Sterilization & Packaging
14 articles
Cleaning Validation for Reusable Surgical Instruments: Soil, Residue, and Worst Case
Build cleaning validation protocols for reusable surgical instruments, covering test soils, residue endpoints, worst-case devices, ST98 criteria, sampling, and reports.
ISO 17664 Reprocessing Validation for Reusable Medical Devices
Guide to ISO 17664 reprocessing validation for reusable devices, covering cleaning, disinfection, sterilization, worst-case families, IFU content, FDA expectations, and submission evidence.
Medical Device IFU Reprocessing Instructions: Validated, Audit-Ready Guide
Step-by-step guide to writing validated reprocessing instructions for reusable device IFUs, covering cleaning, sterilization, usability, warnings, and audits.
Washer-Disinfector Validation: ISO 15883, A0 and Routine Monitoring
Validate washer-disinfector equipment and cycles under ISO 15883, including IQ/OQ/PQ, A0 thermal disinfection, load configurations and routine monitoring.
ASTM D4169 Transportation Validation for Medical Device Packaging
Guide to ASTM D4169 packaging validation, including distribution cycles, assurance levels, drop, compression and vibration tests, ISO 11607 links, sample size, and acceptance criteria.
Endotoxin and Pyrogen Testing for Medical Devices: BET Guide
Guide to medical device endotoxin and pyrogen testing, including BET methods, rFC alternatives, ISO 11737-3, USP <85>/<161>, FDA guidance, and device limits.
Bioburden Testing for Medical Devices: Complete ISO 11737-1 Guide
Guide to bioburden testing under ISO 11737-1:2018, covering method validation, recovery efficiency, extraction, enumeration, dose setting, and routine monitoring for medical device sterilization.
Cleanroom Standards for Medical Devices: Complete ISO 14644 Guide
Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.
Hydrogen Peroxide Sterilization (ISO 22441): Complete VHP Guide for Medical Devices
Validate vaporized hydrogen peroxide sterilization under ISO 22441:2022, including FDA recognition, process parameters, material compatibility, validation protocols, and regulatory strategy.
ISO 11137 Radiation Sterilization: Gamma, E-Beam, and X-Ray Guide
Guide to ISO 11137 radiation sterilization for medical devices, covering gamma, e-beam, and X-ray methods, dose establishment, materials compatibility, validation, and dose audits.
ISO 17665 Steam Sterilization Guide for Medical Devices
Guide to ISO 17665 steam sterilization, covering moist heat principles, IQ/OQ/PQ validation, F0 lethality, biological indicators, cycle design, autoclave qualification, and monitoring.
Medical Device Packaging Validation: Complete Guide to ISO 11607 Compliance (2026)
Validate medical device packaging to ISO 11607, including sterile barriers, material qualification, aging studies, distribution simulation, seal testing, and shelf-life claims.
Medical Device Shelf Life and Stability Testing Guide
Plan shelf life and stability testing for medical devices, including ASTM F1980 accelerated aging, real-time studies, sterile barrier testing, packaging validation, and expiration dating.
Ethylene Oxide (EO) Sterilization for Medical Devices: The Complete Guide
A comprehensive guide to EO sterilization — process development, ISO 11135 validation, residuals testing, environmental compliance, and how it compares to alternative sterilization methods.