USP 797 published new proposed guidelines for comment. Many of the new standards change/affect the compounding industry. Medizap / SteriTek have read the USP 797 guidelines to develop a position. The goal is to share this position with you.

By being thought leaders, we hope to influence USP 797 guidelines while also building the advocacy and trust of the APC, compounding industry, and all stakeholders affected and defined by this Pharmacopeia regulatory body.

Medizap / SteriTek is uniquely positioned to bring a scientific perspective to the newly proposed guidelines and ensure understanding and use of ISO guidelines for all irradiation validation and ongoing testing since USP 797 omits detailed Irradiation standards. We believe that selecting the Irradiation sterilization modality defaults to ISO regulatory guidelines. Read More >