Fundamentals of EBeam Sterilization

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  • เผยแพร่เมื่อ 29 ก.ย. 2023
  • From our partners at Sterigenics we bring you this webinar on Ebeam Sterilization:
    Since the 1950’s the irradiation of medical devices using electron beam (e-beam) sterilization has been a common practice. Decades later, as medical devices and packaging configurations have become more complex, so has the demand for higher power e-beam accelerators. This webinar will cover the fundamentals of e-beam sterilization and review the processing capabilities of today’s modern equipment. We will review comparisons of e-beam and photon-based sterilization modalities, covering topics specific to product qualification, transitions between modalities, and ideal products to consider for e-beam irradiation.
    About RCA
    Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:
    Life Sciences
    Pharmaceutical
    Biologic & Biotechnology
    Sterile compounding
    Medical device
    Lab Testing
    We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
    Founded in 2000
    Headquartered in Wisconsin (USA)
    Expertise backed by over 500 industry subject matter experts
    Acquired by Sotera Health in 2021
    About Sotera Health
    The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
    Sotera Health Company, along with its three best-in-class businesses - Sterigenics®, Nordion®, and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
    We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
    To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
    Commitment to Quality
    Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

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