Pharmaceutical

LF-S11


Offline CFR21 compliant Container Closure Integrity Tester

The Machine is designed for Non-Destructive Integrity Testing of Containers and it is suitable for laboratory applications, statistical purposes as well as off-line testing.
Measurement System comprises applying a pressure differential into an airtight Testing Group enclosing the Container (Patent No. 1225063 of 13-9-1988). The test objective is to detect Container leakages by measuring the reached pressure level as well as the pressure change over test time.
The Measurement System follows the approved industry standard "ASTM F2338-09 - Standard Test Method for Non-Destructive Detection of Leaks in Packages”.
The Test method is a Recognised Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006.

Handled container Vials, Pre Filled Syringes, Pouches, PFS Nest, Monobloc, IV Bags, Flowrapped Device, FFS, Carpule, Bottles, BFS, Ampoules, Liquid Forms,
upon packaging/container specific features evaluation
Container Filling Filled, Empty, Closed
Container Content Solid, Semi-solid, Powder, Lyophilised, Liquid
Machine Type Laboratory Leak Tester
Technical operations Vacuum Decay, Pressure Decay
Max speed 4 cpm
Min Container Dimension 8 x 8 x 5 mm
Max Container Dimension 250 x 250 x 300 mm
Technical data may be changed without notice

Extensive pharmaceutical product testing experience goes into every LF-S11 equipment.
Some of these features are:

  • Applicability to most pharmaceutical containers
  • Bonfiglioli Engineering has conducted studies comparing the statistically significant differentiation capability of our system against others in the market and we are confident that our results are industry leading
  • Market leading test cycle time reduces overall time for batch testing
  • Barometric Compensation system: it avoids any vacuum level readings variations due to environmental atmospheric pressure fluctuations
  • Convertible method of testing (vacuum VS positive pressure) with no need to change mechanical components
  • Technical solution in place to prevent plunger movement when testing pre-filled syringes
  • We have used our experience in pharma market and other regulated industrial sectors to create a highly functional, intuitive HMI and control system that is robust, easy to use, displays real time testing cycle diagrams, statistical, and raw data, and provides for storage, maintenance, and download of historical data (production, raw data, events, alarms). The computerized system contains the required technical elements to be compliant with EU Annex 11 and 21 CFR part 11 FDA regulations
  • This very high level of capability and versatility comes in a unit that is compact, durable, virtually maintenance free, and cost effective. It has quick change capability to switch between formats rapidly