LF-SMH Lab scale multi-head CFR21 Part 11 Compliant

Pharmaceuticals

Non-Invasive, Non-destructive Integrity Inspection System for finished and filled containers for in process and off-line control applications.

PLAY VIDEO

Ampoules

Bottles

Carpoules

Flowrapped Device

IV Bags

MDI

MDPI

Pouches

Prefilled Syringes

Vials

Flowpacks

Tech specifications

Highlights

Quick and sensitive test
Zero alteration of container features
Vacuum and positive pressure testing
Fast, reliable and repeatable results
Highly functional, intuitive HMI
Cost-effective solution
System autodiagnostics available

Contact Us

LF-SMH | Lab scale multi-head CFR21 Part 11 Compliant

Technical Features

Container application: Ampoules, Vials, Pouches, MDPI, MDI, IV Bags, Flowrapped Device, Flowpacks PFS, Carpoule, Bottles.
Products: Filled, Empty, Closed
Container dimensions: From 5 x 30 x 5 mm (min) to 86 x 86 x 250 mm (max)
Speed: Up to 20 cpm
Technology: CCIT
Inspection features: Non-Invasive, Non-Destructive CCIT based on Vacuum Decay Method
Inspection Capabilities: Microleaks detection

Additional Benefits

Compact and robust design
Maintenance-free
Quick change over
Low power consumption
Storage, maintenance, and download of historical data (production, raw data, events, alarms)
HMI Real Time display of Testing Cycle diagram
Computerised system is designed to comply with FDA 21 CFR Part 11 and EU Annex 11
Validation Package guarantees complete and efficient regulatory compliance

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