TALIA Series Radiopharmaceuticals Dispensing Isolator

The series of TALIA Radiopharmacetucals Dispensing Isolator is a family of Class A isolators equipped with laminar flow on the entire main chamber.
The radiopharmaceuticals dispensing isolator can house automatic modules or fractioning systems in sterile conditions and in observance of cGMP standards.

Used in Radiopharma Production For Filling Dispensing Dose Calibration
 

The TALIA series is specifically designed for filling, calibrating and fractioning operations on vials or syringes. The machine is ideal for small/large vial (batches of 30 vials per batch) or syringe (batches of 10 5 ml syringes per batch) productions.

The cell guarantees maximum protection for the operator against ionising radiation through complete shielding, the air seal between the chambers and the use of tele-pliers. These characteristics, along with the integrated tools such as the COMECER automatic dispensers, make it particularly suitable for radiopharmaceutical dose preparation, in accordance with cGMP regulations.

The machine has unique setups such as up-to-100-mm lead shielding, double dose calibrator, pass through calibrator integrated in the extraction system, in-line bubble point test and control with 17” touch screen.

Features and Benefits

  • Product extraction system in shielded container by means of specific drawer. The extraction occurs by means of a double airlock system with air quality complying with Class B “At rest” (EEC-cGMP) and Class C “At rest” (EEC-cGMP)
  • 304 AISI stainless steel front coverings, easy to decontaminate, separates the laboratory area (front) from the technical cabinet (rear)
  • 316L AISI stainless steel work chambers with Mirror-Bright internal surface finish, TIG continuous welds, and widely rounded corners
  • Chambers tightness ensured by inflatable gasket system, placed on the perimeter of the openings
  • Shielding elements made with primary ingots (Pb 98% + Sb 2% purity)
  • Filtration system to generate laminar flow in the Class A chamber, made with ULPA U15 absolute filtering cartridge
  • Air inlet filtration system made with HEPA absolute filtering cartridge with 99.995% efficiency
  • Air outlet filtration system made with active carbon filtering cartridge
  • Isolator management, automation and workflow control by means of an operator interface developed in accordance with GAMP regulation and compliant with CFR21 Part 11 requirements
  • 1/8” technical gas supply lines with shut-off valves, which can be controlled from the outside
  • 6 mm technical gas supply line with shut-off valves, which can be controlled from the outside
  • Protected power supply sockets controlled from the operator panel
  • Shielded, sealed inputs for radio-fluids which can be equipped with a “pneumatic dragging” system
  • Cable inlet via multi-diameter seal system
  • Set up for product extraction system equipped with “Pass-through dose calibrator”
  • Set-up for second material introduction chamber (airlock) with air quality complying with Class A “At rest” (EEC-cGMP), provided with laminar flow over the entire area and manipulation gloves
  • Set-up for waste compartment with air quality complying with Class B “At rest” (EEC-cGMP), provided with a passing tunnel with sealed, shielded doors complying with Class B “At rest” (EEC-cGMP)
  • Set-up for semi-automatic Bubble Point Test integrated with COMECER dispensers
  • Tele-pliers on special ball bearings for high sensitivity and precision-movement handling
  • Set-up for the Geiger probes for measurement of the radioactivity present inside the cell
  • Set up for ventilation isolation valves and connection to hydrogen peroxide solution generators (AVC LIGHT) for the dispensing chamber and the material introduction chamber
  • Set up for automatic leak tests on the dispensing chamber and material introduction chamber
  • Set-up for particle counter sensor in the main chamber and in the preparation chamber in “class A”
  • Connection for DOP test (filter sealing test) for absolute filters
  • Connection for sanitation system with VPHP (vapor-phase hydrogen peroxide) through manual or automatic valves

Highlights

  • Available with up-to-100-mm lead shielding
  • Spacious work chamber for the maximum ergonomics
  • Material introduction chamber (airlock) with air quality complying with Class B “At rest” (EEC-cGMP) and equipped with handling gloves.
  • Up to two shielded compartments for dose calibrator, equipped with a pneumatic system for moving vials in the well. The double compartment set-up allows managing a bulk calibrator and a final vial or syringe calibrator
  • Shielded dispensing chamber under constant negative or positive pressure
  • 17” touch-screen operator panel, suitable for use in a classified laboratory, to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode
  • Internal monitoring of temperature and humidity
  • Modulating valves for the inner pressure automatic adjustment

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