Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 2
In this article, Dr. Ross Caputo outlines the importance of trending and analyzing data from an environmental monitoring program in order to provide critical indicators about the state of control of the sterile compounding environment.
Environmental Monitoring & Why it Matters: Part 2
In this article, Dr. Ross Caputo outlines the importance of trending and analyzing data from an environmental monitoring program in order to provide critical indicators about the state of control of the sterile compounding environment.
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 1
Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. Sterility tests cannot reliably detect contamination in compounded sterile products
Environmental Monitoring & Why it Matters: Part 1
Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. Sterility tests cannot reliably detect contamination in compounded sterile products