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Whitepaper: Why extractables and leachables matter
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
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Medical Devices
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Regulatory challenges and myths in pharmaceutical 3D printing
Although three-dimensional (3D) printing has been around for some time, many people still underestimate its capabilities. This article addresses the regulatory challenges faced by the pharmaceutical sector and aims to correct some of the most common myths surrounding the technology.
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Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
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Whitepaper: The necessity of E&L qualifications for lyophilised drug products
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
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Brochure: G-CON cleanroom POD
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
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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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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.
