USP 797 Updates
The most recent revision to USP 797 brings forth changes that touch various aspects of pharmaceutical practices. Here, we explore the USP Regulatory Standards Development Process.
Category: Microbial
Microbiological Air Monitoring: Navigating Choices in Cleanroom Contamination Control
This blog post discusses navigating choices in cleanroom viable air monitoring, offering fundamental insights to guide your approach.
Single-Use Microbial Impactor for Active Air Sampling
Here we will briefly explore the history, applications, and recent advancements in single-use impactors for active air microbial sampling, with a focus on a groundbreaking single-use alternative.
ATMP Sterility Testing
In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal moment in the industry. This blog provides a background in ATMP sterility testing and the FDA in relation to the paper linked below that outlines guidelines on good manufacturing practice specific to Advanced Therapy Medicinal Products.