LF-S11

Benchtop CFR21 Part 11 Compliant CCI Tester

Non-Invasive, Non-destructive Integrity Inspection System for laboratory and in process control applications.

Highlights

  • Quick and sensitive test
  • Compact & maintenance free
  • 3 configurations: BASIC, XL, SY
  • Vacuum and positive pressure testing
  • Applicable to any type of pharmaceutical containers
  • Solutions in place for PFS, LVP, cartridges

Tech Specification and Features

Technical Features

  • Container Application: Vials, PFS, Pouches, Strip Packs, Strip, BFS, IV Bags, Cartridges, Ampoules, Carpules, other Medical devices
  • Products: Lyo, Liquid, Powder, Solid, Semi-solid
  • Container Dimensions: Up to 1000 ml
  • Testing time: From a few seconds to about 1 minute according to container size
  • Technology: CCIT
  • Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum & Pressure Decay Method
  • Inspection Capabilities: Microleaks detection

Additional Plus

  • Quick format change over
  • Automatic plunger stopping device for PFS
  • Auto-diagnostics verifies optimal working condition of the testing chamber and enables machine start-up
  • Easy, quick and safe remote access
  • Barometric Compensation system to avoid any vacuum level reading variations
  • Highly functional, intuitive HMI
  • Real time display of testing cycle diagrams, statistical raw data
  • Storage of records: maintenance, production, alarms

Technology

  • Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
    • Vacuum Decay Method
    • Pressure Decay Method
  • Measurement system comprises applying a pressure differential into an airtight testing group enclosing the container.
  • The test objective is to detect container leakages by measuring the reached pressure level as well as the pressure change over test time.
  • Lid deflection technology can also be implemented to detect leaks on foils of cups or pouches together with Vacuum Decay method.

Quality Assurance

  • Equipment test method refers to:
    • FDA 21 CFR part 11 as well as EMA Annex 11
    • United States Pharmacopoeia - USP General Chapter «1207» “Packaging Integrity Evaluation”
    • EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
    • PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
    • Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”