Process and device for preparing radiopharmaceutical products for injection

Abstract

Method for preparing, packaging and handling an individual dose of a radiopharmaceutical compound, comprising the following steps: filling a cartridge (1) with said dose of radiopharmaceutical compound via a first end, the second end being closed by means of a component serving as a piston (3); closing said cartridge (1) at said first end by means of a closure device (2); placing said cartridge (1) in a radiation shielding device (10), comprising an inner part (4) and an outer part (5), said inner part serving as radiation shielding for an operator and said outer part serving as a transportation shielding container; closing said container by means of an appropriate shielding lid (6); transporting said container up to the place at which an injection of said radiopharmaceutical compound will take place; removing the shielding lid (6) of the container; fixing a plunger (7) to the cartridge piston (3); extracting the cartridge and the inner part (4) of the radiation shielding device (10) from the outer part (5) serving as a container, and placing injection means (30) on the cartridge end which has the setting closure device (2).

Description

[0001] The present invention is related to practices in nuclear medicine, and in particular to a process for preparing radiopharmaceutical products for injection.STATE OF THE ART[0002] The development of nuclear medicine, in particular in the field of diagnosis by positron emission tomography (PET), makes it necessary to review the usual methods for producing, packaging and handling radiopharmaceutical substances intended for administration to patients.[0003] Radiopharmaceutical substances are chemical compounds labeled with radioactive isotopes, intended for medical use. Problems of existing methods and equipment are mainly due to the increase in the use of isotopes whose radiation energy is relatively high, and by the fact that a higher level of automation is required due to the short half-life of said isotopes.[0004] Dose fractionation systems are available on the market. They make it possible to dilute a base radiopharmaceutical product, to prepare the dilute solution in vials a...

AI Technical Summary

Benefits of technology

[0034] The aim of the present invention is to offer a method and a device for producing, packaging and handling injectable substances of radiopharmaceutical compounds, preferably in the form of individual patient-doses of radiopharmaceutical compounds, allowing the exposure of the staff, the number of manipulations and the need for accessory equipment to be reduced to the minimum, while maintaining isolation and sterilization of said compounds from the external environment.

Problems solved by technology

Problems of existing methods and equipment are mainly due to the increase in the use of isotopes whose radiation energy is relatively high, and by the fact that a higher level of automation is required due to the short half-life of said isotopes.

This handling exposes the hospital staff on a repeated basis, giving rise to an appreciable cumulative exposure.

This dose is generally limited by performing the operation behind lead protection such as a radiation-shielded glove box.

It is slow and labor-intensive.

It should be noted that automation of the filling of syringes is possible and that such devices exist, but they do not solve all the production problems: the fixing of the needle or a stopper is not automated, nor is the placing of the syringe in its transportation container.

The integrity of the product is not ensured during the transportation.

This manipulation represents an exposure to radiation and presents a risk of radioactive contamination of the staff, and also a risk of biological contamination of the substance.

A multi-dose radiopharmaceutical vial dispensing device is of little interest to the American market since it does not allow the automatic filling of individual patient-doses which may be used directly in hospitals according to the common practice.

syringes are a form of packaging which does not lend itself readily automation.

The design of a system for the automated filling of syringes, which would directly satisfy the need and habits of the American market, would be complex;

the filling of a syringe as is currently performed in American radiopharmacies, in particular for PET applications, is essentially manual, slow and relatively inefficient;

However the configuration of this device implies that, before transportation, the syringe has to be filled and the needle capped manually, thus exposing the operator.

Thus the medical staff carrying out on-site injection is further exposed during uncapping and during injection. the fixing of the needle or a stopper is not automated, nor is the placing of the syringe in its transportation container.

The integrity of the product is not ensured during the transportation.

This manipulation represents an exposure to radiation and presents a risk of radioactive contamination of the staff, and also a risk of biological contamination of the substance.

A multi-dose radiopharmaceutical vial dispensing device is of little interest to the American market since it does not allow the automatic filling of individual patient-doses which may be used directly in hospitals according to the common practice.

syringes are a form of packaging which does not lend itself readily to automation.

The design of a system for the automated filling of syringes, which would directly satisfy the need and habits of the American market, would be complex;

the filling of a syringe as is currently performed in American radiopharmacies, in particular for PET applications, is essentially manual, slow and relatively inefficient;

A first drawback of this device is the need to manually remove a sealing rubber stopper at the front face of the syringe in order to place the needle, which leads to personal exposure and possible sterility loss or biological contamination.

Moreover the cantilevered gasket-plunger connection is weakened owing to the weight of shielded parts. the fixing of the needle in a stopper is not automated, nor is the placing of the syringe in its transportation container.

This manipulation represents an exposure to radiation and presents a risk of radioactive contamination of the staff, and also a risk of biological contamination of the substance.

A multi-dose radiopharmaceutical vial dispensing device is of little interest to the American market since it does not allow the automatic filling of individual patient-doses which may be used directly in hospitals according to the common practice.

syringes are a form of packaging which does not lend itself readily to automation.

The design of a system for the automated filling of syringes, which would directly satisfy the need and habits of the American market, would be complex;

the filling of a syringe as is currently performed in American radiopharmacies, in particular for PET applications, is essentially manual, slow and relatively inefficient

Possible contamination or exposure of the radiopharmacies staff is thus a risk inherent to manual handling of syringes.

However usual syringes constitute a form of packaging which does not lend itself readily to automation.

The design of a system for the automated filling of syringes, which would directly satisfy the need and habits of the American market, would be complex;

the use of individual syringes does not entirely avoid manipulations at the hospital since they must be transferred from their transportation radiation shielding container to the syringe radiation shielding;

pre-filled individual syringes, possibly comprising needle, syringe body and plunger, are very long and require large, and thus heavy, transportation radiation shielding containers;

when the syringes are delivered with a stopper, an additional manipulation is necessary, which exposes both the product and the operator.

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