GBPI GB-V – Vacuum Decay Leak Detection Tester (CCIT Method)
- Non-destructive vacuum decay leak detection tester for container closure integrity testing (CCIT)
- Full testing compliance with ASTM F2338, USP ⟨1207⟩, YY/T 0681.18, and FDA CCIT guidelines
- Exceptional micro-leak detection sensitivity capable of identifying orifice defects down to 1 ~ 3 μm
- Rapid non-destructive test cycle completed in approximately 30 seconds without sample destruction
- Dual-sensor architecture combining high-resolution differential pressure and absolute vacuum transducers
- Custom precision test chambers engineered for ampoules, vials, prefilled syringes (PFS), and eye drop bottles
- Integrated touch HMI with automated pass/fail criteria, audit trail, and 21 CFR Part 11 regulatory compliance
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The GBPI GB-V is a cutting-edge, non-destructive vacuum decay leak detection tester engineered for high-sensitivity container closure integrity testing (CCIT) of parenteral pharmaceuticals, sterile medical devices, and high-value packaging. Built in strict accordance with ASTM F2338 (standard test method for non-destructive detection of leaks in packages by vacuum decay method) and USP ⟨1207⟩ (sterile product packaging integrity evaluation), this deterministic leak testing system replaces subjective blue dye ingress methods with quantitative, repeatable physical measurements.
Sterile injectable formulations, freeze-dried biologics, and pre-filled syringes demand absolute barrier hermeticity. Even sub-visible pinholes or capillary gaps around stopper flutes can introduce microbiological contamination or allow oxygen and moisture ingress, degrading therapeutic potency. Operating as a non-destructive vacuum decay leak detection tester, the GBPI GB-V houses the test container inside an airtight evacuation test cell precisely contoured to the container geometry. A high-performance vacuum source evacuates both the test chamber and reference volume to a preset negative pressure. Once stabilized, the chamber is isolated, and high-frequency differential pressure transducers monitor pressure changes over a defined dwell period. Any microscopic leak orifice causes gas inside the package to migrate into the chamber, generating a measurable pressure rise that correlates precisely to defect orifice size.
Rapid 30-Second Non-Destructive Cycle
Unlike traditional methylene blue dye bath submersion, which destroys tested samples and relies on human visual judgment, the GB-V test cycle takes approximately 30 seconds and preserves 100% of tested product. Non-defective samples can be returned directly to production inventory, substantially reducing quality control testing waste.
Dual-Sensor Precision & Custom Test Cells
The system utilizes a dual-sensor architecture incorporating both absolute pressure sensors and ultra-sensitive differential pressure transducers to achieve micro-leak resolution down to 1 μm. Custom quick-change test cells ensure minimal dead volume around ampoules, rubber-stoppered vials, BFS containers, and dental cartridges.
Equipped with an intuitive touchscreen terminal, automated pass/fail judgment, multi-tiered user access permissions, and complete audit trail functionality, the GB-V meets Good Manufacturing Practice (GMP) validation protocols.
GBPI GB-V Vacuum Decay Leak Detection Tester – Technical Specifications
| Technical Parameter | Specification Details |
|---|---|
| Test Principle | Non-Destructive Vacuum Decay Differential Pressure Method (CCIT) |
| Applicable Standards | ASTM F2338-2009(2013), USP ⟨1207⟩, YY/T 0681.18-2020, FDA CCIT Guidance |
| Vacuum Range | 0 ~ -100 kPa (Deep negative pressure regulation) |
| Detection Sensitivity / Limit | 1 ~ 3 μm nominal orifice micro-leak detection |
| Typical Test Duration | Approximately 30 seconds per test cycle (Non-destructive) |
| Sensor Architecture | Dual-sensor system (Absolute vacuum transducer + High-sensitivity differential pressure sensor) |
| Test Cell Configurations | Precision custom-contoured tooling for vials, ampoules, PFS, and blister packs |
| User Interface & Control | Embedded industrial touchscreen HMI with real-time decay pressure curve plotting |
| Data Integrity & Traceability | Multi-level user access control, audit trail logging, 21 CFR Part 11 compliant |
| Overall Dimensions | 550 mm (L) × 330 mm (W) × 320 mm (H) |
| Instrument Net Weight | Approximately 18 kg |
| Operating Environment & Power | Temperature: 20 ~ 30 °C; RH: Max 80% non-condensing; Power: AC 220 V, 50 Hz |
Key Features & Engineering Highlights
- Non-Destructive Testing Technology: Preserves 100% of tested samples, preventing valuable pharmaceutical batch discard and dye contamination.
- Compliance with ASTM F2338 & USP ⟨1207⟩: Meets current FDA deterministic container closure integrity testing mandates.
- High Sensitivity Micro-Leak Detection: Identifies leak defects down to 1 ~ 3 μm, far superior to subjective visual bubble or dye methods.
- Dual-Sensor Differential Pressure Array: Minimizes baseline drift and external ambient temperature interference during high-vacuum isolation.
- Tailored Low-Dead-Volume Test Cells: Precision-contoured CNC aluminum inserts minimize free air space around containers, maximizing signal-to-noise ratio.
- Rapid 30-Second Test Cycle: Highly suitable for laboratory batch release testing as well as high-throughput statistical quality control.
- Comprehensive Data Integrity: Integrated audit trail, user permission hierarchies, and encrypted export formats ensure full GMP compliance.
Standard Package & Accessories
| Item Description | Quantity |
|---|---|
| GBPI GB-V Vacuum Decay Leak Detection System Mainframe | 1 Unit |
| Integrated Color Touchscreen Industrial Display & Controller | 1 Unit |
| External High-Performance Laboratory Vacuum Pump | 1 Set |
| Custom Precision Container Test Cell Chamber (Customer Specified Sample) | 1 Set |
| Calibrated Orifice Micro-Leak Verification Standard | 1 Pc |
| Power Supply Cord, Vacuum Hoses & Factory Calibration Certificate | 1 Set |
Target Industry Applications
Parenteral Vials & Ampoules
Non-destructive micro-leak testing of glass vials with rubber stoppers and aluminum crimp caps, liquid ampoules, and freeze-dried cake vials.
Prefilled Syringes & Cartridges
Verifying closure integrity between syringe glass barrels, tip caps, plunger stoppers, and dental anesthetic cartridges under USP ⟨1207⟩.
Ophthalmic & Blow-Fill-Seal (BFS)
Testing container closure integrity on low-density polyethylene BFS unit-dose ampoules and multi-dose eye dropper bottles.
Medical Blister Packaging
Evaluating micro-channel leaks and pinholes in cold-form aluminum/aluminum and thermoform plastic/foil pharmaceutical blister packs.