Whitepaper: Maintain product integrity in biologic clinical studies
Cold chain shipping challenges & root causes of common reference product sourcing problems.
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Cold chain shipping challenges & root causes of common reference product sourcing problems.
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
Study reveals that different Bacillus strains sporulate better in different media and conditions, establishing optimal parameters to produce spores for disinfectant efficacy studies.
Here, EPR summarises Tim Sandle's review of different methods for transferring items into aseptic areas, including decontamination chambers and pass-through hatches.
Here EPR summarises the salient points of a case study, presenting a strategy for identifying worst-case sampling locations on equipment for cleaning validation.
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
Read about bioMérieux's new system, 3P® ENTERPRISE - an end-to-end solution that fully digitalises and automates the EM process.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.
PCI’s Tim Roberts discusses key factors when outsourcing the clinical and commercial supply of biologics, and what makes a strong CDMO partnership.
Find out how a pharma company maintained product quality and reduced plate counts by 25 percent using a rapid microbial monitoring analyser – the 7000RMS.
Personal protective equipment (PPE) is a critical aspect of environmental and contamination control for compounding facilities, here we look at strategies to overcome PPE shortages.
According to a recent paper, by specifying equipment surface roughness as well as finish, pharmaceutical manufacturers can limit microbial attachment.
Here, EPR explores the application of Fourier Transform Infrared spectroscopy (FTIR) in pharmaceutical cleaning verification.