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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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Medical Devices
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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…
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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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Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
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Whitepaper: BPOG extractables data in single-use systems adoption
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
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Fact sheet: TOC monitoring efficiency quiz
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
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FDA publishes list of essential medicines and medical countermeasures
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
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Novel non-opioid postsurgical pain implant launched
Innocoll Holdings Limited has announced the commercial launch of the XARACOLL® (bupivacaine HCI) implant, a non-opioid treatment for acute post-surgical pain for up to 24 hours in adults following open inguinal hernia repair.
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News: Microbial solutions product portfolio updates
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
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On-demand webinar: What you need to know about USP <1085>
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
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UK set to produce 70 percent of PPE required domestically by December
Due to the demand caused by the COVID-19 pandemic, the UK government has said British manufacturers will produce the majority of PPE by the end of the year.
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Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
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Artificial pancreas for type 1 diabetes control given nod by FDA
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
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The trials and tribulations of the medical devices and IVD regulations
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
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Intraoperative radiotherapy as effective as external beam radiotherapy, finds study
Researchers reveal that for early breast cancer a single dose of targeted intraoperative radiotherapy (TARGIT-IORT) is as effective at preventing breast cancer recurrence as the standard of care.
