LT-Pro Leak Tester Flexible CCIT benchtop leak tester

Pharmaceuticals

Non-invasive, non-destructive leak tester for laboratory and in-process control applications. Provides accurate and reliable closed container integrity testing (CCIT) for rigid and flexible packaging.

icon-01 PLAY VIDEO

BFS

Bottles

Carpoules

Cartridges

FFS

Pouches

Prefilled Syringes

Vials

Flowpacks

Cups

icon-23

Highlights

  • Enhanced flexibility
  • Interchangeable tooling for testing a wide variety of containers
  • Multiple test methods: vacuum and pressure decay
  • Available with either 5μm or 1μm test accuracy
  • Non-invasive, non-destructive testing of personalized medicine
  • Small-batch testing
  • Ergonomic design: lightweight, compact, easy to operate, clean, and move.
  • Simple Ewon connection makes it easy to store, analyze, and document test results.
icon-19

Technical Features

icon-12
  • Container Application: Vials, ampoules, BFS, FFS, bottles, prefilled syringes, carpoules, cartridges, trays, pouches, sachets, flowpacks, cups, and other flexible and semiflexible filled-and sealed packaging
  • Products: Lyo, liquid, powder, pastes, solid, semi-solid
  • Container Dimensions: From 0.1 mL to 1 L
  • Testing time: From a few seconds to approximately 1 minute depending on container size
  • Technology: CCIT
  • Inspection Feature: Non-invasive, non-destructive CCIT based on vacuum & pressure decay test method
  • Inspection Capabilities: Weak seals, channel leaks, and pinholes, leaking cracks, inappropriate welds, improper sealing, tears.

Available with either 5μm or 1μm accuracy, select the LT-Pro Leak Tester that best meets your container testing needs using the comparison chart.

 

 

 

icon-20

Additional Benefits

icon-12
  • Feasibility testing of new products and concepts
  • Random batch certainty testing, and even higher sensitivity testing given longer test times.
  • Customizable and intuitive HMI
  • Customizable test types, data requirements, preferred unit of measure, and test time
  • Screen layout is common across all test types, reducing the need for training and documentation
  • Fingerprint-resistant touchscreen is latex glove compatible
  • Easy Ewon connection to OPC UA/DA for remote support, assistance and troubleshooting in real-time
  • Integrated WLAN connectivity (in addition to the classic LAN connection)
  • Housing and one-piece cover designed to prevent contamination
  • Suitable for limited lab space or portable for temporary in-line or next-to-line use
  • Calibration kit included with easy-to-use instructions
icon-21

Technology

icon-12
  • Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
  • Vacuum Decay Test Method
  • Pressure Decay Test Method
  • Measurement is achieved by applying a pressure differential into an airtight testing chamber 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.
icon-22

Quality Assurance

icon-12
  • Equipment test method refers to:
    • Approved industry standard "ASTM F2338-09": "Standard Test Method for Non-Destructive Detection of Leafs 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
  •  
  •  

Learn more about this product