LF-400A

Leak Tester

Off-line Machine for Non-Invasive, Non-Destructive Integrity Inspection for laboratory and in process control applications for filled Aerosol Can.

Highlights

  • Quick and sensitive test
  • Compact & maintenance free
  • Vacuum testing
  • Fast, reliable and repeatable results
  • Applicable to any type of pharmaceutical containers
  • Highly functional, intuitive HMI
  • Cost-effective solution

Tech Specification and Features

Technical Features

  • Container Application: Filled Aerosol, Monobloc, MDI, Liquid Forms
  • Products: Liquid
  • Container Dimensions: From Ø8 X 25 mm (H) to Ø65 x 300 mm (max)
  • Speed: Up to 4 Cpm
  • Technology: CCIT
  • Inspection features: Non-Invasive, Non-Destructive CCIT based on Vacuum Decay Method
  • Inspection Capabilities: Microleaks detection

Additional Plus

  • Easy to clean – no hidden corners.
  • Quick format changeover
  • Low power consumption.
  • Real time display of testing cycle diagrams, statistical raw data
  • Easy, quick and safe remote access
  • Barometric Compensation system to avoid any vacuum level reading variations
  • Storage of records: maintenance, production, alarms

Technology

  • Container Closure Integrity Testing is a non-destructive measurement technology based on Vacuum 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.

Quality Assurance

  • Equipment test method refers to:
    • Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
    • 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”
    • FDA 21 CFR part 11 as well as EMA Annex 11
    • Specifications on Chapter 3 of “FEA Guide on Hot Water Bath Testing and Its Alternatives”
    • Machine Measurement System follows the approved industry standard "UN/SCETDG/24/INF.49"