Tema Sinergie

DDS Vials

Automatic dispensing unit for vials

DDS Vials is a GMP compliant system that enables the completely automatic dispensing of open vials with pre-set radiopharmaceutical activities without any operator intervention.

The use of a cleanroom-specific cartesian axis robot avoid the use of slides, carousels and actuators, granting an easy and effective cleaning and decontamination of all surfaces.

The system automatically performs:

  • measurement of the activity sent by the synthesis module, into a dedicated built-in dose calibrator;
  • dilution of the bulk solution to the required starting activity concentration;
  • opened vial sterile filling (no piercing of the septum) with control of the volume through high precision electronic scale
  • plugging and crimping of the filled vial
  • optional dispensed vial activity measurement inside second built-in dose calibrator
  • check of the vial in delivery through built-in barcode reader
  • closed vial delivery into lead pot through double-valve extraction system, without altering the hot cell sterility

DDS Vials is suitable to be installed in Tema Sinergie shielded isolator Mod. DMC3.

 

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Dimensions and Main features
870(w) x 900(d) x 790(h) mm
Built-in barcode reader (for vial identification and traceability)
Provided with n.2 built-in dose calibrators
Total activity concentration measurement and automatic dilution up to the preset final concentration
Automatic single vial moving, cap removal, vial filling and vial crimping

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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