Technical bulletin: An updated approach to E&L testing per ISO 10993-18:2020
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
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Whitepapers & App Notes
Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
Application note: Software that makes data integrity compliance visible
Read this application note to discover the software that makes data integrity compliance visible: Shimadzu LabSolutions database (DB) or client/server software (CS).
Application note: From our platforms to your pen injector
Nemera offers four product platforms for pen development and manufacturing. These include reusable and disposable devices which are designed for various therapies to meet key users’ needs.
Application note: The Monocyte Activation Assay: The benefits of an animal-free test to show pyrogen-free pharmaceutical products
Fever is something that most of us have experienced. However, when we use medicines or medical devices, we expect them to improve our health – not to cause a fever.
Infographic: Simplified bacterial endotoxin testing
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
Brochure: Welcome to bioprocessing – pathways for pioneers
The journey from large molecule to approved biotherapeutic is long, costly, complex and fraught with risk – yet rewards for success are substantial.
Application note: Stability of protein formulations and their importance
The Crystalline offers the possibility to quickly obtain data on the stability of protein formulations by making use of the real time digital camera.
Article: Improved drug delivery with precision particle fabrication
Improved drug delivery with precision particle fabrication-enabling precise control over particle structure.
Infographic: How different endotoxin testing platforms work
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
Brochure: Crystalline seeing is believing
Access crystallisation and formulation information at ml scale with the Crystalline series.
Application note: Resilient plastics in the Cold Chain
Pictorial that explains how Aramus TM single-layer fluoropolymer bag can withstand gamma irradiation and cold-chain temperatures down to -196°C.
Whitepaper: Expanding solutions for challenging APIs
Expanding solutions for challenging APIs through the coacervation process.
Technical bulletin: Nitrosamines: Questioning the current analytical approach
We look at the challenges posed in regards to nitrosamine testing methodologies and the way in which to move forward to ensure safer drug products.
Article: Water activity of oral solid dosage products using FMS
This article describes water activity determination of OSD using Frequency Modulation Spectroscopy, with a non-destructive headspace gas analyser.
