The primary method for sterilizing medical devices and combination products is gamma irradiation, which is also used for sterilizing pharmaceutical and biopharmaceutical drug products. However,
The preservation, promotion, and enhancement of patient life is inextricably linked to the quality and safety of compounded and manufactured drug products. This document provides
The United States Pharmacopeia published new 797 standards for pharmaceutical compounding – sterile preparation. Many of the new standards change/affect how 503a’s and 503b’s who
Before electron beam (E-Beam) | X-Ray irradiation can be used as a method of sterilization, a validation process must be done to establish the sterility
There are many proven methods to validate radiation doses for all compounded drugs and pharmaceutical drugs. Each uses product bioburden enumeration to quantify the concentration
The process of establishing radiation dose uniformity between the sterilization dose, or minimum dose, and the maximum dose deemed acceptable during the validation process is
The Pharmacy500 is awarded to 500 supply chain businesses and associations that have made a significant impact on dispensing pharmacies in the U.S. over the
• Extension – Scale with your business, scalable lot sizes • Duration – Same day to 48-hour turnaround, processing on your schedule 5 days a
