Market Reports

Regulatory warning letters in pharma: What can we learn post-COVID?

A look at how the COVID-19 pandemic impacted FDA inspections and the trends that have now cropped up reflecting industry changes. Mirna Vazquez and Jessica Rayser from Charles River Laboratories reflect on these trends

Book your exhibitor space at Cleanroom Technology Conference Singapore!

Join leading exhibitors from the industry including Ecolab, Fisher Scientific, Micronclean, Tofflon, UV Medico, Guardtech Group, STERIS at this year's event

Cleanroom contracting: Should you look across the border?

There are many advantages to hiring a local contractor, but limiting your search to your country's borders may be limiting your potential. CRB's Rasmus Kidmose looks at the factors on either side of the discussion

A look at the US cleanroom market | Beyond the engineering

The infection control sector is intrinsically intertwined with the engineering sector, and any major change in demand and needs causes a domino effect in the other. The US market is a prime example and speaking to the experts reveals why

Containing potent product manufacture in a multi-product facility

With the source of HPAPI manufacturing in huge flux between big pharma players, specialised start-ups, and the trusty CDMO, companies need to appreciate the importance of a proper New Product Introduction strategy Metrics Contract Services' Anshul Gupte explains

Interview with BIM Manager Joe Murphy from Connect 2 Cleanrooms

As Building Information Modelling has become a more common practice, your BIM Manager has become more and more important. Joe Murphy talks about his career journey and some important lessons he has learnt in modelling a cleanroom project

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

Trending Articles

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    What is happening in the Indian cleanroom market: Schedule M, IPOs, partnerships and more Sophie Bullimore looks at the shifting regulatory pressures in the Indian cleanroom sector that are catalysing change across the sector
  2. Lifecycle approach to cleaning and disinfection rotation Regulatory requirements and guidance on disinfectant rotation varies from region to region. Walid El Azab, technical service manager at STERIS Life Sciences, considers the differences in how many disinfectants/sporicides are required and argues a lifecycle risk-based approach is more appropriate that an arbitrary one
  3. What is a semiconductor cleanroom sub-fab? The team at Jimmy Lea P/L discusses the unsung hero of hi-tech production, cleanroom sub-fabs, which require a strict design and construction plan
  4. Cleanrooms: solving the mystery of recurring low level contamination Dr Laurie Smith reviews her research that identified bacteria on cleanroom garments to solve the mystery of recurring low-level contamination in a facility
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    An A-Z of USP guidelines and best practice in compressed gas monitoring Blue Thunder Technologies breaks down USP standards, explores key risks, and outlines best practices for maintaining cleanroom compressed gas compliance and audit-readiness

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