Market Reports

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

Environmental monitoring: From sampling plan to data analysis

Axel Schroeder of Concept Heidelberg and Raphael Bar of BR Consulting analyse the steps to compliant EM monitoring ahead of the course EM Monitoring Data Management on 20-21 November hosted by ECA Academy in Barcelona

Joy McElroy | GMP Consultant

The US-based pharmaceutical manufacturing expert sets the record straight on quality assurance. “Quality is of utmost priority, and top-level management must understand this. We must teach GMPs to them,” she says

Opinion: Clothing solution for EU GMP Annex I

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

B.Braun Medical: The journey to a compounding aseptic production unit

Paul Bradley reviews the 24-month design, build and validation process that led the company to expand its Sheffield facility with two new Grade B production rooms increasing capacity by 70%

How to design a cleanroom monitoring system

This guide to designing a GMP-compliant cleanroom monitoring system is the first of a series of four articles about monitoring systems covering design, installation and validation, maintenance, and data interpretation

Trending Articles

  1. 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
  3. 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
  4. 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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    Agar plate desiccation: Causes, consequences, and practical solutions Yoggya De Silva from AnalytiChem company Cherwell, gives a guide to agar plate desiccation in cleanroom monitoring processes

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