The Limitations of USP <71>
In order to fully comply with USP regulations, a facility producing sterile product must develop a formal quality assurance (QA) program. One of the characteristics of a QA program includes routine testing of sterile preparations. However, the USP <71> sterility test method presents the following limitations:
14 DAYS OF INCUBATION
The compendial method of testing takes 14 to 18 days to complete, due to the incubation period required in the testing procedure.
DECREASED PATIENT USE TIME
As a result, a sterile compound with a standard 30-day expiry loses approximately half of its shelf life due to sterility testing.
A Faster Way To Comply
The ScanRDI® is a unique alternative technology that enables Eagle to deliver sterility testing results in 1 or 2 business days†, allowing sterile compounding facilities to release product faster than when utilizing the compendial USP <71> method. ScanRDI® has revolutionized rapid microbial detection and its combination of speed and sensitivity remains unrivaled to this day(a). Additionally, ScanRDI® fulfills the method suitability requirement as outlined in USP <1223>.
Results in 1 Business Day†
Now there is a faster way to comply with USP <797> and ensure your patients are receiving quality compounds. ScanRDI® is a non-growth-based technology sensitive enough to detect a single bacterial, yeast, or mold contaminant in a matter of hours. Even spores, stressed and fastidious organisms are detected in minutes, offering an extraordinarily rapid alternative to the traditional 14-day sterility test(a).
THE SCANRDI® IS AN ACCEPTED ALTERNATIVE TO THE OFFICIAL COMPENDIAL STERILITY TEST METHOD.**
DETECTS VIABLE MICROBIAL CELLS
SCANRDI® RAPIDLY DETECTS VIABLE MICROBIAL CELLS DOWN TO ONE MICROBIAL CELL WITHOUT THE NEED FOR GROWTH OR CELL MULTIPLICATION.
FORGOES THE EXTENDED INCUBATION PERIOD
THIS FORGOES THE EXTENDED INCUBATION PERIOD INCLUDED IN THE USP <71> TEST METHOD, SO RESULTS ARE READY IN 1 BUSINESS DAY.†
Now Serving Rapid Sterility Tests on Oils with ScanRDI®
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 Ross Caputo, Ph.D., explains this breakthrough discovery in this video.
Ready to Get Started?
Complete the form below to receive an initial consultation and discuss your operation’s specific needs.
* ScanRDI® is a registered trademark of Biomeriuex.
** Method currently not accepted in some states.
† Standard processing time is 2 business days. 1 business day turnaround time is available through our RUSH service. Please contact Eagle’s Client Care Team at 800.745.8916 for details and for up-to-date scheduling upon sample submission.
(a) Biomeriuex – ScanRDI® Rapid Microbial Detection – http://www.biomeriuex-usa.com
“I’m delighted to be doing business with Eagle”
Eagle has become an integral part of ensuring we deliver safe compounds and maintain the quality that allows us to have trust among pet owners and veterinarians. We utilize a triple-check system to test our compounded medications and rely on their superb service and expertise on a regular basis. The level of competence exhibited in the representatives I deal with gives me confidence as a pharmacist, and I’m delighted to be doing business with Eagle.
Danny Carrero, Best Pet, RX – New York, NY