Market Reports

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

Guide to wireless dataloggers for thermal validation

New wireless dataloggers deliver accurate thermal mapping with time-saving benefits. Chris Maughan, MD of Thermal Compliance, explains

Passivation: An extra layer of protection for critical equipment

The cleaning process that removes iron from a surface layer of stainless steel alloy can play a pivotal role in biocontamination prevention. Astro Pak experts Daryl Roll and Dr Brent Ekstrand explain

Review: Cannabis Europa 2019

Scientists, businesspeople and politicians backing the regulation of medical and recreational cannabis have taken the stage of Southbank Centre this week to discuss research and business opportunities

Compound semiconductors: Let there be light, speed and power

UK companies get ahead of the curve with investments in R&D and fabrication infrastructure for next-gen electronics. Andy Sellars, Chief Business Development Officer, UK Catapult, explains the strategy

Register now: Lab Innovations celebrates Year of the Periodic Table

Event in Birmingham will feature 35 hours of educational CPD-accredited seminars and the Cleanroom Hub in partnership with <em><a href='http://www.cleanroomtechnology.com'>Cleanroom Technology</a></em> magazine

Procurement and GMP: A conflict in objectives?

A deeper understanding of the unique requirements and the underlying GMP guidelines is essential for purchasing in the pharmaceutical industry. Axel H. Schroeder of Concept Heidelberg, explains

Jim Polarine | STERIS Senior Technical Service Manager

Either chasing tornados or identifying microbial contamination, Polarine travels the world coaching how to put science into action. In this interview, he unveils what a good contamination control strategy looks like

RABS, isolators and the track-and-trace trend

Traditional aseptic production lines are a thing of the past. Isolators are being integrated with traceability systems to watch over safety of the product and the staff. Jorge Nuero of Telstar explains

Think before you wipe

There is no one-size-fits-all for wipes. Understanding facility priorities, material makeup and absorbency is essential to choosing the right one for the task, says Emily Peck of MicroCare

Butterfly valves: Containment and monitoring for API transfer

Michael Avraam of Chargepoint Technology writes about systems that are critical to preventing HPAPIs harming staff and the bottom line

Europe market report: Playing the waiting game

Demand for cleanrooms, products and services is on the rise in Europe despite Brexit uncertainty. Players in the region say biopharma and the new GMP Annex 1 requirements are key drivers of growth

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

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