Cyclotron
Olympus
FDG Chemistry
Explora Module
Aseptic Items
100

What happens to most protons that enter a target system in the cyclotron?

They decelerate and release heat.

100

Which of the following pieces of inventory will be tracked by the PETNET Serial Numbers?  (SN-xxxxxxxxxxx).

Controlled Inventory.

100

How long can an Acetonitrile Reagent Vial remain on the Explora FDG4 module to perform production?

48 hours

100

In the Explora FDG4 module, what indication can be seen when a liquid is added to the Reaction Vessel?

A dip in the temperature IR trace will be seen.

100

When cleaning a ISO 5 area, which surface should not be directly sprayed with disinfectant?

The pleated HEPA (High Efficiency Particulate Air) filter.

200

What is the purpose of the Hydrogen gas that is used in the cyclotron system?

It is the source of ions for the Ion Source System.

200

When checking in PETNET inventory, where can you quickly find a list of the material Acceptance Criteria?

Material Requirement Sheet.  (MRS).

200

In the FDG purification column, which trap neutralizes the pH of the final drug product?

IC-HCO3

200

What 2 pumps are used to add liquids to the reaction vessel?

Lee (syringe) pump and vacuum pump.

200

What are the expiration requirements and storage conditions for properly prepared FPVs?

14 days in a clean, dry environment.

300

What is the purpose of the Magnet System in a cyclotron?

To confine the beam to a plane so that it can be accelerated.  (squishes the beam).

300

What is the appropriate action to take if your batch has a low Radiochemical Yield?

If all the QC acceptance criteria are met, you can release the batch and complete a Low Radiochemical Yield Investigation.

300

In FDG purification, what is the purpose of the IC-H cartridge/resin?

Trap Kryptofix (K222)

300

Prior to entering a mini cell to perform Explora Box setup for FDG, what is the first thing you must do?

Determine the radiation level of the mini cell.

300

During daily cleaning of the Hot Cell, what are the contact times for each type of RTU?

Vesta-Syde 10 minutes; Peridox 3 minutes  

400

What 2 pumps create vacuum in the cyclotron Vacuum System?

Diffusion and Mechanical pumps

400

Which statement best describes the rules for assigning expiration dates in Olympus?

Manufacturer Expiry if available, if not assign a 1 year, some inventory has no expiry (gas tanks).

400

What purpose does the Alumina (Al) cartridge serve in the FDG Purification process?

Traps F- ion from the final drug product.

400

What is the purpose of a drying step on the Explora module?

Specifically to remove water.

400

Which statement best describes a wipe that will be used within an ISO-5 environment at a PETNET facility?

Sterile, low particulate wipes from a package that has not been opened more that 24 hours

500

Name the 5 critical systems of the cyclotron.

Vacuum System, RF system, Cooling system, Ion source system, and targetry system. 

500

Who is allowed to release a Final Batch of drug product at a PETNET facility?

Only a fully Authorized Person.

500

What is the purpose of adding ethanol to the FPV for FDG production?

It's a drug stabilizer

500

When is end of synthesis (EOS) for any product?

Once the synthesis program is finished and all activity has been delivered to the final product vial.

500

What Personal Protective Equipment MUST be worn during aseptic techniques in an ISO-5 unit.

Head cover, face cover, low particulate coat, sterile sleeves, sterile gloves, and foot covers.

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