Market Reports

Is fear of risk your biggest risk?

Risk-based decision making is essential to contamination control in manufacturing processes. Martin Lush, NSF International, explains why implementing SOPs that are risk smart is more beneficial

Testing for particles in injectable products

Liquid sample technology that is compliant with USP <788> must be part of any testing strategy into winning the war on contaminants within parenteral injectables. Jason Kelly, VP of Services, Lighthouse Worldwide Solutions, explains the technology and why companies should use it

Expert guide: Single-use supply chain risk management

Industry experts at Avantor describe a supply chain strategy to help drug manufacturers with multiple locations around the world manage and minimise the risk associated with the logistics of single-use systems while also ensuring regulatory compliance

Cleanroom validation: Quality of the product to the front

Cleanroom validation is a multifaceted project, so it is advantageous to have a dedicated project manager to lead, track, coordinate and schedule each step in a preplanned sequence. Ryan Burke, Analytical Lab Group, explains the process

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&#8200;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

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