Microbiology / Container leak detector

Vial and Ampoule Leak Tester Model CCI1000

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The new Leak Test Analyzer model CCI1000 is an instrument for the detection of micro leaks in containers, detection of pores and micropores in vials and ampoules.
Non destructive and quantitative test. According to ASTM F2338-09 method. Vacuum decay leak test.
This new technology offers a highly sensitive deterministic method (less than or equal to 0.09 cm3/m. leak radius) for different types of containers:

  • Loaded or preloaded syringes
  • Empty vials
  • Full vials
  • Vials with lyophilized solid
  • Glass or plastic vials with elastomer seals
  • Blisters
  • Other types of containers
  • Test principle: vacuum drop in rigid or flexible chamber
  • Non-destructive. No gas required.
  • Quantitative (deterministic) results
  • Measuring time: less than 15 seconds
  • Adjustable limit values
  • Vacuum measurement: Basic detection or AddiSens® (additional sensitivity mode)
  • 12″ touch screen
  • Detection limit: better than 0.05 cc/min (approx. 1.5 microns nominal orifice size)
  • Fast measurement cycle (without sample preparation)
  • Integrated suitability test prior to testing (optional)
  • Units of measurement (mBar and Pascal)
  • Data export in csv format via USB or PC connection
  • Multilevel password-protected data integrity
  • Audit Trail available for 21 CFR 21 Part 11 (optional)
  • Laboratory unit, expandable on the production line
  • Easy to clean stainless steel housing
  • Dimensions (WxLxH): 38 x48 x48 cm
  • Weight: 22Kg
  • Power supply: 100-220 Vac; 50/60Hz; 200 VA (without vacuum pump)

Non-destructive detection of leaks in containers.
Detection of pores and micropores in vials and ampoules. 

USP <1207>
ASTM F2338-09
CFR21 part 11
  • Measuring chamber
  • Oil-free vacuum pump
  • Auto test, allows to perform a suitability test automatically before each work session.
  • External software with historical data acquisition and reporting
  • Other accessories on request

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