CCIT Tester
The vacuum decay leak test is a non-destructive test method used to detect leaks in packaging to ensure container closure integrity (CCI). The method can be used to identify gross defects and micron leaks in pharmaceutical, medical device and food packaging. Vacuum decay leak testing is an approved ASTM F2338-09 standard test method and is a PDA recognized consensus standard for non-destructive detection of leaks in packages.
BENEFITS
- Non-destructive, non-subjective, no sample preparation
- Defect detection down to 0.005 ccm
- Detection of 5µm, 10µm & 20µm leak
- Highest level of sensitivity, repeatability and accuracy
- Results proven superior to dye ingress
- Deterministic, quantitative test method
- ASTM test method and FDA recognized standard
LT3000 CCIT
The LT3000 CCIT is a deterministic micro leak test system for container closure integrity testing for parenteral products and rigid containers that require precise measurement and detection of the smallest leaks.
TECHNOLOGY
The LT3000 CCIT advances in high vacuum testing has redefined what is achievable with a vacuum-based leak detection technology. LT3000 CCIT technology reduces the baseline measurement for good samples and amplifies the test result for defective samples. This technology is geared towards detecting leaks in the MALL range for parenteral packaging and can also be applied to flexible and semi flexible package formats.
LT3000 CCIT leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.
TECHNOLOGY (CONT.)
Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, results are non-subjective and testing is non-destructive to both product and package.
INSPECTION CRITERIA
- Measures seal integrity of entire container or package
- Measures and verifies container closure system integrity
- Tests for gas leaks for dry products (lyophilized vials, powder filled)
- Tests for liquid leaks (liquid filled vials, pre-filled syringes)
- Vacuum Testing
Container Closure Integrity Testing
SPECIFICATIONS
| Application Package Type | MICRO LEAK DETECTION |
| |
| Test Configuration | Offline laboratory and production line applications |
| Test System* | Dual Transducer Technology |
| Technology* | Differential Vacuum Decay |
| Operator Interface | 7” Color Touch Screen |
| Recognized Test Method | ASTM F2338-09 |
| Base Unit Test Sensitivity** | (Approximate hole size 0.5 micron) |
| Application Sensitivity*** | 0.005 cc/min (Approximate hole size 0.75 micron) |
| Test Results/Resolution | Pass/Fail Result in mBar and Pascal units |
| Test Chamber Tooling | Manual or automatic |
| ASTM Test Method | ASTM F2338-09 |
| Test Instrument Enclosure | ABS |
| Dimensions | 9.8″ W – 6.2″ D x 15.7” H |
| Weight | 28 lbs |
| Power | 100-240 VAC; 50/60 Cycles |
| Air Option | 90 psi compressed air connection and high vacuum pump |
| Validation Qualification Package (IQ/OQ) / Micro calibrator Flowmeter 0.002 cc/min/ |
| Application Package Type | CONTAINER CLOSURE INTEGRITY TESTING |
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+91 9325640285 / 7 / 3