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New guidance issued for 3D-printed Medical Device License applicants
Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices.
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Manufacturing
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It’s not just about the science: microbiological analysis
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…
whitepaper
Case Study: Using AdvantaSil™ High Pressure Unreinforced Silicone Tubing for bulk fluid transfer
The transfer of bulk liquids, such as media, buffer and intermediates, are critically important in biopharmaceutical production processes. This case study describes the performance of AdvantaSil High Pressure Unreinforced Silicone Tubing (APHP) used in a Monoclonal Antibody process for the transfer of buffers in purification.
news
Taking the difficulty out of API process filtration
Amazon Filters has selected the Making Pharmaceuticals Exhibition & Conference 2019 to showcase its latest filter housings and microfiltration filter cartridges, which are used in the manufacture of Active Pharmaceutical Ingredients (API) and are the essential components when creating pharmaceutical products.
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Sepha VisionScan: Non-destructive, deterministic blister leak testing down to 7µm
Introducing a smart alternative to traditional blue dye test methods. The Sepha VisionScan uses a non-destructive method to provide reliable, objective and deterministic results. The machine doesn’t require tooling, making it ideal for production lines running multiple products.
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European Pharmaceutical Review Issue 2 2019
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
whitepaper
Application note: Cleaning validation from HPLC to TOC: three factors to consider
This application note from SUEZ outlines the factors that companies should consider when choosing their cleaning validation procedure, highlighting the benefits of TOC analysis over HPLC.
whitepaper
Flyer: API commercialisation
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
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Biotechpharma to expand process development and GMP manufacturing capacity to 5,000 L
Biotechpharma UAB will expand its existing manufacturing facility by adding a new line of bioreactors
webinar
Don’t let difficult substances control your cleaning validation
18 April 2019 | By SUEZ
TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring...
news
Merck recognised with INTERPHEX Exhibitor Award for Best New Product
Merck wins award for first-of-its-kind, single-use tangential flow filtration capsule used in ADC and monoclonal antibody bioprocessing...
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Merck elevates its BioContinuum platform strategy to deliver ‘ContiGuous’ bioprocessing
Launch is taking place at the International Pharmaceutical Expo (INTERPHEX) in New York
whitepaper
Whitepaper: Cubis® II Pharma Compliant by Design
Sartorius' Cubis® II balance series offers customisable modularity to ensure compliance with FDA directive 21 CFR Part II and EU Annex 11. This whitepaper outlines details of the technical solutions that will enable companies to achieve full compliance.
news
Setting the standard for water quality measurement and control
A brief overview of how SWAN Analytical Instruments helps to ensure water quality with analysers to measure trace ozone and total organic carbon (TOC).
whitepaper
Application note: Conductivity bridge study – from benchtop metre and probe to automated Sievers M9
This application note discusses the desired future state for measuring conductivity of compendia water samples and how the Sievers M9 TOC Analyzer with Conductivity enables users to reach this state.
