ExtenDATE™ Sterility Testing System (6 Tests)
The ExtenDATE™ is a complete, USP<71>-compliant sterility-testing solution for Small-Volume Parenteral (SVP) Compounded Sterile Products (CSPs) that are not inhibitory and do not produce cloudiness or precipitates.** Used in accord with the comprehensive process setup and control, and the compounding instructions provided, this new product quickly and easily assures the USP<797>-compliant compounding of 40-200 mL CSP batches, confirmed by USP<71>-compliant sterility testing of these products. The instructions and guidelines allow the hospital and clinical pharmacy to safely and cost-effectively prepare complete SVP batches in-house, with the maximum expiration dating to extend the usability and availability of these products, without the need for any outside vendors. SteriMS™ and ThioMS™, the revolutionary new USP<71>-compliant products that comprise the ExtenDATE™ Sterility Testing System, are also available separately in packages of 12.
** In order to test small-volume CSPs containing penicillins or cephalosporins using USP<71> methods, an appropriate quantity of pre-assayed, sterile Beta-lactamase may be aseptically added to the sample piggy-back source container prior to obtaining the test sample in order to inactivate the antibiotic action, thus removing any antibiotic inhibition of the test. In this manner, the broadest range of small-volume CSPs possible may be assayed as appropriate to extend expiration dating.