Valiteq Aspectic Technique Verification System 1-800-433-7698

The Challenge

The new edition of USP <797> specifies compendial incubation for all Media-fill verification preparations, and the agar plates used to verify an operative's ability to both don, and validate sterile gloves without contamination. As a mandatory USP Standard, this is now the Law.

These new USP requirements are burdensome for pharmacy compounding facilities, in part, because these facilities do not traditionally have the SOP's, training, procedures, or equipment required for such exercises. Also, many do not feel they have the time or expertise to efficiently validate and document any such new, mandatory processes.

Any additional cause for reluctance to completely take on these new operations is, simply, the very last thing a pharmacy sterile compounding facility wants anywhere on its premises is any promoted, actively-growing microbial culture, which may easily result from these intensified testing procedures.

The Solution

The Valiteq/Lab Safety Corporation Laboratory has decades of validated experience with growth-promotion testing, and the incubation and containment procedures necessary to safely develop, enumerate, and dispose of pharmacy bacterial cultures arising from such testing. Our testing products and the development and reporting of such cultures represents a safe and complete cycle.

Over many years, we have developed these necessary functions for the IV compounding pharmacy. In addition, our systems are in place to assure and document the complete management of these demanding procedures.