Tema Sinergie

CRP6

Filling and crimping unit for vials

CRP is a precise and compact system for dispensing and sealing vials of radiopharmaceuticals in sterile conditions. It allows safe and rapid radiopharmaceutical dispensing into vials minimizing the operator’s tasks.
It is suitable for any laminar flow hot hell with a dose calibrator pit and tele-pliers.

The main parts of the unit are:

  • Opening/Closing/Crimping unit with:
    • station for rubber cap removing/positioning;
    • station for aluminum ring removing/positioning;
    • station for aluminum ring crimping;
    • actuated arm for vial moving among the above stations.
  • A diluting/filling unit
  • A piercing unit
  • Additional stand-alone balance for faster activity concentration calculation (optional)

The system automatically performs the following functions:

  • It measures both total and specific activity delivered by the synthesis module
  • It dilutes the main vial to the required specific activity
  • It fills open or closed vials, controlling the volume, using a built-in high precision electronic scale
  • It plugs and crimps the filled vial (if open vials)
  • It is possible to carry out the bubble point test (instruments not included) without touching the contaminated filter

A computer and operating software, compliant with GAMP5 and CFR21 (Image 3), are supplied together with a touch screen monitor, an optional dose calibrator and a printer for lead container labels and reports.

 

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Dimensions, Weight and Main Features
Overall dimensions: 280 x 520 x 400 mm
Weight: 45 Kg

  • Built-in barcode reader (for vial identification and traceability)
  • Total activity concentration measurement and automatic dilution up to the preset final concentration
  • Automatic cap removal, vial filling and crimping
  • Built-in high precision electronic scale

Performances
Volume precision: <1% for volumes > 1ml
Filling time: 60sec for 10ml vials

  • GAMP5 and FDA 21 CFR part. 11 compliant
  • N. 3 safety passwords (programmable): user, maintenance and RSO password
  • Customizable user accounts
  • Reports and Statistics: end of dispensing cycle, alarms & events (Audit Trail), operatoractions. Auto saving into a neither corruptible nor modifiable file (encrypted)
  • Automatic periodical back-up
  • Daily or weekly work schedule (i. E. Patient list) can be imported from USB pen (or from Hot Lab Management software if interfaced)
  • On-line downloadable database (excel and encrypted files)

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FLEX hot cell mounting the CRP vial dispenser