Market Reports

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

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

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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