Testing of microbial contamination during the preparation of the radiocompound [ 90Y]DOTATOC for clinical trials: A process validation study by media fill approach

V. Sirna, L. Garaboldi, S. Papi, L. Martano, E. Omodeo Salè, G. Paganelli, M. Chinol

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)553-559
Number of pages7
JournalQuarterly Journal of Nuclear Medicine and Molecular Imaging
Volume54
Issue number5
Publication statusPublished - Oct 2010

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Validation Studies
Clinical Trials
Radiopharmaceuticals
Infertility
Hospital Laboratories
Infection Control
Growth
Microbiology
Radioisotopes
Quality Control
Culture Media
DOTA-Tyr(3)-90Y-octreotide
Safety
Injections
Pharmaceutical Preparations

Keywords

  • Media fill test
  • Radiopharmaceuticals
  • Sterility test
  • Validation studies

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

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title = "Testing of microbial contamination during the preparation of the radiocompound [ 90Y]DOTATOC for clinical trials: A process validation study by media fill approach",
abstract = "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.",
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author = "V. Sirna and L. Garaboldi and S. Papi and L. Martano and Sal{\`e}, {E. Omodeo} and G. Paganelli and M. Chinol",
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T1 - Testing of microbial contamination during the preparation of the radiocompound [ 90Y]DOTATOC for clinical trials

T2 - A process validation study by media fill approach

AU - Sirna, V.

AU - Garaboldi, L.

AU - Papi, S.

AU - Martano, L.

AU - Salè, E. Omodeo

AU - Paganelli, G.

AU - Chinol, M.

PY - 2010/10

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N2 - 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.

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