Market Reports

Isolator transfer design for ATMP products

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Trending Articles

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    Development, validation, and implementation: How to design your pharmaceutical facility disinfection programme The development, validation, and implementation of a robust disinfection programme are critical components of Good Manufacturing Practices (GMP). James Polarine, Matt Hofacre and Tony Cundell explain what you need to do
  2. 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
  3. A to Z guide to protective garments Understanding, assessing, validating and auditing the entire value chain of cleanroom garments is critical to making sure they are fit to play their part in the manufacturing process. Steve Marnach and Matheus Barbosa, DuPont, explain
  4. Precision cleaning explained Cleaning to perfection is a sophisticated process and yet vital to product integrity. Dr Brent Ekstrand, VP of Science & Technology at Astro Pak, sheds lights on contaminants and the tests performed to measure them
  5. Tips for particle concentration compliance under ISO 14644-1:2015 Apply these six steps to make your cleanroom fit for the new standard, says Hasim Solmaz, Lighthouse Worldwide Solutions

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