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What Is Sterility Assurance Level (SAL) in E-Beam Sterilization and Why Does It Matter?
Posted on November 4, 2025By LydiaSterility assurance level defines the probability of a single viable microorganism remaining on a product after e-beam sterilization. The following table summarizes…
New Requirements for E-Beam Sterilization Validation under the EU Medical Device Regulation
Posted on November 4, 2025By LydiaThe EU Medical Device Regulation brings stricter controls to e-beam sterilization validation. ISO 11137 now plays a central role in…
Step-by-Step Guide to FDA 510(k) Clearance for Electron Beam Sterilization Medical Devices
Posted on November 4, 2025By LydiaManufacturers seeking FDA 510(k) clearance for electron beam sterilization medical devices must understand both the sterilization process and regulatory standards.…The Role of ISO 13485 in Maintaining Traceability and Control in E-Beam Sterilization
Posted on November 3, 2025By LydiaISO 13485 sets the foundation for traceability and control in e-beam sterilization, directly supporting medical device safety. This standard establishes a…
Improving Thermal and Chemical Resistance of O-Rings through E-Beam Crosslinking
Posted on November 3, 2025By LydiaE-beam crosslinking creates a stronger polymer network inside O-rings, which dramatically increases their thermal and chemical resistance. Industries like automotive,…How Gel Content Measurement Validates the Efficiency of Electron Beam Crosslinking?
Posted on November 3, 2025By LydiaValidating electron beam crosslinking stands as a critical step for ensuring reliable material performance in various industries. Gel content measurement…
How ISO 11137-2 Defines Dose Setting for E-Beam Sterilization?
Posted on November 1, 2025By LydiaISO 11137-2 serves as the key standard for setting and validating the sterilization dose in e-beam sterilization. The standard guides…
A Guide to ISO 11137-1 Compliance in Electron Beam Sterilization of Health Care Products
Posted on November 1, 2025By LydiaManufacturers can achieve ISO 11137 compliance in electron beam sterilization by focusing on process validation, establishing the correct dose using…
Understanding Fire Safety Requirements for Electron Beam Facility
Posted on November 1, 2025By LydiaFire safety in an electron beam facility demands strict attention to both regulatory rules and practical procedures. Operators must identify…
How Radiation Surveys Confirm Shielding Effectiveness in E-Beam Accelerator?
Posted on October 31, 2025By LydiaRadiation surveys in e-beam accelerator allow teams to directly measure how well shielding protects people and equipment. Detecting potential leaks…
Enhancing Operator Safety in Electron Beam Machines with Beam-On Warning Systems
Posted on October 31, 2025By LydiaKey Takeaways Risks in Electron Beam Machines Operator Hazards and Exposure Operators working with electron beam irradiation equipment face several…How Access Control Systems Enhance Safety in Electron Beam Machine?
Posted on October 31, 2025By LydiaOperators rely on access control systems to safeguard environments of electron beam machine. Interlock systems and sensors detect abnormal conditions…
Radiation Monitoring with Area and Personal Dosimeters in E Beam Processing
Posted on October 30, 2025By LydiaArea and personal dosimeters play essential roles in radiation monitoring during e beam processing. These devices work together to promote…
How “Man-in-the-Maze” Detection Systems Safeguard Workers in E Beam Sterilization Equipment?
Posted on October 30, 2025By Lydia"Man-in-the-Maze" detection systems shield workers from dangerous exposure by monitoring entry points and movement within e beam sterilization equipment. These…
How the Emergency Stop Button Protects Operators in Electron Beam Systems?
Posted on October 30, 2025By LydiaThe e-stop button acts as a vital safety device in electron beam systems. In emergency situations, this button gives operators…
