Market Reports

An eco-friendly solution to microbial contamination

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

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: 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

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

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

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

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

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

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?

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

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

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: 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

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?

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

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. Harmonisation of Annex 1 and ISO 14644-1: A deeper look Alexander Fedotov from Invar explains that the harmonisation of standards seems to be a driving force for setting particle limits and why this may not always result in logical scientific decision making
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    Must cleanrooms always run at maximum airflow? Mona Åkerholm and Hannu Nurminen from Elomatic walk through how companies should be rethinking cleanroom ventilation in the age of sustainability and soaring energy costs
  3. EXCLUSIVE: The journey to create Staubli's new robot for pharmaceutical manufacturing Julien Lora from Staubli talks to Sophie Bullimore about the development of the company's new robotic pharmaceutical solution, discussing the complexities of its launch as well as the pharmaceutical landscape it is launching into
  4. 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
  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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