Market Reports

Back to basics: Control your zones

The sanitation process varies depending on the industry, but Patricia Sitek from CR Konsulting talks about common ways to categorise areas in a facility from any sector, and some golden rules to follow for them

How do flexible film isolators shape up?

The ‘flexibility’ of flexible film isolators represent a real benefit in today’s rapidly evolving pharmaceutical landscape. Validating their use for APIs and HPAPIs means demonstrating that they can go toe to toe with rigid designs for operator protection. Written by Martyn Ryder

Assessing disinfection rotation at the point of use: Designing a field trial

Qualifications required for disinfectants consist of three phases: suspension tests, surface tests and field trials. The first two phases are well-described as either European or US standards, with surface testing against a range of representative surfaces being regarded as providing a more robust challenge than the suspension test. What is not described in any standard is the field trial. Written by Tim Sandle

Interview with Shawn Manuel | AirCare Automation

Connecting the technical and business sides of a company, Global VP of Sales for AirCare Automation, Shawn Manuel, discusses his view on the cleanroom controls sector

Interview with Stephen Pygott | Biopharma Group

Matching the customer to the product they need requires in depth knowledge of the wider concept of application. Airflow product specialist, Stephen Pygott, is one such expert whose laboratory centric background gives him an interesting and unique take on the safety cabinet market

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

Virucidal testing of cleanroom disinfectants

In “normal” times, with the exception of live vaccine manufacturers, control of viruses in cleanrooms is not usually the highest priority within contamination control. Viruses need a host to survive, as they are obligate parasites, just nucleic acid surrounded by a protein that can only replicate within a host cell, so their ability to survive on hard, dry surfaces is minimal. Contec’s Neil Simpson explains

The details of dust extraction in controlled environments

To choose the right machine, the nature of the dust and the statutory regulations for its handling and removal, as well as classification of the machine and filter technology, must be considered. Daniel Took from archer reminds us, the lower the Threshold Limit Value (TLV) for dust, the higher the health risk

A to Z of an effective monitoring programme

A successful monitoring process allows control of contamination for regulatory or product yield reasons. John Merrill from C2C explains monitoring results can be used for trend analysis by comparing data with subsequent air samples, and alert and action levels can be set for results outside of set acceptable thresholds

Clothing solution for EU GMP Annex I

Only single-use cleanroom apparel will help sterile product manufacturers improve compliance with the new guidelines, as Franck Bureth of Kimberly-Clark Professional explains

Jo Nelissen | ABN Clean Technology

In an interview, the founder and CEO of Belgium-based cleanroom engineering company discusses the issues of 2020 and his opinion on the growing cleanroom practices and technologies of today

Speaking opportunities for Cleanroom experts

Industry experts from the cleanroom industry are invited to submit their presentations for the Cleanroom Technology Conference in July

Germany market report | Supporting the vaccine race

A country that is taking on many fronts of the pandemic response, Germany has a well-known pharmaceutical landscape and an enviable cleanroom backbone. But is it enough?

Should technology based ARMMs be more widely adopted?

New technologies now exist that can reduce the time taken to detect viable particles by almost comical percentages, while also detecting and distinguishing inert ones. Therefore, it is puzzling why the uptake of ARMM devices in aseptic pharma manufacturing seems so slow

Validating VPHP bio-decontamination of FFP masks

DeconBox is a Vapour-Phase-Hydrogen-Peroxide bio-decontamination system that allows FFP2 and FFP3 masks to be reused. Riccardo Volta and Giacomo Nicolini from Comecer explain the process of validating the mobile, purpose-built system for use in controlled settings

Manipulators: A gamechanger in radiopharmaceutical production

For many years manipulator technology has stagnated, but recently, remotely controlled manipulator design has shown a leap forward. Jim Peterson from Central Research Labs discusses the variety of these machineries that help keep operators and radioactive material separate

Martin Birch and Peter Makowenskyj| G-CON Manufacturing

The modular construction movement is an unstoppable train at this point. In an exclusive interview, two G-CON Directors discuss the trajectory of this expanding technology, and how multiple global crises are changing business on both sides of the pond

AMC monitoring in fabs with spectroscopic methods

Airborne molecular contaminants clearly affect semiconductor yield and can’t be completely removed by modern filters in cleanroom fabs. Thomas Benoy from the $2.1m MetAMCII project says it is aiming to address the increasing need for measurement capabilities from the low ppb to the ppt in real time with low uncertainties

Cleanroom Conference and Manufacturing Chemist Live 2020 to go virtual

The virtual event taking place on 10-11 November 2020 will provide delegates with full access to the Manufacturing Chemist Live, Cleanroom UK, India and Singapore content and exhibitors

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

Trending Articles

  1. 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
  2. Airflow optimisation: What is it and is big pharma on board? Over-ventilating cleanrooms leads to exorbitant energy bills, Dan Diehl from Aircuity believes the dynamic air control technology now has a firm foothold in the pharmaceutical sector
  3. Fix for sterilising high-viscosity fluids Filtration can be an effective means of sterilising high-viscosity formulations using hydroxypropyl cellulose (HPC). Pall Corporation and Nippon Soda provide guidance concerning the selection of types of filter media and injectable grade HPC
  4. 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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    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

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