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 assurance level. This process then sets the sterility standard for future testing of a product. The validation process guidelines on health care products per ISO 11137 have three sections: Requirements for development, validation, and routine control of a drug product. Establishing the sterilization dose. Guidance on dosimetric aspects. What follows is an overview of the standards established by industry regulations for E-Beam | X-Ray irradiation. 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.
