Market Reports

Classification vs monitoring: What is the difference?

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

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 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

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

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

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?

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

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

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

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

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

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

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

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

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

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

Trending Articles

  1. 9 non-negotiables for hygienic cleanroom layout and design Michelle Locke from Teknomek and Tim Triggs of the Cleanroom Testing and Certification Board-International look at contamination control through the lens of cleanroom equipment
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    Pharmaceutical production compliance burdens nobody talks about Carl Andrews from Original Software investigates what FDA guidance and GAMP 5 require of pharmaceutical firms when software used in regulated environments is updated
  3. Upgrades, monitoring and more: Touring King’s College Hospital cleanrooms Sophie Bullimore gives the latest on the King’s College Hospital NHS Foundation Trust’s Aseptic Services Unit, and the future of its cleanrooms
  4. EXCLUSIVE: The journey to create Staubli's new robot for pharmaceutical manufacturing Julien Lora from Staubli talks to Sophie Bullimore about the development of the company's new robotic pharmaceutical solution, discussing the complexities of its launch as well as the pharmaceutical landscape it is launching into
  5. Cleanrooms: What is the difference between clean-up period and recovery time? The implementation of the new Annex 1, and references to the ISO 14644 family of cleanroom standards have raised questions around the "Recovery time" and the "Clean-up period." Nataša Štirn from Klimer and ICCCS Chair Conor Murray discuss

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