Description
Sistemi di ispezione di vial e siringhe con tecnica Vacuum decay.
I risultati hanno dimostrato di essere superiori e più affidabili rispetto al dye test.
La tecnologia si basa sul metodo di decadimento del vuoto “Vacuum Decay” ASTM F2338-09, riconosciuto dalla FDA.
Benefits:
– Non-destructive, non-invasive, no sample preparation
– Defect detection down to 0.05 ccm
– Highest level of sensitivity, repeatability and accuracy
– Results proven superior to dye ingress
– ASTM test method and FDA standard
Inspection Criteria
– Measures seal integrity of entire container or package
– Measures and verifies container closure system integrity
– Tests for gas leaks for dry products (lyophilized vials, powder filled)
– Tests for liquid leaks (liquid filled vials, pre-filled syringes)
Applications:
– Micro Leak Detection
– CCIT Container Closure Integrity Testing
Package Type
– Empty & pre-filled syringes
– Liquid filled & lyophilized vials (glass or plastic)
– Filled & sealed bottles, FFS bottles
– Non-porous pouches
– BPC (Bulk Pharmaceutical Chemical) containers
– API (Active Pharmaceutical Ingredient ) containers
– BFS containers
– Ophthalmic dropper tip bottles containing liquid materials
– Glass or plastic ampoules containing liquid materials
– Lidded (nonporous trays or cups) containing liquid materials
Test Configuration
– Offline laboratory
- Production line applications
Test System
Vacuum Source
– External electric vacuum pump
Test Method
– Differential vacuum decay
Test Vacuum Range
– Down to 0.1mBar Absolute Vacuum
Operator Interface
– 10" color touch screen
Test Parameter Storage
– Up to 50 packages
Test Sensitivity
– Down to 0.05 ccm (approximate hole size 1.5 micron)
Test Results/Resolution
– Pass/Fail Result
– Absolute Vacuum in mBar and differential in Pascal units
Security Password
– Yes
Remote Internet Access
– Yes
Data Collection
– Collects test data for view on touch screen and electronic data collection
– CFR 21 Part 11 (optional)
Test Chamber
– Manual or automatic
Test Method Approved
- ASTM F2338-09
Test Instrument Enclosure
– Stainless Steel
Options
– Validation Qualification Package (IQ/OQ/PQ)
– Microcalibrator Flowmeter