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      PK-VS In-line SVP, Blow Fill Seal CCI Tester

      Pharmaceuticals

      Non-Invasive, Non-Destructive, 100% in-line Integrity Inspection at high production speed

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      Tech specifications
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      Highlights

      • Autotest in real time
      • Easy to validate
      • CFR 21 part 11 compliance and 4.0 full integration
      • Quick format changeover
      • Automatic Drying System, no testing chamber contamination
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      PK-VS | In-line SVP, Blow Fill Seal CCI Tester Contact Us
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      Technical Features

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      • Container Application: Small Volume Parenteral, Blow fill Seal (PK-VS SVP)
      • Products: Liquid
      • Container Dimensions: min: 40 x 40 x 6 mm; max: 150 x 80 x 15 mm
      • Speed: Up to 220 strip/BFS or cards per minute
      • Technology: CCIT
      • Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum Decay Method
      • Inspection Capabilities: Microleaks detection
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      Additional Benefits

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      • Full batch control testing: fast, reliable and repeatable
      • Testing of all nominal production line speed
      • MES (Manufacturing Execution System connection) allows remote machine data exchange & download
      • Statistical Process Control reduces deviations for a better yield control
      • Real time display of testing cycle diagrams, statistical raw data
      • Easy, quick and safe remote access
      • AHE (Automatic Head Exclusion)
      • Easy cleaning
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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 vacuum level as well as the vacuum 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”
      • United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation”
      • EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
      • PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
      • FDA 21 CFR part 11 as well as EMA Annex 11

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