news
Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
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QA/QC
video
On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
news
New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
whitepaper
Application note: Methods in protein/peptide discovery and development
This application notes offers method optimisation tips for purification, concentration and formulation of proteins and peptides.
news
Biological safety cabinet safest place for parenteral product compounding, says study
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
whitepaper
Whitepaper: Best practices in environmental monitoring
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
video
Video: tec5USA Anti-Counterfeit Solutions by Spectral Engines
All-in-one Drug Anti-Counterfeit Solution for improved pharma product security and brand protection, brought to big pharma companies via tec5USA.
news
Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
video
Video: Fast BET assay Setup – See it in Action
See how QC analysts can easily set up fully compliant 21-sample BET assays in 9 minutes with less than 30 pipetting steps.
video
Video: Automation of endotoxin assays
Want easy automation of BET assays and high throughput? Watch the video to see fast BET assay setup with centripetal microfluidic automation.
news
European Pharmacopoeia publishes new chapter on balances
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
whitepaper
Application note: TOC Reference Materials – Make vs. Buy?
Explore the cost comparisons, risk reduction, and increased support that arise when using Sievers Certified Reference TOC Standards.
whitepaper
Application note: USP <643> TOC limit changes
This application note addresses the TOC limit changes in USP for packaged water. The new limits account for varying container volumes.
article
Principal component analysis of Raman spectra for freeze-drying process monitoring
Optical spectral measurement tools are extremely useful both for in-line measurements in process analytical techniques (PATs) as well as for evaluating the composition of finished substances. Here, CPI’s Lukas Kuerten and Rachel Findlay demonstrate a valuable method for gaining useful information from spectral data.
news
FTIR, NIR and Raman – advantages and disadvantages for protein characterisation
Here, EPR summarises a review of some of the benefits and disadvantages for spectroscopic techniques used to characterise the structure of therapeutic proteins in solid dosage forms.
