Learn how Mibelle Group improved their process control strategies using the 7000RMS analyser in parallel with validated plate counts.
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This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
Using a proprietary Stratµm TM technology, we have created 50 µm capsules with an aqueous core and thin PLA shell.
This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
Enhance your early stage solid state screening with the CrystalBreeder bench-top system.
Parvulet™ Technology is a patented oral dosage form capable of being dispensed to patients in tablet or powders, and converted into a semi-solid with water.
As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.
Learn here how to identify polymorphic transformation by using Raman and the Crystalline instrument.
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
Read this application note to discover the software that makes data integrity compliance visible: Shimadzu LabSolutions database (DB) or client/server software (CS).
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.
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.
The journey from large molecule to approved biotherapeutic is long, costly, complex and fraught with risk – yet rewards for success are substantial.