Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
May, Tue, 2023
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Apr, Wed, 2023
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for surface contamination. This best practice…
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for surface contamination. This best practice…
Mar, Thu, 2023
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Sep, Mon, 2022
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state…
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state…
Jul, Fri, 2021
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile compounding facilities. These facilities need…
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile compounding facilities. These facilities need…
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