Market Reports

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

Interview with Katie Mills | Schneider Electric

The Head of Sustainable Development & Innovation for the UK and Ireland, at Schneider Electric has a lot to say when it comes to how controlled environments can take responsibility for their carbon footprint

The characteristics of water purity levels and how to verify them

Water is one of the most important variables in a controlled environment for maintaining cleanliness and even the most robustly conceived project can be fatally undermined by a lack of due attention. Mike Seed from Elementar explains

No space exploration without cleanrooms: What makes them so special?

The success of newcomer companies such as SpaceX shows one thing above all: there is a spirit of optimism in commercial space travel and there is one sector that will benefit from the growth of the aerospace market: cleanroom technology. Gernod Dittel and Berthold Vogt from Dittel Engineering talk about how the sectors works together

Technical cleaning as part of data centre particulate matter control

Most companies own varying amounts of IT and data equipment, representing a large investment to an organisation. This equipment is often referred to as ‘Mission Critical’, and the need for uninterrupted use essential, but contamination events can obstruct this. Stephen Yates from IT Cleaning explains

Interview with Samuel Hussain | MRC Systems

Global Sales Manager for cleanroom contractor MRC Systems talks about the geographical benefits of a UAE headquarters, his prioritisation of a collaborative attitude, and the debate on the extent to which prefabrication should take place

Trending Articles

  1. 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
  2. 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
  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. 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
  5. Costing a cleanroom per square foot Companies looking to build their first cleanroom will often ask a contractor for the cost of a cleanroom per square foot. However, costs can range from less than $100 to more than $1,000 per square foot. For those looking at their first build project, Mecart Cleanrooms has provided the following explanation for the difference in price

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