Market Reports

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

Sensors meet hydrogen peroxide applications

The proprietary sensor technology in Vaisala’s PEROXCAP and HPP272 probe is a game-changer in bio-decontamination with hydrogen peroxide. Piritta Maunu, explains the advantages of its use to validate the integrity of rooms, isolators, RABS&#8200;and transfer chambers

Interview: Colandis CEO Joachim Ludwig

From employee at Carl Zeiss to CEO of his own company, Joachim Ludwig has become an expert in cleanroom applications for technology industries. He believes unconventional solutions to client’s requests are key to a successful future in this market

Bye bye to biological indicators

For the last four decades, decontamination cycle performance validation has been based on placing biological indicators (BI) into the decontamination process. Phillip Godden, Protak Scientific CEO, explains why the use of enzymatic indicators (EI) is a solution to continuous monitoring of “fragile” hydrogen peroxide decontamination processes

Getting ahead of the regulatory curve for sterile compounded drugs

Kenneth Maxik, Director of Patient Safety and Compliance, CompleteRx, remarks on the sweeping changes to the USP in 2018 and the revisions likely to have the most significant consequences to clean environments

Easing energy consumption in cleanrooms

Monitoring energy use to benchmark yearly consumption in HVAC helps companies to meet today’s challenging regulations without compromising contamination control. Steve Wake, Director Validair UK, explains

Trending Articles

  1. Guardtech and Elis: Taking over a cleanroom laundry build mid-project Originally contracted to develop just the cleanroom, Joe Shackley from Guardtech talks about taking the cleanroom laundry build after the original Principal Contractor was unable to fulfil the requirements
  2. The importance of growth promotion testing Given the critical nature of microbiological quality tests which are employed to ensure that pharmaceutical products are safe for human use, it is in turn essential to undertake quality control (QC) tests to ensure that the culture media being used for these is fit for purpose and performs properly. Cherwell Laboratories' Steven Brimble explains
  3. Cleanroom tightness and room pressurisation: Discrepancy? A cascaded room-pressure regime has been considered for decades to prevent cross-contamination of different processes. But Harald Flechl from ISPE says today's tight cleanrooms must have leaks to ensure a room-pressure regulation - so why should we build tight cleanrooms?
  4. 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
  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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