English
BACK TO PRODUCTS
ABT BG-75 Biomarker Generator
PRODUCT CATEGORY :
SPECIALTIES : Nuclear Medicine

Biomarker Generator BG-75 is an integrated system of in-house fluorine-18 (18F) production and radiopharmaceutical synthesis. It provides a fully automated option of single-dose FDG production every 30 minutes, on demand

DETAILED DESCRIPTION
TECHNICAL SPECIFICATIONS
ACCESSORIES
RELATED FILES
VIDEO

Biomarker Generator BG-75 is a compact system for in-house production of radiopharmaceuticals for PET imaging. It consists of a mini cyclotron of 7.5 MeV energy as well as a Chemistry Production and Quality Control Module. The cyclotron accelerates protons to produce 18F which then is driven to the Chemistry Production Module to create FDG in a single-dose syringe or vial. The synthesis of FDG is performed automatically and easily using disposable Dose Synthesis Cards (DSC) and reagent kit. Also, the Chemistry Production Module has Quality Control Module, integrated with the necessary tests, for the administration of FDG. All the procedures are simplified and automated, therefore no numerous and highly specialized personnel are required to operate the unit. The cyclotron and the Chemistry Production Module are of a compact size and self-shielded, so the room is enough to be 30 m2, without additional shielding and the construction cost of the room is significantly low.

The design of the system and the usage of disposable parts avoid the cross contamination while complies with the cGMP requirements. During design, construction and test in operational conditions of every BG-75 system, thorough studies are being conducted for validation and the results as well as the conclusions are being recorded and provided to the client with the form of validation reports for compliance with cGMP.

  • Cyclotron:
    Proton acceleration to 7.5 MeV.

Target material: stainless steel or tantalum (high performance).

Self-shielding by dense concreate and boronated polyethylene.

Maximum dose rate at room boundaries < 1 mrem/hr.

  • Chemistry Production Module:

Fully automated.

Reagent kit and sterile Dose Synthesis Card for automated and quick radiopharmaceutical synthesis.

Single dose or batch production.

  • Quality control module:

It performs automatically most of the tests required by European Pharmacopeia – pH measurement, radiochemical identity, radiochemical purity, chemical purity, residual solvents, filter integrity.

  • Dose on demand in 45’.
  • Advantages of the system are the low cost of the radiopharmaceutical and the fully controlled dose production.

 

DETAILED DESCRIPTION
TECHNICAL SPECIFICATIONS
ACCESSORIES
RELATED FILES
VIDEO

Biomarker Generator BG-75 is a compact system for in-house production of radiopharmaceuticals for PET imaging. It consists of a mini cyclotron of 7.5 MeV energy as well as a Chemistry Production and Quality Control Module. The cyclotron accelerates protons to produce 18F which then is driven to the Chemistry Production Module to create FDG in a single-dose syringe or vial. The synthesis of FDG is performed automatically and easily using disposable Dose Synthesis Cards (DSC) and reagent kit. Also, the Chemistry Production Module has Quality Control Module, integrated with the necessary tests, for the administration of FDG. All the procedures are simplified and automated, therefore no numerous and highly specialized personnel are required to operate the unit. The cyclotron and the Chemistry Production Module are of a compact size and self-shielded, so the room is enough to be 30 m2, without additional shielding and the construction cost of the room is significantly low.

The design of the system and the usage of disposable parts avoid the cross contamination while complies with the cGMP requirements. During design, construction and test in operational conditions of every BG-75 system, thorough studies are being conducted for validation and the results as well as the conclusions are being recorded and provided to the client with the form of validation reports for compliance with cGMP.

  • Cyclotron:
    Proton acceleration to 7.5 MeV.

Target material: stainless steel or tantalum (high performance).

Self-shielding by dense concreate and boronated polyethylene.

Maximum dose rate at room boundaries < 1 mrem/hr.

  • Chemistry Production Module:

Fully automated.

Reagent kit and sterile Dose Synthesis Card for automated and quick radiopharmaceutical synthesis.

Single dose or batch production.

  • Quality control module:

It performs automatically most of the tests required by European Pharmacopeia – pH measurement, radiochemical identity, radiochemical purity, chemical purity, residual solvents, filter integrity.

  • Dose on demand in 45’.
  • Advantages of the system are the low cost of the radiopharmaceutical and the fully controlled dose production.

 

DETAILED DESCRIPTION

Biomarker Generator BG-75 is a compact system for in-house production of radiopharmaceuticals for PET imaging. It consists of a mini cyclotron of 7.5 MeV energy as well as a Chemistry Production and Quality Control Module. The cyclotron accelerates protons to produce 18F which then is driven to the Chemistry Production Module to create FDG in a single-dose syringe or vial. The synthesis of FDG is performed automatically and easily using disposable Dose Synthesis Cards (DSC) and reagent kit. Also, the Chemistry Production Module has Quality Control Module, integrated with the necessary tests, for the administration of FDG. All the procedures are simplified and automated, therefore no numerous and highly specialized personnel are required to operate the unit. The cyclotron and the Chemistry Production Module are of a compact size and self-shielded, so the room is enough to be 30 m2, without additional shielding and the construction cost of the room is significantly low.

The design of the system and the usage of disposable parts avoid the cross contamination while complies with the cGMP requirements. During design, construction and test in operational conditions of every BG-75 system, thorough studies are being conducted for validation and the results as well as the conclusions are being recorded and provided to the client with the form of validation reports for compliance with cGMP.

TECHNICAL SPECIFICATIONS
  • Cyclotron:
    Proton acceleration to 7.5 MeV.

Target material: stainless steel or tantalum (high performance).

Self-shielding by dense concreate and boronated polyethylene.

Maximum dose rate at room boundaries < 1 mrem/hr.

  • Chemistry Production Module:

Fully automated.

Reagent kit and sterile Dose Synthesis Card for automated and quick radiopharmaceutical synthesis.

Single dose or batch production.

  • Quality control module:

It performs automatically most of the tests required by European Pharmacopeia – pH measurement, radiochemical identity, radiochemical purity, chemical purity, residual solvents, filter integrity.

  • Dose on demand in 45’.
  • Advantages of the system are the low cost of the radiopharmaceutical and the fully controlled dose production.

 

ACCESSORIES
RELATED FILES
VIDEO