ensuring biological containment when working with biosafety cabinets? Ivan Kaliman, Managing Partner at Zwei Ingenieria, answers this question and describes key considerations for eliminating the risks
Fine tuning HVAC levels
Essential to product assurance and staff safety, HVAC needs within sterile processing areas must be addressed in compliance with current standards. Nancy Chobin, RN, AAMI Standards Developer Award winner 2018, explains what to watch out for when monitoring and maintaining temperature and humidity in these critical areas following the revision of the ANSI/AAMI ST79:2017 in the US
The future is gloveless for biopharma aseptic filling
Gloveless isolator technology for biopharmaceutical processes is getting traction in the industry thanks to the improved containment and flexibility for multi-product manufacturing that it delivers, John Harmer, Vanrx Pharmasystems, explains
Wash it away: Cleaning and disinfection in the food industry
Mike Taylor, Senior Chemist and Regulatory Manager, Christeyns Food Hygiene, explains the best practices for cleaning and disinfection in the food and beverage industry
Setting the scene for contamination control
An intelligent facility design can inhibit the entry, growth and spread of harmful microorganisms during food production. Pablo Coronel, Director Food Processing, and Dennis Collins, Architectural Practice Manager, CRB, look at the layout, construction materials and environmental controls
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
No dust allowed: when containment equipment is a must
AMI Environmental, a health and safety service firm, explains why it has chosen Hepacart as its go-to partner in controlling construction-related dust
Tristel: Proprietary chemistry paves the way for market share growth
Paul Swinney, Tristel CEO, is bullish on the outlook of the business. The British manufacturer of disinfection products is one step closer to entering the US market and a product innovation promises to expand its reach in the contamination control sector
Is your daily sterilisation routine eliminating your cleanroom as well as the contaminants?
Sue Springett, Commercial Manager, Teknomek, takes a more in-depth look at sterilisation routines and offers her opinion on how best to treat a cleanroom
ATP detection: The balance between precision and speed
Adenosine triphosphate (ATP) is an indicator molecule for the presence of biological residues used in food production. Burcu Yordem, 3M Food Safety, explains its role in an effective hygiene monitoring programme
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Trending Articles
The importance of growth promotion testing
Given the critical nature of microbiological quality tests which are employed to ensure that pharmaceutical products are safe for human use, it is in turn essential to undertake quality control (QC) tests to ensure that the culture media being used for these is fit for purpose and performs properly. Cherwell Laboratories' Steven Brimble explains
Guide to commissioning and qualification
The specific steps companies should follow to complete a cleanroom project, be it a new build or upgrade, are explained in this guide by Mack Powers, Integrao President
Cleanroom Technology Conference Singapore 2023: Day one review
Attendees from Asia and beyond attended the Cleanroom Technology Conference Singapore at the start of December. Those that did were in for a treat!
Cleanroom tightness and room pressurisation: Discrepancy?
A cascaded room-pressure regime has been considered for decades to prevent cross-contamination of different processes. But Harald Flechl from ISPE says today's tight cleanrooms must have leaks to ensure a room-pressure regulation - so why should we build tight cleanrooms?
How-to guide: Pass box qualification
Material transfer equipment plays an important role in minimising contamination risks during the manufacturing process. Industry expert, Jesus Casas, gives an overview of available pass boxes and a step-by-step explanation on how to qualify them appropriately
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