Market Reports

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

A modern take on sterility assurance

Pharmaceutical manufacturers are increasingly looking for strategies to address containment risks. Christian Dunne of ChargePoint Technology sheds light on the benefit of split butterfly valve technology (SBV) in the aseptic processing of sterile active APIs and the final product

Adaptable and fast builds from 2017

Many countries saw increased investment in new cleanrooms in 2017 but it was very sector specific. Meanwhile the application of new design and construction techniques has made the process faster, with fewer snags. Susan Birks summarises the year’s trends in cleanroom construction

Eco-friendly disposables wanted

Last year was a challenging year for the cleanroom apparel market, which was hit with changes in the PPE directive along with a call for more environmentally-friendly solutions. Charlotte Alldis rounds up 2017 most significant product launches providing a solution to these complex issues

Performance validation: HPAPI containment testing in a risk-based era

Taking a more automated approach to validation testing paves the way to capturing more repeatable and reliable data, thereby improving levels of containment performance

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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