Category: Microbial

Newspharmaceuticals life sciences

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.

Newssettle plates environmental monitoring microbiological air monitoring

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.

NewsMicrobial air sampler environmental monitoring biocapt single use sterility assurance

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.

NewsStem Cell Therapy Sterility Assurance Guidelines on Good Manufacturing Practice in Advanced Therapy Medicinal Products

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.

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