whitepaper
Article: Evaluating CCI of sterile vials using gas ingress
The article describes how CCI can be determined using Headspace gas ingress as a CCI test.
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QA/QC
whitepaper
News: Endotoxin automation is achieved with microfluidics for simple, compliant BET
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
whitepaper
Case study: New trends: reducing GWP impact on GMP freeze drying processes
How to turn an older refrigeration system in an existing freeze-dryer into a new environmentally friendly cooling system.
whitepaper
Article: Effects of deep cold storage at -80°C on CCI
This article describes the effects of deep cold storage on the container closure integrity of sterile product vials.
![Vials of heparin filling the screen [Credit: JLMcAnally / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin2-300x278.jpg)
![Vials of heparin filling the screen [Credit: JLMcAnally / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin2.jpg)
news
Novel spectroscopy technique could improve safety and quality of heparin
Using time of flight secondary ion mass spectrometry (ToF-SIMS) enabled the detection of nanoscale quantities of glycosaminoglycan (GAG) contaminants in heparin.
news
FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
news
European Pharmacopoeia adopts revised Raman spectroscopy chapter
The revised Raman Spectroscopy chapter (2.2.48) will be released in October, with updates focusing on enhancing the reliability of the results.
video
Short talk: How EN 17141 impacts active air sampler validation
This 11 minutes tutorial highlights the implications of the new EN 17141 for active air sampling compared to the previous standard ISO 14698.
whitepaper
Whitepaper: Progress in LC-MS-based metabolomics techniques
Get updated on recent advances in metabolomics analysis by mass spectrometry (MS) with this introduction to approaches and technologies.
whitepaper
Whitepaper: Analytical testing considerations for ATMPs
This whitepaper discusses the analytical testing considerations for complex biological materials in ATMPs.
whitepaper
Whitepaper: Neutralisers of disinfectants in culture media
A study investigating the efficiency of disinfectant-neutralising agents added to the culture media of contact plates and swabs for surface monitoring.
whitepaper
Web portal: Check your elemental impurity according to ICH Q3D guidelines
Request your Proficiency Testing (PT) samples to ensure your elemental impurity analysis is compliant with ICH Q3D guideline or any other ICP analysis.
news
Global mass spectrometry market to value $7.3 billion by 2028
With roughly a fifth of the mass spectrometry market made up by pharma and biotech, growing R&D investment and technological breakthroughs in mass spectrometers will contribute to market growth.
news
Cell-based seasonal influenza vaccine safe and effective in children
Phase III data shows Seqirus’ cell-based quadrivalent seasonal influenza vaccine was as effective and safe as an equivalent FDA-approved egg-based vaccine in paediatric patients.
news
ISPE announces its manufacturing Facility of the Year Awards winners
The awardees, including Takeda, Janssen and Gilead, are recognised for their state-of-the-art facility design, construction and operation projects.
