News & events

Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.  Benefits of growth promotion testing:  

James Zellner, Microbiologist and Technical Sales Representative What Growth Media is Appropriate for Specific Uses? There are dozens of different types of microbial growth media available to Microbiologists, developed for a wide variety of purposes.  The United States Pharmacopeia (USP) references many of these to demonstrate the quality of both compounded drug products and the control of compounding

Andrew Taylor, ARL Bio Pharma Microbiology Supervisor USP <795> Pharmaceutical Compounding – Nonsterile Preparations states compounders are responsible for minimizing patient harm resulting from multiple issues, including excessive microbial contamination in nonsterile drug products. The chapter directs compounders to USP <1163> for recommended quality control tests, including USP <61> Microbial Enumeration Tests and USP <62>

James Zellner, Technical Sales Identification of a contaminant in a sterile preparation is vital to determining the origin of the microorganism and its avenue of entry.  The organism’s identity, combined with environmental monitoring data, provides actionable information to improve a pharmacy’s processes and prevent future contamination. Organisms can enter a drug product through: The source

Andrew Taylor, Microbiology Supervisor Microbial identification is an important component of a quality assurance program; specifically as it relates to environmental monitoring (EM), raw material and final product bioburden assessment, and out-of-specification (OOS) investigations. Environmental Monitoring USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “a successful environmental control program includes an appropriate level of