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Market Reports
20 questions with Lonza HPAPI containment expert
An in-depth discussion about Highly Potent APIs (HPAPIs) and their containment with Christian Dowdeswell VP, Head of Commercial Development, Small Molecules at Lonza
A guide to common sterile processing contaminants
Why are some organisms more common cleanroom and sterile processing contaminants? To understand this, we must look to Darwin as Chris Bartlett from Lexagene explains
Harmonisation of Annex 1 and ISO 14644-1: A deeper look
Alexander Fedotov from Invar explains that the harmonisation of standards seems to be a driving force for setting particle limits and why this may not always result in logical scientific decision making
How to analyse limit breaches
Environmental monitoring limit breaches are one of the first things quality control professionals look at when reviewing their data. But how do you set these levels to determine the state of microbiological control within the cleanroom? Microgenetics' Edward Webber explains
Interview with David Lindholm | KeyPlants
The Head of Sales with a history of chemical engineering and working at pharmaceutical CDMOs, discusses the demand for shortened lead times, the benefits of the company’s recent acquisition, and putting yourself in the client’s shoes
Cleanroom target setting for a sustainable facility
COP26 has reinforced how catastrophic world climate change has to be addressed by all sectors. With reports at the conference stating that life sciences contribute more CO<sub>2</sub> emissions than even the semiconductor industry, this especially applies to cleanrooms and their management. Jamie Young from EECO<sub>2</sub> explains
Vision 2022: new year, new cleanroom
What are likely to be the top headlines of 2022? From new design concepts, to global shortages, to fresh businesses popping up worldwide. If 2020 was a global emergency and 2021 was the recovery, 2022 is looking to be the renaissance
India cleanroom market report | Nothing but potential
The current focus on quality improvements and localised production in India are happening alongside the huge boom in demand. Cleanroom consumables and equipment providers in the region talk about their experiences with this and their interest in how the post-pandemic era will play out
Interview with Ian Mutton | Felcon
The Managing Director of equipment specialist Felcon has been with one company for over 35 years, growing it year on year, so when he talks about his take on supply chains, business, and custom solutions, his word should be valued highly
Interview with James Bornholdt | CRB
The Director of SlateXpace Global Operations walks us through his career, from being a newbie in the world of controlled environments, to taking the spotlight in a COVID-19 vaccine facility build, and finally to being in charge of the launch of a whole new construction concept
Disinfectant efficacy testing: US vs Europe
There are many standard disinfectant efficacy test methods available in both Europe and the United States but the testing approach is very different and using the tests in the opposing regions is not so easily accepted. Karen Rossington from Contec explains
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
The emergence of IT/OT Devices in GxP environments
Biometric monitoring devices, smart glasses, wireless access points, and mobile devices are making their way into GxP environments just as they are becoming a part of most other aspects of daily life. Emily Patterson from Grantek explains
Interview with ASAP Innovations | Madan Natarajan
In the eye of the COVID-19 storm, the General Manager and Director of Malaysia-based glove specialist talks about all things pandemic and why supply chain management was the name of the game
Time to market: implications for a new cleanroom build
The primary driver for any manufacturing cleanroom facility build is “Time to Market” and the decision making process for this follows a consistent business cycle of (1) plan cycle, (2) build cycle, and finally (3) operation cycle. But it is far more complicated than it seems as Sandeep Davé from AM Technical Solutions explains
Interview with Don Donovan | Camfil
The company’s President of EMEA speaks about his 32 years in the industry, upcoming trends he is anticipating, and why companies should get over their fears and implement adaptive air change rates. Written by Sophie Bullimore
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Development, validation, and implementation: How to design your pharmaceutical facility disinfection programme
The development, validation, and implementation of a robust disinfection programme are critical components of Good Manufacturing Practices (GMP). James Polarine, Matt Hofacre and Tony Cundell explain what you need to do
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
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
Precision cleaning explained
Cleaning to perfection is a sophisticated process and yet vital to product integrity. Dr Brent Ekstrand, VP of Science & Technology at Astro Pak, sheds lights on contaminants and the tests performed to measure them
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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