Market Reports

Medical cannabis made in Italy

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

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

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

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

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

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

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

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

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

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
Andrew Davies | Microgenetics

Andrew Davies | Microgenetics

The Managing Director of biotech start-up Microgenetics is revolutionising microbiology with the use of machine learning and artificial intelligence to provide real-time analysis of environmental monitoring data
What is the scientific approach to cleanroom HVAC design?

What is the scientific approach to cleanroom HVAC design?

Nigel Lenegan of Energy & Carbon Reduction Solutions answered this question at the Cleanroom Technology Conference 2019 and his presentation is now available online
Draft Annex 1: Cleaning and disinfection clarified

Draft Annex 1: Cleaning and disinfection clarified

The preliminary version of the guidance for the manufacture of sterile medicinal products details core principles for cleaning and disinfection within a holistic contamination control strategy. Although a draft version, it would be prudent to plan validations with these core principles in mind. Contec's Karen Rossington explains
Coverage, buckets, and validation: The secret to mopping floor surfaces

Coverage, buckets, and validation: The secret to mopping floor surfaces

Contec's Dave Nobile on the best practices to render consistent desired outcomes
HVAC cleanroom design calculation explained

HVAC cleanroom design calculation explained

Mecart's Charles Lipeles dissects the key considerations to factor in the drawing board
Guide to wash-in-place process in horizontal mixing systems

Guide to wash-in-place process in horizontal mixing systems

Modular solutions are proven to reliably fulfil any industry-specific requirements in the pharmaceutical, food, cosmetics, and chemical industries. Sebastian Steinkamp of Lödige provides a step-by-step guide to effective cleaning

Trending Articles

  1. 9 non-negotiables for hygienic cleanroom layout and design Michelle Locke from Teknomek and Tim Triggs of the Cleanroom Testing and Certification Board-International look at contamination control through the lens of cleanroom equipment
  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. EXCLUSIVE: The journey to create Staubli's new robot for pharmaceutical manufacturing Julien Lora from Staubli talks to Sophie Bullimore about the development of the company's new robotic pharmaceutical solution, discussing the complexities of its launch as well as the pharmaceutical landscape it is launching into
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    Pharmaceutical production compliance burdens nobody talks about Carl Andrews from Original Software investigates what FDA guidance and GAMP 5 require of pharmaceutical firms when software used in regulated environments is updated
  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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