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Market Reports
Avoiding delays in your next cleanroom facility project
All the Gantt charts in the world can not make a cleanroom project run smoothly if things have been missed off them. Here are some tips from industry veterans to avoid setbacks from Mecart's Charles Lipeles
Isolators on a film set: An oddjob for Envair
Working as a film set consultant is not your average day for those in the controlled environment sector, but who better to bring a top-secret research lab to the big screen than the experts themselves. Envair's Susie Lee-Kilgariff talks about the experience
Common problems with the plate count method in cleanroom compliance
Traditional manual methods for microbial enumeration in monitoring cleanroom cleanliness have stayed relatively constant over the years, but what is changing this? Mark Newton and David Jones from Rapid Micro Biosystems explain
The regulations don't go far enough: Glove permeation testing in chemotherapeutics
Ansell Senior Director of Project Management, Eric Boeckmans, talks to <i>Cleanroom Technology</i> about why testing glove permeation ‘in-use’ is key to safe handling
Interview with lean construction expert Tammy McConaughy
The CRB Director of Lean Delivery discusses her training in the lean concept, her introduction to the cleanroom sector, and how the two are a perfect match
Understanding the demands of small batch sterile fill
Manufacturing drugs via small batch sterile fill-finish comes with unique considerations, but what are these, and what is the sector looking like after two years in a pandemic? Alex Garner, Khanh Ngo Courtney, and Frank Manella from Element explain
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
Choosing the right wipe for your cleanroom
In order for a cleanroom to sustain its appropriate cleanroom classification, employees not only have to follow stringent Standard Operating Procedures (SOPs) but also use the right products that are specifically designed for cleanrooms. Written by Ying Zhang
Using Computational Fluid Dynamics for challenging designs
Together with the increasing design technification and process optimisation is the need for a more accurate analysis and comprehension of physical phenomena, as well as an analysis of their very complex interactions. During the last few decades CFD has been widely deployed within several fields. Written by Miquel Vidaña
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Cleanroom hand tool selection: a practical guide to ISO 14644 compliance
John Basso, Director of Marketing at Sonic Tools, explains why verifying hand tool compliance before purchase is essential for maintaining cleanroom standards and avoiding costly disruptions
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
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
What are digital twins and what is their role in pharmaceutical production?
How can digital twin technology optimise pharmaceutical manufacturing operations. Stephan Nobis, Business Development Manager at automation supplier COPA-DATA, explains
Incubating settle plates: Understanding growth patterns and when things are going wrong
Steven Brimble from Cherwell Laboratories discusses why it is important to your environmental monitoring regime to understand growth characteristics of common cleanroom contaminants and how morphology shifts over time on various media
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