How to Test Particle Transportation in Tubing for Particle Counters
Archives: Papers
USP 1116 and its Implications for Measuring Microbial Recovery Rates
Mobile Monitoring Benefits for Molecular Contamination Sources
Decreasing the time to detect, contain and mitigate very low levels of Airborne Contamination (AMC) is becoming more critical for high tech manufacturers. Costs associated with AMC-related quality issues and yield losses are well understood, and adequate reduction of AMC is critical for clean manufacturers to stay competitve. A mobile AMC monitoring system speeds molecular contamination detection, localization and troubleshooting of sources. Learn more…
USP 1223 and EP 5.1.6- Validation of Alternative Microbiological Methods Overview
USP 1223 Validation of Alternative Microbiological Methods
USP 1223 Validation of Alternative Microbiological Methods and EP Chapter 5.1.6 Alternative Methods for Control of Microbiological Quality provide guidance on the selection and implementation of assay methodologies to serve as alternatives to compendial microbiological methods. The documents describe important steps that should be taken to evaluate candidate alternative methods, to select the analytical technology and ultimately to qualify the method with actual product. These steps include, but are not limited to:
Identification of a potentially suitable alternative methodology
Demonstration that the method is equivalent and applicable as a replacement for a standard compendial method
Development of user specifications for equipment selection
Qualification of the method in the laboratory