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 a rigorous examination of the fundamental importance of terminal sterilization techniques, specifically focusing on ensuring the utmost safety and efficacy of sterile drug products.
Contained within are comprehensive analyses of key terminal sterilization methods, emphasizing radiation-based modalities such as Electron Beam (E-Beam), X-Ray, and Gamma radiation. While there are multiple terminal sterilization alternatives available (e.g. steam/dry heat), the scope of this discussion is strictly limited to irradiative terminal sterilization.
The pharmaceutical compounding and manufacturing industry is a complex, mature and ever-growing industry sector that persistently evolves to meet the regulatory requirements of the state pharmacy boards, FDA, USP, cGMP, and ISO (as applicable as based on 503A or 503B status). With rising demands of the burgeoning aging global demographic, as well as advancements in custom genetics sequencing there is a paramount need for continuous advancement in terminal sterilization capacities and a diverse portfolio of rigorously validated and regulatory-sanctioned methodologies. A single method, however sophisticated, cannot be universally implemented. 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.
