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Creating a COVID-19 Safety Toolkit for pharmaceutical businesses
Marta Kalas explains how to develop a COVID Safety Toolkit to ensure pharmaceutical businesses comply with changing regulations.
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Manufacturing
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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
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Case study: Challenges in manufacturing high value lyophilised oncology drugs
Key features of a custom-made freeze-drying integrated solution.
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COVID-19 vaccine supply chains: LBC’s Tom Swarbrick interviews EPR’s Victoria Rees
Junior Editor of European Pharmaceutical Review, Victoria Rees, speaks with LBC's Tom Swarbrick about the glass vials needed to contain the Oxford-AstraZeneca COVID-19 vaccine.
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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.
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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.
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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…
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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.
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Application note: Why extractables and leachables matter
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
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Whitepaper: Recombinant factor C: new Ph. Eur. Chapter 2.6.32
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
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Application Notes & Whitepapers 2020
Industry experts share their latest research and developments in pharma.
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Whitepaper: Combining rapid and EP bioburden testing
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
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Innovative filtration technologies to shoulder responsibility for pharmaceuticals
Akshita Pacholi outlines why the filtration market is so important to the pharmaceutical industry and discusses its predicted growth in the near future.
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Whitepaper: SARS-CoV-2 vaccines and biosafety
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
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Whitepaper: Analyte binding to syringe filters
Validation of syringe filters for QC testing: The parameters that influence analyte binding to filters.
