Applications Testing packaging containers: vials, ampoules, cartridges, prefilled needles, infusion bags/bottles, BFS, PP bottles, etc. Filling materials: liquid or conductive products Testing accuracy: minimum 0.2um, conventional products 1um
Comply with 21CFR data traceability requirements and USP1207\CDE consistency evaluation technical requirements
Application Testing Packaging Containers: Vials, Ampoules, Prefilled Needles, Infusion Bags/Bottles, BFS, Cartridges, etc. Filling Materials: Freeze-dried, Powders, Solutions, etc. Test Standards: ASTM-F2338-09 (Vacuum Decay); ASTM F2095 (Pressure Decay)
Detection sensitivity: up to 0.01sccm (equivalent pore size about 1um)
It has permission management, audit log, and automatic data storage functions that meet the requirements of 21CFR Part11
Applications Testing packaging containers: vials, ampoules, infusion bags, food packaging, etc. Measurement technology: TD-LAS adjustable diode laser, near-infrared absorption spectroscopy Test accuracy: 0.1% O2
Features: Non-destructive testing, small headspace required, calibration-free, meets USP1207 General Principles for Pharmaceutical Packaging Integrity
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