Market Reports

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

The cleaning power of plasma

The biggest issue in cleanrooms is particles landing on surfaces. Mike Hopkins, Impedans CEO, explains how the electric charge in plasma can be used to remove or reduce particles and even eliminate biological contamination on surfaces and equipment

Testing preservatives with PET

Tasmin Stock, Wickham Laboratories, explains the preservative efficacy test (PET), the specific challenges in preventing microbial growth and how partnering with experienced laboratories allows companies to comply with international regulations

The Legiolert protocol

A seven-year R&D programme has led to Legiolert, a new liquid culture testing technology that provides a faster method for detecting and quantifying <i>Legionella pneumophila</i> in water samples. Andrew Headland, Senior Business Manager for the IDEXX Water Division, EMEA, explains the method

Raising the bar for continuous environmental monitoring

Environmental monitoring (EM) is considered critical to all aseptic manufacturing environments where the sterility of the final product is paramount to quality and safety. However, the recently published draft of the new EU GMP Annex 1 now goes even further. Andy Whittard, Cherwell Laboratories, explains

Does your cleaning have the wettability factor?

Precision cleaning of printed circuit boards (PCBs) is required to meet stringent performance criteria. Mike Jones, VP MicroCare Corp, explains the “wetting Index” and how to determine the score of a fluid to measure its ability to clean complex shapes

Real-time particle fallout monitoring: Challenges and solutions

A patent-pending method based on CMOS sensor technology is set to revolutionise the monitoring of particle fallout in clean environments. Andrew Holland, XCAM, explains

Trending Articles

  1. 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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    Annex 1 and “first air”: What is it and how is it used? First Air as a concept is a major update in the new Annex 1 to continue global harmonisation of regulatory standards, but what is it and how is it used in the new document to improve clarity and compliance? Josh Russell, VP of Sales and Marketing at AST discusses
  3. Air filtration: Advantages of PTFE materials Air filter media built with PTFE, the synthetic fluoropolymer of tetrafluoroethylene, has many advantages when it comes to air filtration in cleanrooms and PPE. Robrecht Hendrikx, Market Manager for venting and filtration at Japanese manufacturer Nitto, explains
  4. 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
  5. 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

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