Market Reports

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?

Milos Perovic | Termovent

In an interview with Cleanroom Technology, HVAC specialist COO and Head of the Cleanroom division was proud to discuss the behind-the-scenes importance of controlled environments during a time of pandemic

The evolving role of a contamination control strategy in Annex 1

A Contamination Control Strategy is a cyclical process designed to prompt the manufacturers to identify and resolve risk. With the 2020 draft update to Annex 1, David Keen from Ecolab looks at the interesting specific impacts of the changes on the role of a well-designed CCS

Adoption of rapid methods for QC microbiology in biopharmaceuticals

Rapid turnaround times and high sensitivity are essential for microbial QC testing. David Jones from Rapid Micro Biosystems explains that by the time a traditional test is completed, it can be difficult to rewind several days into the past and pinpoint the cause of a contamination event

The benefits of decentralised air handling

Performance requirements and sustainability targets can sometimes be at odds in the cleanroom world, but decentralised air handling system design can actually benefit both says Connect 2 Cleanrooms' Sam Armer

Cleanroom Conference and Manufacturing Chemist Live events set to go ahead

The co-located events will go ahead in October with new safety measures in place, after being postponed from their original date at the start of summer due to COVID-19

Nano-copper technology for antimicrobial surface design

Research has shown that copper ions are released when microbes land on a surface and can kill them, but regular copper can cause an uneven surface that is ideal for the microorganisms to adhere to. Selina Ambrose from Promethean Particles discusses nano-copper as a novel technology aiming to address this with liquid dispersion

Isolators: The beginnings of a new trend in Asia

To date, very few filling and closing machines have been installed in Asia. Aprogen Biologics and Optima Korea are both convinced that this will soon change as they install an isolator system in South Korea

Reginald Fernandes & Jamie Tempest | Reading Scientific Services

When taking its first venture into cleanroom technologies and sterility testing, RSSL picked a balanced team of microbiologists with different specialisms to guide them

UK market report: Cleanroom business from Brexit to COVID-19

Uncertainty is a word all UK operators are well-acquainted with by now, from Brexit to a global pandemic. Speaking to directors of companies in the thick of it shows how resilience and preparedness is helping them transition to the ‘new normal’

Isolator transfer design for ATMP products

A challenge posed by the increase of closed systems is the transfer of semi-finished products without losing the aseptic conditions required by regulations. A new study has tested a transfer system aiming to offer biocontainment without losing cell viability of ATMP products

Putting disinfectant to the test: Designing a field trial

Cleaning and disinfection is a process that can become very elaborate in cleanrooms. Tim Sandle in conjunction with Ecolab Life Sciences discusses designing a thorough and reliable field trial to test this process

Annex 1: How v.12 update impacts cleanroom cleaning and disinfection

The latest draft of sterile manufacturing guidelines may change again, but Matt Cokely from Ecolab says the direction of travel for the guidance is reasonably clear with regards to the guidance for cleaning and disinfection as an integral part of a Contamination Control Strategy

Contamination in a changing food production industry

The European food sector has changed significantly over the last three years. The influence equipment manufacturers have had on cross-contamination and standard cleaning requirements is key to enabling these advances

Cleaners and carrier fluids: Preventing contamination in medical device production

Modern cleaning and coating fluid technologies and associated vapour degreasing equipment provide consistent and reliable device cleaning. However, these modern cleaning fluids offer added benefits beyond this

COVID-19: Testing for surface and air presence

Protecting healthcare workers against coronavirus requires a multi-faceted approach. Rapid testing technology for aerosolised and surface virus are two ways that ensure detection for an effective management strategy

Annex 1: How new draft impacts cleaning and disinfection in cleanrooms

The v.12 draft update to EU GMP Annex 1 has laid out how cleaning and disinfection should be considered ‘together’ within a documented contamination control strategy

Halden Shane | TOMI Environmental Solutions

Leading a decontamination company during an infectious disease outbreak is no mean feat. Founder and CEO of TOMI, Dr Halden Shane, explains why its Ionized Hydrogen peroxide is a great weapon in your arsenal

Guide to implementing a VHP system for facility biodecontamination

Vaporised hydrogen peroxide biodecontamination systems can be installed and integrated into a plethora of cleanrooms or suits. Here John Klostermyer, VHP Application Project Manager at STERIS, provides some tips for drafting a process-oriented User Requirement Specification

Social distancing in a lab

While rigorous hygienic standards are already in place, new practices are required to help those in the cramped confines of cleanrooms and labs during the COVID-19 pandemic. Sue Springett, Commercial Manager at Teknomek, discusses what needs to be evaluated; such as the problems in crowded gowning rooms and the conflicts of priorities with air flow

Gaby and Ute Schilling | Schilling Engineering

German cleanroom company Schilling Engineering was founded more than 20 years ago. Now the founder and CEO is preparing his twin daughters to become his successors

API production: Cleaning equipment between batches

Cleaning is an essential part of the API production and it’s important to ensure that all traces of the previous batch are removed before the start of the next one, Pat Downs, Cleaning Co-ordinator at Cambrex discusses

Matts Ramstorp | BioTekPro

The CEO of the Swedish training and consultancy company looks back on 30 years in the business and argues the “know-why” is the real knowledge gap in the market

US market report: Biologics and sustainability lead the way

The sentiment is positive among cleanroom solution providers because influx of projects comes from all market segments, and there is further growth in emerging applications

Trending Articles

  1. Pharmaceutical waste: What do I do with it? Emma Cooke from Envirovue discusses the many hazardous elements of pharmaceutical waste and the importance of effective management and compliance
  2. Pharma sector uses AI agents to reduce IT incident response times, says KTSL Aaron Perrott, CTO at KTSL, explains how pharmaceutical companies are using AI agents to improve IT response times, reduce MTTR and support faster clinical and operational workflows
  3. 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
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    Annex 1 and “first air”: What is it and how is it used? First Air as a concept is a major update in the new Annex 1 to continue global harmonisation of regulatory standards, but what is it and how is it used in the new document to improve clarity and compliance? Josh Russell, VP of Sales and Marketing at AST discusses
  5. Incubating settle plates: Understanding growth patterns and when things are going wrong Steven Brimble from Cherwell Laboratories discusses why it is important to your environmental monitoring regime to understand growth characteristics of common cleanroom contaminants and how morphology shifts over time on various media

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