Market Reports

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

Cleanroom Technology Conference expands to Singapore

In addition to the big event in Birmingham, UK, there will now be a conference for those in the exploding market in Singapore

Medical cannabis made in Italy

Dr Fabio Di Francesco, a compounding pharmacist based in Rome, describes how cannabis is used in various dosage forms and the challenges ahead

Middle East market report: Oil-rich countries switch it up

The United Arab Emirates (UAE) and Saudi Arabia are top-tier economies in the Gulf turning to pharma and hi-tech industries to wean off lacklustre oil demand

Environmental monitoring meets sterility testing

Better processes and continuous EM methods are practical steps to overcome the challenges involved with sterility testing. Andy Whittard of Cherwell Laboratories explains how to approach these activities to mitigate the risk of a process failure

Cleanroom garments: Risk focus meets quality by design

A holistic approach for cleanroom garment validation spends more effort at the outset of design phase and on design qualification. Milenko Pavičić and Thierry Wagner of DuPont explain

Biocidal Products Regulation: Cleaning-up the marketplace

Bioquell's John Chewins explains how to sourcing chemical products for biodecontamination compliant with the legal framework

Trending Articles

  1. Guardtech and Elis: Taking over a cleanroom laundry build mid-project Originally contracted to develop just the cleanroom, Joe Shackley from Guardtech talks about taking the cleanroom laundry build after the original Principal Contractor was unable to fulfil the requirements
  2. 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
  3. 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?
  4. 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
  5. 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

Upcoming event

Pharmig Annual Pharmaceutical Microbiology Conference

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