Container Closure Integrity (CCI) Leak Testing
Ensure product safety and quality with InterTech’s proven Microscale leak test technology. Our solutions detect leaks down to the equivalent of a 0.5 micron defect, delivering unmatched precision for pharmaceutical, medical device, and consumer product applications.
Accurate, Compliant, and Non-Destructive
InterTech’s leak testing solutions are designed to meet your specific application requirements, including the Maximum Allowable Leakage Limit (MALL). Testing methods are consistent with ASTM standards F-3287-17 and F-2338-09, ensuring regulatory compliance.
Our proprietary Microscale technology supports testing with minimal headspace volumes, using:
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Pressure change
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Mass flow
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Mass extraction under vacuum and positive pressures
These non-destructive, deterministic methods allow manufacturers to comply fully with GMP guidelines, guaranteeing product safety without compromising integrity.
Applications
InterTech CCI testing is ideal for:
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Vials
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Assay kit assemblies
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Cups
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Combined or multi-component products
Turnkey Solutions
We offer standard or custom-designed test fixtures tailored to unique customer requirements.
InterTech TechPress™ provides an off-the-shelf solution for product development and audit testing, while high-speed inline test cells are ready for seamless integration into your production line.
Example Test Cells:
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Assay Kit Test Cell: Tests medical assay base assemblies to <0.02 sccm (20 μL/min) at 0.2 bar, achieving 180 parts/hour.
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Ready-to-Integrate Test Cell: Leak tests parts to 0.008 sccm (8 μL/min) at 700 mbar, at a rate of 150 parts/minute.
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Sealed Package Audit Test Cell: Tests parts to a 0.1 sccm (100 μL/min) limit at 8.5 psig, at a rate of 120 parts/hour.
Features & Benefits
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Reliable Microscale Technology: Speed and accuracy surpass traditional pressure testing methods.
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Flexible Deployment: MED75 Microscale Test Instruments are ready for both lab and production line use.
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Seamless Integration: Ethernet/IP connectivity allows automatic quality assurance system integration.
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Remote Access: Reduces maintenance and product change-over times, accelerating time to market.
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Robust Data Traceability: Supports 21 CFR Part 11 compliance, protecting manufacturers and end-users from product safety events.
InterTech’s deterministic CCI testing technology ensures fast, accurate, and compliant leak detection—building a reliable foundation for product quality and traceability.