Market Reports

Annex 1: Changes that will hit EM monitoring programmes

Since 2017, Annex 1 Manufacture of Sterile Medicinal Products of EU GMP Volume 4 has been undergoing significant revision. In August 2022, the revisions were finally completed, and will become coming into operation in August 2023. But how do these changes change things? Microgenetics' Edward Webber explains

Less haste more speed: cGMP commercial facility design in 2023

The advancement of drug development techniques coupled with the need to deliver potentially life-changing therapies to patients efficiently has made the commercial facility design process increasingly challenging. DPS Group's Eric Quarnstrom explains

How to set up a project for handling highly potent products

In this article, three specialists from Litek focus on the field of primary containment that can be achieved with a suitable design of the process under isolator. Written by Javier Alonso Gómez, Alex García and Gastón Ariel Estruch

Interview with MSL Solution Providers' expert microbiologist Carolyn Burney

The Managing Director and microbiology expert talks about her experience validating disinfectants during a pandemic and taking over as Managing Director in its wake

Case study: Using dynamic air control in a cleanroom

A real-world utilisation of dynamic air control in a cleanroom, in this case study EECO2's Jamie Young explains how the system works and gives an update on how the regulatory compliance is going on this fascinating landmark project

Cleanroom Technology Conference Singapore: Day one review of the debut event

This debut outing of the event in Singapore for the contamination control sector fulfilled its promise to deliver a high-calibre programme to an international audience. Here is the day one review of what you missed!

Operating a cleanroom: Consuming consumables conscientiously

In sterile applications, it is sometimes not possible to eliminate disposables, but this is not a reason to give up. Andy Whittard from Cherwell Laboratories explains that there is a multitude of other ways to improve the sustainability of these processes whilst maintaining the required cleanliness

Interview with Ward Patton from cleanroom system expert Simplex

With a European modular cleanroom launch on the horizon, US-based Simplex Isolation Systems’ Director of Sales talks about trends in the cleanroom design & builds sector and his hopes and plans for the company to respond to them

Automating HEPA filter scans in barrier systems

Syntegon and InfraSolution discuss how the two companies have launched the first system for automated HEPA filter scans in barrier systems. Thomas Kosian and Christian Dorfner explain

Digital environmental monitoring: catch failures before they happen

There are many benefits to a day-to-day digital monitoring process, but how does it deal with a contamination event in the environment. This is where the benefits go from operational efficiency to operational agility explains Toon Lambrechts from MyCellHub

A guide to choosing the best particle sample point location

Particle counting in pharmaceutical applications can be clearly segregated into one of three categories: certification, qualification and monitoring. Each category requires a different approach as explained by PMS' Mark Hallworth

What is happening in the cleanroom market in 2022's DACH region

A look at the trends and major business deals through Germany, Austria, and Switzerland in a time of great turmoil across Europe

Interview with PathogenDx founder Milan Patel

The microarray testing company CEO discusses setting up a company and product to penetrate the microbiology testing market. The entrepreneur also dives into the importance of pathogen testing in the cannabis market

Opportunity mapping: Deploying risk analysis to improve transfer disinfection

A look at improving transfer disinfection and residue management, focusing on a UK case study following the use of the software at a pharmaceutical manufacturer and a demonstration of how areas for improvement can be identified and resolved

A systems approach to the future of cleanroom manufacturing flexibility

To help assure patient access to sterile injectable (SI) medications and meet the current needs of developers, aseptic facilities must be fit for a future of flexibility. What’s the secret to creating cost-efficient aseptic capacity and a facility that is truly flexible? Grant Merrill from AES Clean Technology discusses

Interview with HVAC filtration expert Andrew Marshall

UK-based filtration expert Triple Air Technology's Sales and Marketing Manager discusses his unconventional route into the cleanroom sector, how the pandemic changed the industry, and how environmental policies are impacting new builds

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

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