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 something every industrial radiation entity must do—and must get right. To do so, a dose audit is necessary at specific frequencies, ensuring consistency. Samples are tested to show verification levels on medical devices at SAL 10-1 or 10-2 and doses usually less than 10kGy. The dose audit must be lower than the standard processing dose to certify sterility assurance. To get a more precise dose range, the guiding principles for irradiator processing and the product configuration may require fine-tuning and then be substantiated. Read more >
MediZap is the only contract terminal sterilizer by E-Beam | X-Ray irradiation built for compounders. Our 4 Pillar Service includes Advanced Sterilization, Packaging Solutions, Compliance, and Exclusive Partnerships. We offer 48-hour processing, dedicated capacity, group pricing, and a compounding center of excellence. USP 797 and cGMP guidelines start with terminal sterilization, and our technology is the most advanced solution, ensuring low-risk 10-6 SAL and delivers the safest drug products to hospitals, practitioners, and patients.
