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Market Reports
How is laminar airflow technology enabling the industry to meet aseptic processing demand?
There is a growing demand for aseptic processing capacity; from both drug developers and their contract development and manufacturing organisation (CDMO) partners. This article explains how advanced technology, such as laminar airflow, can help the industry and its partners deliver the required cleanroom infrastructure that meets stringent global sterile integrity standards. Grant Merril from AES Clean Technology explains
From the client's perspective: designing an ISO Class 8 cleanroom
Univercells Technologies’ Head of Manufacturing & Supply Chain talks about his approach to building a scalable pharmaceutical manufacturing facility in Belgium. Gareth Crothers from Univercells explains
Top cleanroom projects of 2022
2022 saw some really inventive projects and solutions to problems. Taking a look back at some of the biggest and most innovative builds from cleanroom providers shows the standards for 2022 and there are definitely some standouts
Customising fume cupboards for EV battery recycling
Recycling research to make electric car battery usage more circular required a custom containment solution for the hydrofluoric acid produced. Susie Lee-Kilgariff from Envair explains
The importance of correct lubrication for cleanroom contamination control
Contamination events in pharmaceutical manufacturing can be extremely costly. One such area that introduces potential contamination risk if not managed effectively, is the use of bearing lubrication in equipment. Chris Johnson from SMB Bearings explains
The critical role of temperature monitoring in the pharma cold chain
Senior GxP Regulatory Expert from global measurement technology provider Vaisala discusses the challenges and describes solutions for both static and dynamic temperature monitoring in pharmaceutical cold chains. Words by Paul Daniel
ISPE GAMP5 second edition: What’s new?
General Manager of Lighthouse Worldwide Solutions, EMEA Operations, Hasim Solmaz takes a detailed look at the recently published IPSE Good Automated Manufacturing Practices
How accurate are CFD simulation results?
Having accurate Computational Fluid Dynamics results will inspire confidence in the decision-making process, so what does it take to ensure this? The Jimmy Lea team explains
Microbiological safety cabinets: Best cleaning protocol
What should you be doing to keep your Microbiological Safety Cabinets (MSCs) clean, and how often should you be doing it? Charis Hickey from Biopharma Group explains
The pain of change: Could disinfectant suppliers be part of the cure?
As an industry with safety as the primary concern, the pharmaceutical industry can often seem quite conservative, but should it be? Ecolab's Matt Cokely discusses
What you might miss when planning an in vitro coupon study
Disinfectant validation typically consists of two distinct testing phases; <em>in vitro</em> testing and <em>in situ</em> testing. It is important not to overlook any important considerations for these tests, STERIS' Richard Chai & Dave Shields explain
Using product inspection for quality control in liquid medicines
In liquid pharmaceuticals, the stakes could not be higher: the correct dosage and usage can literally be a matter of life and death. This article looks at how manufacturers and packaging companies in this field can harness product inspection to ensure they produce high-quality liquid pharmaceutical products. Mettler Toledo's Marco Pelka explains
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
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Trending Articles
The importance of growth promotion testing
Given the critical nature of microbiological quality tests which are employed to ensure that pharmaceutical products are safe for human use, it is in turn essential to undertake quality control (QC) tests to ensure that the culture media being used for these is fit for purpose and performs properly. Cherwell Laboratories' Steven Brimble explains
Guide to commissioning and qualification
The specific steps companies should follow to complete a cleanroom project, be it a new build or upgrade, are explained in this guide by Mack Powers, Integrao President
Cleanroom Technology Conference Singapore 2023: Day one review
Attendees from Asia and beyond attended the Cleanroom Technology Conference Singapore at the start of December. Those that did were in for a treat!
Cleanroom tightness and room pressurisation: Discrepancy?
A cascaded room-pressure regime has been considered for decades to prevent cross-contamination of different processes. But Harald Flechl from ISPE says today's tight cleanrooms must have leaks to ensure a room-pressure regulation - so why should we build tight cleanrooms?
How-to guide: Pass box qualification
Material transfer equipment plays an important role in minimising contamination risks during the manufacturing process. Industry expert, Jesus Casas, gives an overview of available pass boxes and a step-by-step explanation on how to qualify them appropriately
Upcoming event
Cleanroom Technology Conference UK
22–23 May 2024 | Conference and Exhibition | Birmingham, UK
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