Market Reports

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
The cleaning power of plasma

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

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

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

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

Trending Articles

  1. 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
  2. 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
  3. Cleanrooms: solving the mystery of recurring low level contamination Dr Laurie Smith reviews her research that identified bacteria on cleanroom garments to solve the mystery of recurring low-level contamination in a facility
  4. Contamination control in satellite production Satellite construction undergoes extraordinary changes as new technologies and increased demand alter their type and size. Susan Birks reports on future contamination control requirements following a visit to a cleanroom of Airbus UK
  5. Precision cleaning explained Cleaning to perfection is a sophisticated process and yet vital to product integrity. Dr Brent Ekstrand, VP of Science & Technology at Astro Pak, sheds lights on contaminants and the tests performed to measure them

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