whitepaper
Article: Water activity of oral solid dosage products using FMS
This article describes water activity determination of OSD using Frequency Modulation Spectroscopy, with a non-destructive headspace gas analyser.
List view / Grid view
QA/QC
news
EU’s Medical Device Regulation is now applicable
Europe’s Medical Device Regulation is now applicable to medicines with an integral device, devices containing an ancillary medicinal substance and several other products.
whitepaper
Article: Replacing blue dye ingress with gas ingress CCI testing
This article describes headspace gas ingress as a CCI test method, which is increasingly being implemented to replace blue dye.
webinar
Quality assurance and data integrity from an auditors’ viewpoint
21 May 2021 | By Thermo Fisher Scientific
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.
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.
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.
