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: Air
Isokinetic Sampling
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.
Contaminated Eye Drops and Effective Contamination Control
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.
ISO/TR 14644 TR 21
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.
