T/CAMDI 009.2-2020 Cleanliness of Primary Packaging of Sterile Medical Devices Part 2: Particle Contamination Test Method Liquid Elution Method (English Version)
This document describes the test method for particulate contamination of primary packaging of sterile medical devices: the liquid elution method. This document is applicable to the initial packaging of sterile medical devices such as blister boxes and containers with irregular surfaces.
T/CAMDI 009.2-2020 history
2020T/CAMDI 009.2-2020 Cleanliness of Primary Packaging of Sterile Medical Devices Part 2: Particle Contamination Test Method Liquid Elution Method