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Market Reports
US market report | A year full of problems, 365 days of solutions
Times are changing as the pandemic affects manufacturing at every level. US cleanroom suppliers are the thermometer to these changes, seeing the effects first as they have to meet increasing domestic demand in crisis conditions. Speaking to Claire Barber from PBSC, Bret Asper from Clean Rooms International, and Charles Lipeles from Mecart sheds light on the situation as it is today
Interview with Jessica Rayser | Charles River Laboratories
Microbial monitoring is key to a well functioning cleanroom. Project Manager for Charles River's Accugenix services, Jessica Rayser, goes into depth about sustainability in EM procedures, the pandemic, and the future of rapid microbial methods
Pharmaceutical reshoring: a healthy requirement, a strategic necessity
More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies, including how the pharmaceutical industry operates; Andrew Badrot, CEO of C<sup>2</sup> PHARMA, discusses the ongoing ramifications of the pandemic
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
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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
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?
HVAC cleanroom design calculation explained
Mecart's Charles Lipeles dissects the key considerations to factor in the drawing board
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!
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
Upcoming event
Clinical Pharmacy Congress
10-11 May 2024 | Conference | London, UK
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