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  • Product Packaging Considerations for Gamma Processing
    Changes to product packaging that impact outer dimensions, weight, or product orientation, require that revisions be made to the processing specifications and handling instructions on file with a contact sterilization provider
  • Material Consideration Radiation Processing - Sterigenics
    • Residual mold stress present after molding and assembly of a component or product can promote molecular scissioning during irradiation • Highly oriented moldings, which are strong in the axis of orientation but are already very weak in the cross-flow axis, will become weaker after irradiation • High molecular weight polymers having
  • PPM-222 Sterilization of medical devices packaging
    A wide variety of sterilization methods are used in the medical industry, including electron beam (e-beam) irradiation, gamma irradiation, ethylene oxide (EtO), autoclave, and low-temperature hydrogen peroxide gas plasma Selecting the best sterilization for a medical device depends on many factors As a result, it is extremely
  • Gamma Radiation Sterilization - GMP SOP
    This document provides guidance for validation of gamma radiation sterilization processes used to sterilize active pharmaceutical ingredients (API), drug products, medical devices, and non-product items, such as, APA gowning articles, containers, and closures with direct or potential contact with sterile raw materials (RM), APIs, drug products,
  • Questions and Answers on the use of X-ray sterilisation processes for . . .
    In this regard, X-ray sterilisation techniques show penetration ability of photon energy comparable to gamma irradiation sterilisation techniques and could be considered a suitable alternative to substitute for gamma-sterilisation
  • WHAT’S NEW IN RADIATION STERILIZATION AND DISCUSSION ON GAMMA ELECTRON . . .
    CHANGES TO INDUSTRY APPROACH FOR STERILIZATION •Ethylene oxide o Considering lower EO gas concentrations o Considering more optimized overkill cycles o Considering BI bioburden or bioburden-based sterilization cycles •Industry effort to develop alternative technologies to gamma and EO
  • Risks of Using Sterilization by Gamma Radiation: The Other Side of the Coin
    Low dose of gamma radiation (12 5 kGy) induced vacuolar cytoplasmic changes in epidermal cells while fine elastic fibers were more radio-resistant and their damage was observed only after sterilization with standard dose of irradiation (25 kGy)
  • ISO 11137: An Introduction to Gamma Sterilization Validation
    Unsterilized or improperly sterilized devices pose a severe risk to patients and users Fortunately, there are a number of well-known methods for sterilizing medical devices This article, specifically, will cover gamma irradiation as a sterilization method and its attendant ISO standard, ISO 11137 WANT TO BECOME A MEDICAL DEVICE INSIDER?
  • The Hidden Challenges of Gamma Sterilization for Medical Devices
    Gamma sterilization remains a cornerstone for ensuring the sterility of medical devices, offering consistency, reliability, and deep penetration into complex designs However, its risks, such as material degradation and microorganism resistance, demand proactive measures from manufacturers
  • Gamma Irradiation in the Pharmaceutical Manufacturing . . . - PharmTech
    Because gamma irradiation produces ionization events, it can lead to unintended or undesirable effects Each product must be tested in its final form with irradiation before a final decision to sterilize is made A material's tolerance to gamma irradiation must be documented and its effects known





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