PHAEDRA
Radiopharmaceutical Dispensing Isolator for Vials and Syringes

The Phaedra Isolator

• ensures high ergonomics and operative rapidity in pre-production stages (introduction of vials, syringes and disposable in the aseptic area) and post-production stages (removal of disposable and cleaning)
• ensures flexibility during management and extraction of final containers, either in vial format or as syringes or cartridges, thanks to the new universal extraction system equipped with integrated calibrator
• makes significant productions possible with batches of up to 20 vials (15 ml) even as a compact solution, only 175 cm wide
• ensures safe recovery of the pharmaceutical in the event of emergency or malfunction, thanks to the possibility of access with one’s hands with no need to open the front door (the aseptic condition is ensured by the presence of gloves and intermediate isolation door)
• lets operators easily manage manual production processes in case of loading syringes for C11 injections, production of short half-life radio-pharmaceuticals or test productions and R&D
• is connected to decontamination systems with hydrogen peroxide (VPHP) either integrated by Comecer, or by third parties, with the option of activating “rapid gassing” cycles thanks to direct injection in chamber
• ensures easy operation thanks to a user-friendly touch screen interface, integrating dispenser and dose calibrator controls
• maintains the utmost compatibility with GMP lines

The 75 mm lead shielding makes it suitable for dispensing high activity PET emitters, mainly managed with the tele-pliers, while the hand door makes it possible to act quickly inside the aseptic chamber during consumable removal, cleaning and preparation of the new batch, assuring a continuous production process (back-to-back) with no need to open the front shielded door. This approach enhances operative speed while preserving operator exposure.

Ergonomics

The ergonomics of the Phaedra isolator has been designed so that the operator can appreciate the benefit of having two different approaches to dispensing, a characteristic usually hard to integrate in compact and low-cost solutions, such as:

• cells based on manipulation with the aid of the tele-pliers: these ensure complete radioprotection, but they often remain in a side position where they are unable to reach many of the work areas of the aseptic chamber. Furthermore, the tele-pliers are unable to cover the areas close to the front access door due to necessary constructive constraints.
• cells based on manipulation through hand doors: on the contrary, these are placed at the front and make it possible to cover a very wide area, but limit access to the furthermost part from the cell due to constraints of the gloves and human physiognomy.

The combination of these two worlds has been achieved in the Phaedra thanks to the presence of the tele-pliers in a central position with respect to the hand doors. Positioning the tele-pliers in the central point of the cell is only possible because of the introduction of the QuickFix system on Comecer tele-pliers. This system makes it possible to release the rod of the tele-pliers without losing chamber tightness and with no need for complex operations on mechanical parts. Thanks to this system the rod of the tele-pliers may be removed easily and therefore allows access to the hand doors without having the control bar in an inconvenient position. Furthermore, the tele-pliers’ disconnection allows opening the front shielded door without losing tightness and being able to work with the gloves while maintaining the chamber classified and in aseptic condition.

Flexibility

The flexibility of the Phaedra isolator is the result of the application of a variety of innovative technical solutions:

• QuickPlug system for rapid and airtight release of the tele-pliers
• vials and syringes extraction system able to easily switch formats, thanks to a mechanical adaptation system of the duct
• possibility to unload unshielded syringes, ready for distribution
• a central dose calibrator, which may be reached in case of manual manipulation, and may be used to measure bulk concentration
• the possibility to integrate a through calibrator, then a second dose calibrator, in the extraction system for shielded syringes or vials
• the possibility to integrate label printing systems (E-LABEL) in the vial unload system, supporting a GMP approach that entails printing the label downstream of the production process and not prior to filling.

GMP Compliance

The Phaedra isolator ensures compliance with GMP regulations since it is equipped with:

• a Class A chamber featuring laminar flow on the whole work area, ready for a rapid VPHP decontamination system
• a Class B pre-chamber equipped with glove flange that ensures correct opening of the double sterile packets for vials, syringes and disposable and ready for a rapid VPHP decontamination system
• a particle monitoring system in the main chamber and prechamber that can be integrated in the cell’s control panel
• a solid waste system, independently shielded and isolated, able to take in the solid waste produced during the various stages of the process
• a vial/syringe extraction system equipped with double isolated chamber able to ensure the absence of any back-contamination even in the event of unloading in non classified areas
• a ventilation system ready to perform automatic tightness tests
• a hygienic design of the work surface and classified areas that make them excellently cleanable and decontaminable
• cell management through the CFR21 PART 11 control system

In conclusion, the combination of the above factors makes Phaedra a unique product in the field of nuclear medicine and radiopharmaceuticals, as it ensures a compact and streamlined solution addressing the growing need for operative flexibility during dispensing of radiopharmaceuticals.

Main Features

• 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
• 75 mm lead shielding
• 15” touch-screen operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode
• 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
• Shielded entry for radioactive fluids
• Cable inlet via multi-diameter seal system
• Temperature and humidity sensor
• Connection for DOP test (filter sealing test) for absolute filters
• Semi-automatic Bubble Point Test integrated with COMECER dispensers
• Predisposition of a Geiger-Muller probe to detect radioactivity inside the cell and door interlock management
• Set-up for an automatic ventilation closing system (AVCL) with possibility to connecting hydrogen peroxide generators (VPHP)
• Set-up for a particle counter sensor in the main chamber and in the material introduction pre-chambe

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