Sterility testing of compounded sterile preparations is crucial to prevent patient harm from microbial contamination. USP 797 requires sterility testing for:
• Category 2 CSPs which are assigned a beyond use date (BUD) that requires sterility testing.
• All category 3 CSPs.
The Food and Drug Administration (FDA) requires 503B outsourcing facilities to perform sterility testing for all drugs reported to be sterile and/or non-pyrogenic.
Sterility testing must be performed according to USP 71 or a validated alternative method per USP 1223 that is non-inferior to USP 71. Method suitability must be demonstrated for each drug product with correct sample quantities tested according to the chapter. Sterility failures must be investigated and include the identification of contaminating microorganisms with documentation of the investigation or corrective action.
Alternative Sterility Testing Methods
Rapid Sterility testing allows for shortened incubation times compared to the traditional sterility test method. By reducing sterility test wait times, rapid sterility methods offer many supply chain advantages, faster product release schedules, and quick contamination investigations.
ARL now offers two alternative sterility test methods to help minimize the impact of USP 797 shorter beyond-use dates.
NEW – ScanRDI Solid Phase Cytometry Method: 0-2 Day Turnaround
This non-growth-based sterility test detects microbial contamination based on cytometry, which detects and quantifies microorganisms in as little as four hours. This ultra-rapid microbial detection method shortens investigation time by 1-2 weeks, leading to faster quality control improvements and process normalization. Speed up your distribution with ScanRDI and release drug products more quickly, lowering costs and reducing waste while eliminating bottlenecks. ORDER NOW >
Celsis ATP Bioluminescence Method: 6 Day Turnaround
This growth-based sterility test detects microbial contamination based on the presence of microbial Adenosine Triphosphate (ATP) in a sample. Results are objective and based on instrument analysis.
USP 1223 Method Validation
ARL’s rapid sterility validation protocol includes all required parameters listed in USP 1223, including specificity, limit of detection, repeatability, and equivalency. For the growth-based method, the recovery of stressed/injured microorganisms is also assessed, which is considered imperative as injured microorganisms are more representative of potential contaminants that may be present in preparations tested.
Traditional Sterility Testing Method
USP 71 Sterility Test Method: 14-18 Day Turnaround
This sterility method is a growth-based test method that requires at least 14 days of incubation time for microorganism growth to occur. ARL uses either a closed membrane filtration method (the preferred method) or a direct inoculation method for unfilterable sample types. At the conclusion of the test, if there is no evidence of growth, the drug product complies with the USP 71 test for sterility.
This post is related to:
Contamination Control: Quality Control, Lab Testing Services
