Container Closure Integrity (CCI) Leak Testing
- Proven InterTech Microscale Technology measures leaks down to the equivalent of a 0.5 micron defect diameter.
- A careful review of application requirements including the Maximum Allowable Leakage Limit (MALL) will dictate the test method used.
- Testing is consistent with ASTM requirements (F-3287-17, F-2338-09).
- Proprietary technology is available for testing with minimal headspace volumes.
- Pressure change, mass flow, and mass extraction under vacuum and positive pressures are available.
- These technologies are non-destructive and deterministic allowing manufacturers to comply with GMP guidelines.
- Applications include the Container Closure Integrity (CCI) testing of vials, assay kit assemblies, cups and combined products.
Standard or custom designed test fixtures meet unique customer application requirements.
The InterTech TechPressTM is an off-the-shelf solution for product development and audit testing.
High speed inline test cells are delivered ready to integrate into the production line.
ASSAY KIT TEST CELL
- MicroScale Leak Test Cell tests Medical Assay Base Assembly to < 0.02 sccm (20 microliters/minute) at 0.2 bar, at rate of 180 parts per hour.
READY TO INTEGRATE TEST CELL
- Parts are leak tested to a 0.008 sccm (8 microliters/minute) at 700 mbar, at a rate of 150 parts per minute.
SEALED PACKAGE AUDIT TEST CELL
- Parts are leak tested to 0.1 sccm (100 microliters /minute) limit at 8.5 psig, at a rate of 120 parts per hour.
Test Features and Benefits
- InterTech’s proprietary MicroScale leak test technology is reliable and offers speed and accuracy superior to competitive pressure testing methods.
- MED75 Microscale Test Instruments are ready to use for both in the lab and on the production line.
- Ethernet/IP capability of test instruments allows seamless integration of test data with all quality assurance systems.
- Remote access creates significant savings in maintenance, product change-over times and reduces time to market
- The implementation of InterTech’s deterministic test technology results in a robust product quality and traceability system.
- 21 CFR Part 11 data requirement compatibility are built into InterTech test instruments and testing solutions.This protects manufacturers and end-users from negative product safety events.
Consult Our Experts
Please contact InterTech for further information or help with your test application. We are happy to answer any questions you may have. Give us a call at 847-679-3377 or fill out the form and we'll be in touch as soon as possible.
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