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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.
Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.
New study suggests that Tryptone Soya Agar (TSA) settle plate desiccation during exposure can reduce recovery of airborne microbes.
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
The expression of hydrophilins enables Acinetobacter baumannii to survive without water on hospital surfaces, providing a target for future elimination efforts and a pathway for biologic drug preservation.
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
