Related Experiment Video
Updated: Jun 8, 2026
Enhancing Efficiency and Radiolabeling Yields of Carbon-11 Radioligands for Clinical Research Using the Loop Method
Published on: December 20, 2024
Testing of microbial contamination during the preparation of the radiocompound [⁹⁰Y]DOTATOC for clinical trials: a
1Hospital Pharmacy, European Institute of Oncology, Milan, Italy. marco.chinol@ieo.it
Aim:
Radioisotopes used in nuclear radiopharmacy possess short half-lives, not allowing enough time to wait for completion of sterility tests. Moreover, carrying out sterility tests on highly radioactive solutions inside the hospital microbiology laboratory arises concerns about radioprotection. Therefore, the release of radiopharmaceuticals for injection is allowed in microbial analysis. For this reason, the effectiveness of the aseptic procedures has to be continuously assessed in order to guarantee the safety of the drug. The aim of this study was to validate the sterile preparation of [⁹⁰Y]DOTATOC by means of media fill test.
Methods:
In order to validate the process, a simulation test was used: the media fill test. To apply this method, operators simulated each step of the process using culture medium (Triptic Soy Broth, TSB) instead of actual radiopharmaceutical product. Media fill test procedure has been subdivided into 5 phases, from the simulation of reagent preparation through the dispensing operations up to ward delivery. After every step, the processed medium was incubated at 35 °C for 14 days. If the compounding procedures are adequately performed, no growth of microorganisms will be detected.
Results:
Microbiological analyses, carried out on all vials obtained at the end of each step, showed no microbial growth. For this reason, sterility tests were considered satisfactory.
Conclusion:
Application of media-fill test allowed both to validate operative modality used for [⁹⁰Y]-DOTATOC handling and to attest the ability of operators who worked on it. Additionally, a correct quality control of the radiopharmaceutical i.v. preparations allows clinic infections control and prevention.
Insights
Sterile preparation of [⁹⁰Y]DOTATOC was validated using a media fill test, confirming aseptic procedures and operator competence. This ensures radiopharmaceutical safety and aids infection control.
Area of Science:
- Nuclear Radiopharmacy
- Microbiology
- Quality Control
Background:
- Radiopharmaceuticals have short half-lives, complicating sterility testing.
- Sterility testing of radioactive materials poses radioprotection challenges.
- Ensuring aseptic procedures is critical for radiopharmaceutical safety.
Purpose of the Study:
- To validate the sterile preparation process for [⁹⁰Y]DOTATOC.
- To assess the effectiveness of aseptic techniques through media fill testing.
- To confirm operator proficiency in handling radiopharmaceuticals.
Main Methods:
- A media fill test simulating [⁹⁰Y]DOTATOC preparation was conducted.
- Operators used Tryptic Soy Broth (TSB) instead of the radiopharmaceutical.
- The simulated process involved 5 phases, from reagent preparation to dispensing, followed by 14-day incubation.
Main Results:
- No microbial growth was observed in any of the incubated media fill vials.
- All microbiological analyses confirmed the absence of contamination.
- The sterility tests were deemed satisfactory, indicating successful validation.
Conclusions:
- The media fill test successfully validated the aseptic handling procedures for [⁹⁰Y]DOTATOC.
- The study attested to the competence of the operators involved in radiopharmaceutical preparation.
- Effective quality control of radiopharmaceuticals is essential for preventing clinical infections.
![Automated Radiochemical Synthesis of [18F]3F4AP: A Novel PET Tracer for Imaging Demyelinating Diseases](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F55537.jpg&w=3840&q=50)
![An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F66708.jpg&w=3840&q=50)