HGA Vial Inspection System (HGA-CCIT)

HGA-CCIT

Applications:

1) Container Closure Integrity Testing(CCIT) and Equivalent Leak Aperture Testing

2) Ultra-small equivalent leak aperture detection (minimum 0.1μm)

3) Detection of Packaging system lifecycle

Suitable for product R&D, sampling inspection, supervision, packaging material selection, positive sample preparation/pore size calibration, etc.

Description

HGA-CCIT integrates CO₂ Tracer Gas Preconditioning Unit and HGA-gas Inspection Platform. The system enables fast, high-precision non-destructive testing for CCIT and equivalent leak aperture of vials and ampoules, ensuring product quality throughout the full-lifecycle.

Parameters

Product Performance	Functional Parameters
Product Functions	Container Closure Integrity Testing(CCIT) and Equivalent Leak Aperture Testing Ultra-small equivalent leak aperture detection (minimum 0.1μm)
Applicable Vials	Compatible with 2R ~ 100R vials(Customizable)
Test Range (Equivalent Leak Aperture)	Standard aperture: ≥1μm Ultra-small aperture: 0.1~1μm (customized, compatible with standard apertures)
Detection Limit (Equivalent Leak Aperture)	0.1μm
Test Accuracy	0.1μm (specific accuracy depends on pretreatment time and headspace volume)
Test Time (Per Batch)	Standard aperture: 0.5~5min (Related to headspace volume) Ultra-small aperture: 2~30min (Related to headspace volume)
Permeation Pressure	1.5~2.5atm (absolute pressure)
Cavity Volume	3~4L (customizable)
Operating Environment	Temperature 15℃~35℃; Humidity 0~90%
Power Supply	220V AC，50/60Hz

Advantages

Compatible with 2R ~ 100R vials (Customizable);
Non-destructive testing, batch full inspection, single testing of multiple samples;
Container Closure Integrity Testing(CCIT) , Equivalent Leak Aperture, and Ultra-small equivalent leak aperture detection;
High detection accuracy, minimum detection limit of 0.1μm;
Automated leakage detection of tracer gas, advanced data processing;
Quantitative calculation model for Equivalent Leak Aperture;
Exemption from microbial challenge testing；
Full lifecycle Container Closure Integrity Testing(CCIT)；
No nitrogen purging required;
USP1207 recommended CCIT method;
Overall design complies with GMP and FDA 21 CFR Part 11 standards;
Equipped with user permission control, audit trail and electronic signature functions.

HGA Vial Inspection System (HGA-CCIT)

Description

Parameters

Advantages

Application

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