Market Reports

Brexit trade bill: Not yet

The UK has decided it will continue to be involved with the European Medicines Agency (EMA) after Brexit. Paul Brooks, Executive Director at the Regulatory Affairs Professionals Society (RAPS) asks what does this mean for the pharmaceutical industry and patients after 2020?

Contamination control in satellite production

Satellite construction undergoes extraordinary changes as new technologies and increased demand alter their type and size. Susan Birks reports on future contamination control requirements following a visit to a cleanroom of Airbus UK

Antimicrobial materials to the front

Andy Newbould, Bioclad sales director, explains the benefits of antimicrobial technology applied to construction materials and highlights a recent project delivered for pharmacy premises at Midlothian Science Zone near Edinburgh, UK

Isolator sterility put to the test

Sterility testing must be carried out under strict aseptic conditions. Stacey Orley, Wickham Laboratories, describes the process to ensure products and devices are contaminant-free

How can new GMP regulations inspire and improve biosafety?

Henriette Schubert, global expert in process architecture, laboratories, biocontainment and GMP facility design at NNE, provides technical information on improving biosafety

The nanozyme that uses light to kill bacteria

Scientists at the RMIT University in Australia have created a nanozyme with antimicrobial properties with huge potential applications. Angharad Baldwin interviews Professor Vipul Bansal, lead researcher, to find out more

“Reusable cleanroom coveralls are the responsible choice”

Reusable cleanroom coveralls not only cost less than their disposable counterparts, a recently published study confirms they are the most sustainable option. Jerry Martin, Prudential Overall Supply, comments

Microbiologists put a question mark over chlorine washing

Researchers at Southampton University have found that chlorine washing of chicken is not sufficient to remove food contaminants

Making sense of particle counters

Understanding how particle counters work is crucial to making informed decisions in the operation of a cleanroom. Jason Kelly, director of systems, Lighthouse Worldwide Solutions, explains the technology and stresses the importance of data integrity

“There is a mindset shift in the market”

Rosaline Wijnen and Jo Nelissen, co-founders of ABN Cleanroom Technology, say increasing requests for modular cleanroom solutions and a greater concern for life cycle operational costs are the latest trends in the market

Clean slate for cleanroom design

How to design a cleanroom to meet the expectations of auditors and staff alike? Sue Springett, commercial manager at Teknomek, shares tips and tricks of the trade

Bearings: the inside matters

The demand for cleanroom automation equipment increases at a rapid rate with the growth of the medical and consumer electronics industries. Chris Johnson, managing director of SMB Bearings, examines outgassing and how to prevent contamination

VHP as sterilant for use in isolators?

Andrew Hopkins, senior GMP inspector, MHRA, explains the guidance around the use of vaporised hydrogen peroxide for sterilisation purposes

Contamination risks of dust explosions

Jhun Yparraguirre, electric discharge specialist, Dycem Asia, explains the use of dissipative flooring to prevent contamination from combustible or explosive airborne dust

Action plan for ATMPs

The new GMP guidance for advanced therapy medicinal products (ATMPs) will become effective in May 2018. Axel Schroeder, operations director at Concept Heidelberg, looks at current regulations ruling the biopharmaceutical and ATMP market and focuses on the most relevant to quality control

BIM under the microscope

Gavin Dunstan explores the unique challenges and potential pitfalls for operations managers when using building information modelling to deliver high-tech laboratories and manufacturing facilities for the modern scientist

Semiconductor turns winemaker

Hiroshi Matsuzaka, CEO of former semiconductor plant in Japan, deploys ISO Class 5 cleanroom technology to winemaking

HVAC tip: sensor maintenance

Pressure to reduce energy consumption in HVAC is mounting and so demand controlled ventilation (DCV) and free cooling are gaining popularity. Lars Stormbom, product manager at Vaisala, argues that optimal sensor maintenance is crucial to any energy savings strategy

Flooring made easy

A look at the many alternatives and the process for selecting the right flooring option for a cleanroom

Lowering university lab energy costs

Markus Schaufele, manager of standards, compliance and emergency planning for the office of research safety at Northwestern University, describes the system of choice to keep costs under control

Lifecycle approach to cleaning and disinfection rotation

Regulatory requirements and guidance on disinfectant rotation varies from region to region. Walid El Azab, technical service manager at STERIS Life Sciences, considers the differences in how many disinfectants/sporicides are required and argues a lifecycle risk-based approach is more appropriate that an arbitrary one

Checklist to comply with EU Biocides Regulation 528/2012

Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU BPR and any relevant national legislation before being placed on the market. Karen Rossington details the approval process and implications of the regulations

Addressing glass particulates in injectable drug formulations

Glass particles are a frequent contaminant risk when producing injectable drugs on high speed filling lines. Glassmaker Corning has studied the root causes and engineered a new glass product for use on existing equipment that significantly reduces that risk

Costing a cleanroom per square foot

Companies looking to build their first cleanroom will often ask a contractor for the cost of a cleanroom per square foot. However, costs can range from less than $100 to more than $1,000 per square foot. For those looking at their first build project, Mecart Cleanrooms has provided the following explanation for the difference in price

Trending Articles

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    Cleanroom hand tool selection: a practical guide to ISO 14644 compliance John Basso, Director of Marketing at Sonic Tools, explains why verifying hand tool compliance before purchase is essential for maintaining cleanroom standards and avoiding costly disruptions
  2. Cleanrooms: What is the difference between clean-up period and recovery time? The implementation of the new Annex 1, and references to the ISO 14644 family of cleanroom standards have raised questions around the "Recovery time" and the "Clean-up period." Nataša Štirn from Klimer and ICCCS Chair Conor Murray discuss
  3. 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
  4. What are digital twins and what is their role in pharmaceutical production? How can digital twin technology optimise pharmaceutical manufacturing operations. Stephan Nobis, Business Development Manager at automation supplier COPA-DATA, explains
  5. 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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