Media Fill Test for validation of autologous leukocytes separation and labelling by 99mTc-HmPAO

Nicoletta Urbano, Sergio Modoni, Orazio Schillaci

Research output: Contribution to journalArticle

Abstract

Objective: Manufacturing of sterile products must be carried out in order to minimize risks of microbiological contamination. White blood cells (WBC) labelled with 99mTc-exametazime (99mTc-hexamethylpropyleneamine oxime; 99mTc-HMPAO) are being successfully applied in the field of infection/inflammation scintigraphy for many years. In our radiopharmacy lab, separation and labelling of autologous leukocytes with 99mTc-HMPAO were performed in a laminar flow cabinet not classified and placed in a controlled area, whereas 99mTc-HMPAO radiolabelling procedure was carried out in a hot cell with manipulator gloves. This study was conducted to validate this process using a Media Fill simulation test. Methods: The study was performed using sterile Tryptic Soy Broth (TSB) in place of active product, reproducing as closely as possible the routine aseptic production process with all the critical steps, as described in the our internal standard operative procedures (SOP). The final vials containing the media of each processed step were then incubated for 14. days and examined for the evidence of microbial growth. Results: No evidence of turbidity was observed in all the steps assayed by the Media Fill. Conclusions: In the separation and labelling of autologous leukocytes with 99mTc-HmPAO, Media-Fill test represents a reliable tool to validate the aseptic process.

Original languageEnglish
Pages (from-to)104-108
Number of pages5
JournalNuclear Medicine and Biology
Volume40
Issue number1
DOIs
Publication statusPublished - Jan 2013

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Keywords

  • Tc-HmPAO
  • Aseptic assurance
  • Media Fill test
  • Radiolabelled leukocytes
  • Sterility

ASJC Scopus subject areas

  • Cancer Research
  • Molecular Medicine
  • Radiology Nuclear Medicine and imaging

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