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.

Ampoules

Bottles

Carpoules

Flowrapped Device

IV Bags

MDI

MDPI

Pouches

Prefilled Syringes

Vials

Flowpacks

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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
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Technical Features

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  • 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
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Additional Plus

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  • 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
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Technology

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  • 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.
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Quality Assurance

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  • Equipment test method refers to:
  • Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
  • FDA 21 CFR part 11 as well as EMA Annex 11
  • The Machine Qualification and Validation complies with requirements stated in EU Annex 15