Market Reports

A justified process for cleaning and disinfection

Is a separate and distinct cleaning step always needed before disinfection? STERIS' Walid El Azab explains the scientific approach for choosing the appropriate method for cleanrooms and non-contact product surfaces

US market report: Flexing the muscle

Big ticket R&D projects in biopharma are the main driver of business for cleanroom solution providers in the US. The need for particle-free manufacturing spaces adds to the optimism in the market

A recipe for materials handling facility design

Pharma companies planning an oral solid dose production facility are challenged by different options for the layout. Richard Lockwood, Pharmaceutical Business Line Director, Matcon, explains the considerations for a materials handling area

Adopting cleanroom technology for safer medicinal cannabis

PAC's Mitch Walleser explores the building materials in hyper-clean grow rooms improving medical cannabis yield

How-to guide: Pass box qualification

Material transfer equipment plays an important role in minimising contamination risks during the manufacturing process. Industry expert, Jesus Casas, gives an overview of available pass boxes and a step-by-step explanation on how to qualify them appropriately

Particle counter management for better data integrity and reliability

Jason Kelly, VP of Services, Lighthouse Worldwide Solutions, reveals the best housekeeping methods that users of particle counters can apply to help mitigate against loss of data integrity and accuracy

Cleanroom suitability: Making it right for the process

Joachim Ludwig, Colandis CEO, explains what it takes to determine the compatibility of machinery, supplies and tools for use in a cleanroom given air cleanliness required by ISO 14644

Air filtration to the test

Camfil’s Alan Sweeney looks at the benefits that the new global standard ISO 16890 brings to clean processing environments and why companies should incorporate the norm into SOPs

An eco-friendly solution to microbial contamination

The world-first 100% mineral antimicrobial technology is the brainchild of Pylote, the French chemistry specialist. The breakthrough delivers an effective answer to the prevention of surface microbial contamination that is good for the environment

Clean cleaving in the nanofab

A new tool offers nanofabrication staff a cost-efficient process for wafer downsizing and preparing samples in the cleanroom without compromising the cleanliness of the production space or the wafers

Pseudalert: A one-day test method for P. aeruginosa

Pseudalert is a method powered by a unique bacterial enzyme detection technology that provides confirmed results in 24 hours. Developed by IDEXX to be carried out onsite healthcare settings, it has become the ISO standard for water quality, detection and enumeration of Pseudomonas aeruginosa

Injectable drugs: Stability, sterility and shelf life boost with flexible packaging

Pharma companies are turning to flexible structures for packaging injectable medicines due to new technology provides improved stability, sterility and shelf life over the glass counterpart. Robin Van Landeghem explains

A bold move to handle HPAPIs

Amadeo Ferreira, R&D Manager at Minakem, explains the design of its new manufacturing plant in Belgium featuring a containment strategy that protects both the product and the staff

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

Laundered mops: A question of performance

The properties that make a microfibre product a good cleaning tool also make it nearly impossible to be cleaned. Karen Rossington investigates this paradox and sheds light on the benefit of choosing the single-use alternative

Containment strategy for highly potent API manufacturing

The continued proliferation of HPAPI molecules means pharmaceutical companies, and their development manufacturing partners, must implement efficient and detailed procedures for containment. Maurits Janssen, Lonza Pharma & Biotech, explains

The non-thermal way to kill bacteria

High hydrostatic pressure and pulsed electric fields are alternatives to traditional thermal pasteurisation. Professors Henry Jäger and Felix Schottroff explain how these technologies work and present cold plasma as an emerging surface decontamination tool

Is fear of risk your biggest risk?

Risk-based decision making is essential to contamination control in manufacturing processes. Martin Lush, NSF International, explains why implementing SOPs that are risk smart is more beneficial

Testing for particles in injectable products

Liquid sample technology that is compliant with USP <788> must be part of any testing strategy into winning the war on contaminants within parenteral injectables. Jason Kelly, VP of Services, Lighthouse Worldwide Solutions, explains the technology and why companies should use it

Expert guide: Single-use supply chain risk management

Industry experts at Avantor describe a supply chain strategy to help drug manufacturers with multiple locations around the world manage and minimise the risk associated with the logistics of single-use systems while also ensuring regulatory compliance

Cleanroom validation: Quality of the product to the front

Cleanroom validation is a multifaceted project, so it is advantageous to have a dedicated project manager to lead, track, coordinate and schedule each step in a preplanned sequence. Ryan Burke, Analytical Lab Group, explains the process

Bioanalytical strategy: Authorities’ expectations to consider

Dr Markus Fido, analytical characterisation expert and VelaLabs co-founder, looks at the product lifecycle of biopharmaceuticals to describe the methods manufacturers should use to ensure required safety and quality under Directive 2001/83/EC

Classification vs monitoring: What is the difference?

Understanding cleanroom classification and monitoring is critical to production and compliance. To prevent confusion between these two definitions, Hasim Solmaz, Lighthouse Worldwide Solutions, describes common and different points

A to Z guide to protective garments

Understanding, assessing, validating and auditing the entire value chain of cleanroom garments is critical to making sure they are fit to play their part in the manufacturing process. Steve Marnach and Matheus Barbosa, DuPont, explain

Trending Articles

  1. Opinion: What is the future of robots in cleanroom maintenance and cleaning? Ryan McClymonds from i-team Global, explores key challenges of cleanroom cleaning and how these prompted the world’s first battery-powered cleanroom floor cleaning range
  2. Tips for particle concentration compliance under ISO 14644-1:2015 Apply these six steps to make your cleanroom fit for the new standard, says Hasim Solmaz, Lighthouse Worldwide Solutions
  3. 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
  4. 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
  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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