Market Reports

“There is a mindset shift in the market”

“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

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

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?

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

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

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

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

Semiconductor turns winemaker

Hiroshi Matsuzaka, CEO of former semiconductor plant in Japan, deploys ISO Class 5 cleanroom technology to winemaking
HVAC tip: sensor maintenance

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

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

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

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

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

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

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

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

Trending Articles

  1. Walking the tightrope: a look at air change rates How can companies design their cleanrooms in order to reach the air change rates required by ISO? Words by Simplex's Jerry Cross
  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. Virucidal testing of cleanroom disinfectants In “normal” times, with the exception of live vaccine manufacturers, control of viruses in cleanrooms is not usually the highest priority within contamination control. Viruses need a host to survive, as they are obligate parasites, just nucleic acid surrounded by a protein that can only replicate within a host cell, so their ability to survive on hard, dry surfaces is minimal. Contec’s Neil Simpson 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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