Vacuum decay vial e siringhe

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

Brand

CCIT Package inspection Systems

Nordtest offre sistemi di ispezione per la verifica dell'integrità del packaging e la container closure.