Filter:
This paper discusses the goal to minimize microplastics in aquatic systems and validating the results. The authors of this paper propose a new approach of measurement and filtration that has the opportunity to reduce the microplastics that end up in our water. This alternative method would allow manufacturers to measure particles in treated textile water continuously for particles that are as small as 2.0 microns.
Introduction to Viable Air Sampling: Viable Environmental Monitoring Regulations related to viable air sampling play a pivotal role in shaping contamination control strategies in pharmaceutical manufacturing. The dynamic interplay of these regulations, both direct and indirect, is crucial for ensuring the safety and efficacy of drug products. With the advent of modern manufacturing concepts and the evolution of industry standards, the adoption of viable air monitoring becomes imperative to align with the latest regulatory trends.
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.
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.
This blog aims to discuss the science behind these differences, addressing concerns and shedding light on the characteristics of non-volumetric particle counters.
This blog post discusses navigating choices in cleanroom viable air monitoring, offering fundamental insights to guide your approach.
The newly published ISO/TR 14644 part 21 provides clarification on the application of sound airborne particle sampling techniques in support of ISO 14644-1:2015 for classification of cleanrooms and clean zones, and ISO 14644-2:2015 for airborne particle monitoring, to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
Once again, the specter of contaminated eye drops reaching patients has made headlines, according to the FDA, federal investigators found harmful bacteria and “insanitary conditions” at a factory where several eye drop products are made. The agency said it advised the manufacturer to recall the products.
In the highly regulated and risk-sensitive world of pharmaceutical manufacturing, adherence to stringent compliance measures is paramount. To achieve this, pharmaceutical companies use controlled environments, particularly cleanrooms, where the risk of variability and particle contamination is minimized. Here we’ll delve into the significance of cleanrooms and explore a key contamination management technique employed within them—Isokinetic Sampling and unidirectional airflow.
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.
