All Drug-device combination products articles – Page 2
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Articleebook: A practical guide to single-use filtration in biopharma
This ebook explains how single-use filtration can support safer, more efficient biopharmaceutical production. Discover more on different filtration stages and unveil key characterisations, like pore size and membrane material, empowering tailored selection to specific biomolecules and processes.
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Whitepaper
Solution brief: Environmental monitoring software
Monitoring microbial contamination levels at various stages requires focused, independent software with extended controls over microbial management. Digital monitoring of contaminants and their sources helps understand microbial behavior and trends. Thus, a reinforced, data- driven environmental monitoring mechanism is the key to maintaining controlled lab spaces for microbial trend analysis. ...
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WhitepaperWhitepaper: Complete Automation System for Endotoxin Testing
Automating a Laboratory’s BET workstream using Lonza’s PyroTec® PRO Robotic Solution, WinKQCL® Software, and MODA® Software.
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NewsPreventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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WhitepaperApplication Note: Automated Set-Up of the PyroGene® rFC Assay
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.
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NewsMedical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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Webinar
Mastering Pharma 4.0 validation challenges with technology
In this webinar Kneat Solutions’ Director of Consulting, Marcus Ryan, discusses the best way forward in the evolving world of Pharma 4.0™, revealing how companies can overcome validation complexities with technology.
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NewsRevised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
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Webinar
Applying ISO/TR 14644-21 - Airborne particle sampling techniques
Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.
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Article
Sustainability in BET from your endotoxin experts
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for nearly 50 years.
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VideoVideo: Unveiling the science behind NGS
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and ...
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NewsSurvey reports on falsification of medical devices
Falsification of medical devices exists in Council of Europe member states, but there are few investigations and prosecutions, a new survey finds.
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VideoVideo: Ami Polymer: Setting new bioprocessing standard
Our dedication to quality and prompt service has earned us several awards. You can trust us for top-notch service and reliability.
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NewsGuidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
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Whitepaper
Technical document: Introducing: Ami Polymer's Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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WhitepaperApplication note: Chemical characterisation & databasing at medtronic
Medtronic has created a data-handling workflow for chemical characterisation & database curation using MS Structure ID Suite.
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WhitepaperWhitepaper: EPIQ – Solution Brief
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
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Video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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VideoVideo: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Whitepaper
Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
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