whitepaper
Whitepaper: Turbocharging Raman measurements
This whitepaper describes the proprietary HyperFlux™ optical spectrometer designs developed by Tornado Spectral Systems.
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QA/QC
news
EMA receives authorisation application for AstraZeneca COVID-19 vaccine
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
news
FDA monitoring impact of SARS-CoV-2 mutations
The FDA has alerted clinical laboratory staff and healthcare providers that it is monitoring the potential impact of SARS-CoV-2 mutations, including the UK variant.
news
Rapid microbiology testing market set to be worth over $6 billion in 2026
Rising at a CAGR of 8.2 percent, the rapid microbiology testing market is predicted to grow over the next five years.
whitepaper
Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
video
On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
news
Microbial surface recovery superior for vinyl than stainless steel
Researchers have shown that microbial surface recovery using contact plates was superior on vinyl than stainless steel.
whitepaper
Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
news
Concerns raised over India’s approval of COVID-19 vaccine with incomplete data
The All India Drug Action Network has said it is "shocked" India has given approval to Covaxin, a COVID-19 vaccine with a lack of peer reviewed safety and efficacy data.
article
Pharmaceutical bottle packaging – the quest for zero defects and data integrity
This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
article
Innovations in analytical science: development of rapid, high-throughput glycoanalytics for biopharmaceuticals
Researchers have developed a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. In this article, Victoria Smith, Lewis Wharram and Stuart Jamieson discuss their innovative approach and the implications for safety and potency assurance in biopharmaceuticals.
article
Life sciences flow metrology challenges
To realise quality, yield and cost benefits, there is a clear need to develop expertise and capability in the flow measurement and characterisation of pharmaceutical powder and fluid flows within continuous manufacturing processes. Dr Tracy Brown from the TÜV SÜD National Engineering Laboratory in the UK has investigated potential flow…
article
Recent improvements in deep ultra-violet fluorescence devices for cleaning verification
Since their debut, the range of applications for which deep ultra-violet (DUV) handheld devices are used in the pharmaceutical setting continues to grow. For pharmaceutical or biopharmaceutical cleaning verification, there is a requirement for a versatile and adaptive analytical and imaging device to demonstrate and document cleaning cycles. Here, Krishnakumar…
whitepaper
Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
article
Where now with quality by design?
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
