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 – Non-sterile 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>

FDA has identified the following list of drugs for the purpose of the temporary enforcement policies described in 503B guidance and 503A guidance during the COVID-19 public health emergency.  503B guidance establishes revised cGMP standards and allows outsourcing facilities to compound and distribute drugs needed to treat COVID-19 patients that hospitals cannot obtain from an FDA drug manufacturer due to

Andrew Taylor, Microbiology Lab Supervisor Celsis rapid sterility testing is an alternative test method to USP Chapter <71>, which allows for shortened incubation times compared to the traditional sterility testing method. Where USP <71> requires between 14 and 18 days of incubation before a final test result, a Celsis rapid sterility test result can be

Kathy Heatherly, MSFS, Technical Sales  As a compounder, protecting yourself and your staff from exposure to hazardous drugs should be important both from a safety and monetary perspective.  USP <800> applies to sterile and non-sterile compounding pharmacies and anywhere that hazardous drugs are received, stored, or administered.   It is also designed to prevent compounders from