Market Reports

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

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?

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

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

Contec's Dave Nobile on the best practices to render consistent desired outcomes

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

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

Guide to energy-efficient cleanroom projects

New technology and design tools allow for delivering efficient and resilient manufacturing facilities without a cost premium. Matt Harris and Keith Beattie of EECO<sub>2</sub> explain

Debugging the effluent

Effluent decontamination systems are critical to the safe operation of a contained facility. Microorganisms can easily find their way into waste liquids and disinfectants are toxic, so what is the best way to manage it? Astell's Paul Birchmore explains

Trending Articles

  1. Harmonisation of Annex 1 and ISO 14644-1: A deeper look Alexander Fedotov from Invar explains that the harmonisation of standards seems to be a driving force for setting particle limits and why this may not always result in logical scientific decision making
  2. Airflow optimisation: What is it and is big pharma on board? Over-ventilating cleanrooms leads to exorbitant energy bills, Dan Diehl from Aircuity believes the dynamic air control technology now has a firm foothold in the pharmaceutical sector
  3. Fix for sterilising high-viscosity fluids Filtration can be an effective means of sterilising high-viscosity formulations using hydroxypropyl cellulose (HPC). Pall Corporation and Nippon Soda provide guidance concerning the selection of types of filter media and injectable grade HPC
  4. 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

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