White paper:
Dose Dividers

In the field of radiopharmacy there are numerous isotopes that can be used to diagnose and treat patients. All these different isotopes must be divided in patient specific doses. Due to the short half-life of most adiopharmaceuticals efficient aliquoting is essential.

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CHALLENGES WHEN DIVIDING RADIOPHARMACEUTICALS INTO PATIENT DOSES

At Von Gahlen we have designed dose dividers specifically for fast dispensing of radiopharmaceuticals into multi or unit dose vials. In this whitepaper we will focus on two dose dividers: the Open Vial Dose Divider – Semi Automatic (OVDD -SA) and the Closed Vial Dose Divider – Semi Automatic (CVDD-SA). For both models the vial handling between device and tray will occur by ball tong manipulators, therefore the devices are considered semi-automatic. The dose divider hardware and software are designed for GMP compliant dispensing.

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RADIOPHARMACEUTICAL DISPENSING SOLUTIONS THAT FIT YOUR NEEDS

Dispensing radiopharmaceuticals into vials needs to occur with high accuracy. To ensure that each vial contains the accurate dose, our dose dividers work based on weight-controlled filling. The software offers the option to generate batch protocols which enable efficient aliquoting of patient specific doses within one batch. The accuracy of the final activity dose per vial is 10%.

By measuring both the bulk bottle and the vial, a weight deviation of maximum 5% is achieved. The dose dividers have a cycle time of 55 seconds to dispense 5 mL of product.

To establish GMP compliance, the dispenser is easy to clean and resistant to common laboratory cleaning agents, including hydrogen peroxide vapor. To prevent contamination between batches a single-use, ETO sterilized disposable set with sterility filter is used. After each batch the integrity of the sterility filter is assessed with a bubble-point test. Additionally, the specific design of the acrylic airflow guide ensures laminar downflow over the vial during filling when used in a GMP grade A environment.

White paper - Dose dividers

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DIVIDING RADIOPHARMACEUTICALS INTO MULTI DOSE OR UNIT DOSE VIALS

Learn more about fast dispensing of radiopharmaceuticals into multi or unit dose vials. Download our free white paper here.

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