Vacuum decay leak tester
Is my container leaking? | Is my packaging still airtight? CCI 1000 is the answer
CCI 1000 is the new , state of the art, vacuum decay based, testing instrument capable to measure on various types of containers made of glass, plastic, metal, flexible composite :
- Liquid filled ampoules
- Sealed Vials (empty, Liquid or lyo filled)
- Pre-filled syringes (liquid filled or empty)
- Pouches and sachet
- Bottles, filled and sealed
- Bulk containers small size
- Ophtalmic dropper tip
The measuring principle
Vacuum decay is the most established and widely used test methods for the detection of leaks from small and medium size containers and packages.
It is non-destructive, quantitative i.e. deterministic, fast, it does not require special gas
The quality of design and construction of the vacuum circuits and electronics are critical to assure
- sensitivity (minimum size of leaks detectable in a defined container)
- repeatability of measurements ( day-to-day, shift-to shift, sample to sample), i.e. the reliability of the test speed of measurement, i.e. productivity
Software
The software design and concept are intended to assure:
- Ease of use
- Completeness of information, both for routine QC and for RD
- Data protection and integrity, through multi-level passwords, data export capability
- Possibility to extend to CFR 21 part 11 standard (Audit trail and data integrity assurance)
Key factors to run successful applications is the choice of the right measurement chamber design for the container and the help of experienced manufacturer to develop the best recipe, i.e. the optimal set of testing parameters.
The duration of each measurement is always less than 15 sec, the result is immediately displayed and requires no interpretation. Setup of one new method can be done in one hour to one day, depending upon complexity, sample homogeneity and required sensitivity, which in turn depends upon MALL (Maximum Allowed Leakage Level).
CCI 1000 can be offered with the widest choice of measurement chambers, for different type of containers.
The capability of precise quantification of the vacuum change provides the valuable information to enable easy validation of the method.
Traceable result generation and data integrity is the key to validation and third-party qualification
We can also provide certified defected positive samples, calibrated orifices of different diameters and dedicated adjustable calibration tools.
Specifications
- Test principle: Vacuum decay in rigid or flexible chamber
- Non destructive. No gas required
- Reference Methods: ASTM F2338-09, USP 1207
- Quantitative results (deterministic)
- Adjustable limit values
- UniVAcuum® Uniform Vacuum design Vacuum measuring
- Basic sensing or AddiSens®:(additional sensitivity mode)
- HMI: 12” Touch screen, Windows based, by Siemens®
- Limit of detection: better than 0.05 cc/min (approx. 1,5 micron nominal hole size)
- Typical 10 sec or less; it depends on application
- Built-in suitability test before session or when required
- Up to 15 different recipes easily generated and selectable
- Different units ( mBar or Pascal)
- One touch button operation
- Output as pass /fail with large green/red lights and number shown
- Up to 100 results of the session available from HMI
- Data export in csv format via USB or PC connection
- Data integrity protected by user multi-level password
- Audit trail available for CFR 21 Part 11 (option)
- Laboratory unit, extensible at production line
- Easy-clean Stainless Steel case
- Dimensions: 380mm W x 480 L x 480 H
- Weight: 22 kg
- Power: 100-240 VAC; 50/60 Hz; 200 VA (without vacuum pump)
- CE Marked
