Market Reports

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

Sitting down with TRU Cleanroom Cleaning co-founder Vanessa Morini

The Co-Founder of the cleanroom cleaning company in Genk builds on her process technology and validation expertise to explain why TRU is filling a gap in the market

Aseptic manufacturing: The robots are coming

Two collaborative projects between industry and two Irish universities are paving the way for autonomous robots in the pharma industry. Writes PM Group's Dave Wolton

Hi-tech cleanroom: Humidity control to the forefront

John Barker, Managing Director of Humidity Solutions, on the requirements to achieve high yield in the manufacture of lithium-ion batteries

Optimise desiccants with 3D validation software

Baltimore's CFD model brings predictive science to validation. Desiccants are tested for performance over time, bringing cost-efficiency to the forefront. Dr Mark Valentine explains

Amy Meysner | Glass Technology Services

The Chemistry Manager of the UK-based glass specialist discusses delamination risks and says only proactive companies can win the quality control challenge

DNA-driven pathogen detection for cannabis-hemp products

Shortcomings in traditional culture testing leave the industry in search of methods that can enumerate or count the presence of microbes whether dead or alive. Dr Jack Regan presents an alternative

Vision 2020: Cleanroom experts reveal expectations for the year ahead

Some of the leading figures in the contamination control industry comment on what lies ahead

Man or machine: The workforce of cleanroom 5.0

If full automation were technically possible, would it be legally achievable, ethically justifiable or economically sensible? The race between men and machine is on. Dr Gernod Dittel explains

Challenging disinfectant residues as per GMP Annex 1

Karen Rossington of Contec analyses commonly used cleanroom disinfectants to shed light on the best approach to tackle residues that are left on surfaces

Cleanroom technology for the IVF industry

<i>In vitro</i> fertilisation is a process that mimics nature and as such, the industry requires state-of-the-art facilities to control environmental conditions and prevent contamination of the “product”. Giles Palmer explains

Trending Articles

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    Battling biofilms in cleanrooms Michelle Locke from Teknomek discusses how it is possible to combat the persistent threat of biofilms with the right cleanroom furniture, equipment, and cleaning protocols
  2. Microbiological monitoring: Adapting to new rapid methods regulatory demands Dr Wan Li Low from Cherwell takes a look at the shift towards Rapid Microbiology Methods (RMM) and their validation
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    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
  4. 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
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    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

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