ScanRDI® Rapid Sterility Test
A Faster Way to Comply
A sterile compound with a 30 day expiry will lose approximately half its shelf life due to the 14-day incubation period required for the USP <71> sterility test. ScanRDI® sterility test follows a validated methodology that produces results in as little as 1 business day, enabling you to provide your patients with medication that you feel safe about, while maintaining product shelf life.
The Limitation of USP <71>
In order to fully comply with USP <797>, a compounding pharmacy creating sterile preparations must develop its own formal quality assurance (QA) program.
The characteristics of a QA program require the consideration of environmental testing and preparation verification results, with the recommended testing method outlined by USP <71>.
14 Days of Incubation
Because the compendial method of testing takes 14 to 18 days to complete, it is extremely limiting in the compounding industry.
Decrease in Product Shelf Life
A sterile compound with a standard 30 day expiry will lose approximately half of its shelf life due to sterility testing.
This delay may discourage compounders from developing or adhering to a QA program, leaving them at risk of failing an FDA inspection.
Eagle has developed and patented a method that allows us to test your oil-based preparations using the ScanRDI® Sterility Test. Eagle President and CEO explains this breakthrough discovery in this video
Results In as Little as 1 Business Day
The ScanRDI Sterility Test Protocol is an FDA-accepted alternative to the official compendial sterility test method.
ScanRDI rapidly detects viable microbial cells down to one microorganism without the need for growth or cell multiplication
This removes the extended incubation period included in the USP <71> test method, so results are ready in just one day.
Now there is a faster way to comply with USP <797> and ensure your patients are receiving quality compounds. The ScanRDI fulfills the method suitability requirement as outlined in USP <1223>. A suitability test is performed on every unique drug formula sample submitted for ScanRDI testing. If the suitability of a compound does not pass this test, Eagle will inform the compounding pharmacist that it was incompatible with the ScanRDI method.
A Detailed Analysis
“Suitability of ScanRDI® as a Rapid Sterility Testing Method”
ScanRDI System Performance
A Ten Year Survey of ScanRDI System Performance Data as a Sterility Test Method for Pharmacy Compounded Preparations
Make the switch today, and get started with ScanRDI.
NOTES FOR SAMPLE SUBMISSION:
Sample Size – We recommend following the USP <71> guide for minimum sample requirements.
Method Suitability is recommended but not required.