
SHINVA · Injectables
Laser Headspace Leak Aperture Calibration System
SHINVA laser headspace leak aperture calibration system for seal integrity testing of vials, ampoules and positive control samples with calibrated leak apertures. It employs an intelligent pressure control system to create a precise differential across the sample wall and uses laser absorption spectroscopy to detect internal pressure with ultra-high precision. The multi-physics leak model (critical/viscous flow coupling algorithm) enables measurement of micro-leak apertures and seal integrity in a non-invasive, non-destructive and user-friendly manner. Split design: the test chamber accommodates various sample specifications.
Key specifications
- Technology: laser absorption spectroscopy for internal pressure measurement
- Principle: intelligent differential pressure control across the sample wall
- Algorithm: multi-physics leak model (critical/viscous flow coupling)
- Operation: non-invasive and non-destructive
- Purging: no nitrogen purging required
- Measurement: direct headspace pressure change measurement in vials and samples
- Precision: ultra-high precision detection of micro-leak apertures
- Analysis: intuitive visualization and analysis of measurement data
- Design: split, with test chamber adaptable to various sample specifications
- Application: calibration of positive control sample apertures and seal integrity testing
Applications
- Pharmaceutical industry
- Integrity testing of vials and ampoules
- Calibration of positive control samples
- Seal quality control of packages
- Aseptic process validation
- Quality control laboratories