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Container Closure Integrity Tester CCIT

Manufacturer: Oxipack

Container Closure Integrity Tester CCIT

High-precision vacuum decay CCI tester for pharmaceutical and biological containers – vials, ampoules, bottles – with 21 CFR Part 11 software.

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Key features

  • Non-destructive vacuum decay method to ASTM F2338
  • 21 CFR Part 11 compliant software for secure electronic records and signatures
  • Quick-change parts for differently shaped products
  • Integrated vacuum pump and control system
  • Operator-independent results
  • Fast, accurate leak detection for sensitive pharmaceutical products
  • Suitable for rigid products such as pods, capsules, cans and bottles

Technical data

Dimensions (L x W x H)
465 x 305 x 330 mm
Weight
10 kg
Materials
Powder-coated steel, anodised aluminium, polycarbonate, Onyx
Power supply
100–240 VAC
Compressed air supply
> 5.5 – < 8 bar
Air consumption
100 Nl/min
Compliance and IP rating
CE, IP20, 21 CFR Part 11 (software)
Leak detection method
Vacuum decay, ASTM F2338
Minimum detectable leakage
> 0.9 cm³/min
Maximum testing capacity
2 P/M
Connections
USB/Ethernet data export, 24 VDC logic (freely programmable)
Packaging type and size
Pods, capsules, cans, jars, bottles, vials, cups
Suitable for
Cans, jars, cups, capsules and pods, bottles, vials and ampoules

Description

The CCIT is a high-precision leak tester for the pharmaceutical and biological industries. Format parts are made to fit the container, creating a minimal measuring space and a deep vacuum in the test chamber; this design adapts the machine to many container types, including vials, ampoules and bottles, as well as pods, capsules, cans, jars and cups.

A touchscreen gives a clear overview of settings and results. Leaks are measured with the vacuum decay method (ASTM F2338) – accurate, non-destructive and simple to use for sensitive products.

21 CFR Part 11 software

  • Electronic records: test data are stored securely and protected against unauthorised access or changes.
  • Audit trail: every user action and data entry is logged with a time stamp for full traceability.
  • Electronic signatures: tests can be verified and approved digitally.
  • Access control: multi-level user login with role-based permissions, so only authorised staff can operate the machine or change critical settings.

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