The planning and design of a new PET radiochemistry facility

Mark S. Jacobson, Joseph C. Hung, Trenton L. Mays, Brian P. Mullan

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

The objectives of the Mayo positron emission tomography (PET) radiochemistry facility are the production of PET drugs for clinical service of our in-house patients, commercial distribution of PET drug products, and development of new PET drugs. The factors foremost in the planning and design phases were the current regulatory climate for PET drug production, radiation safety issues, and effective production flow. A medium-energy cyclotron was preferred for its small footprint to allow a compact vault, its high-proton energy to offer a higher product radioactivity; and its research capabilities. A vault installation was chosen instead of a self-shielded machine for improved access and ease of maintenance. Adjacent to the cyclotron is an area that houses the support equipment and a large dedicated workshop to support machine maintenance and targetry development. The total floor area of the PET radiochemistry facility is 344.2 m2 (3,705.5 ft2), of which the radiochemistry laboratory occupies 130.7 m2 (1,407 ft2). To reduce environmental contamination of PET drug products, the laboratory contains a controlled-air environment class 10,000 (M5.5) clean room with access via an interlocking entry change area. A fully shielded isolator (class 100 [M3.5]) is located in the clean room. The PET drugs are delivered via shielded tubing between the synthesizer and isolator. Inside the isolator, there is an automated device for dispensing the PET drug into either a bulk-activity vial or a unit-dose syringe. The dispensed PET radiopharmaceutical then passes through a hatch to a dedicated area where it is packaged for in-house use or commercial distribution. Unit doses for in-house patients are transported via pneumatic tube to the PET imaging area 76.2 m (250 ft) away. There is extensive radiation area monitoring throughout the facility that continuously measures radiation levels. We believe that our new PET radiochemistry facility not only meets overall objectives, but also provides an ergonomic, efficient working environment for the production and development of PET drugs.

Original languageEnglish (US)
Pages (from-to)119-127
Number of pages9
JournalMolecular Imaging and Biology
Volume4
Issue number2
DOIs
StatePublished - Jan 1 2002

Keywords

  • Controlled environment
  • Cyclotron
  • FDA guidelines
  • Hot cells
  • Isolator
  • Positron emission tomography PET
  • Production flow
  • Radiation safety
  • Self-shielded
  • Vault

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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