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SCANRDI® Rapid Microbial Method

THE WORLD’S FASTEST STERILITY TEST

A Faster Way to Comply

The SCANRDI® is a unique technology that enables Eagle to deliver sterility test results in 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).

The Limitation of USP <71>

In order to fully comply with USP <797>, a compounding facility producing sterile product must develop a formal quality assurance (QA) program.

The characteristics of a QA program include 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.

Decrease in Product Shelf Life

As a result, a sterile compound with a standard 30-day expiry loses approximately half of its shelf life due to sterility testing.

Breaking News!

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

The SCANRDI® Solution

Results in as little as 1 business day

Now there is a faster way to comply with USP <797> and ensure your patients are receiving quality compounds. SCANRDI® is 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 traditional 14-day sterility testing(a).

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 to ensure compatibility.

The ScanRDI® is 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 as little as 1 day, allowing us to deliver your test results within 2 business days.

Read 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

Why Wait Any Longer?

Join hundreds of facilities that have made the switch to SCANRDI®. Begin today to take advantage of this time-saving technology. Visit the link below to register. An Eagle representative will be in touch with you and get you started and/or answer any additional questions you may have.

 

SAMPLE SUBMISSION REQUIREMENTS

Sample Size: We recommend following the USP <71> guide for minimum sample requirements.

A Method Suitability is required on file to begin testing


SCANRDI® Registration / Interest Form


Standard processing time is 2 business days. business day turnaround time is available through our RUSH service. Please call Eagle customer care for up-to-date scheduling upon sample submission.

(a) Biomeriuex – ScanRDI Rapid Microbial Detection – http://www.biomeriuex-usa.com