کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2153962 1090214 2013 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Media Fill Test for validation of autologous leukocytes separation and labelling by 99mTc-HmPAO
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی تحقیقات سرطان
پیش نمایش صفحه اول مقاله
Media Fill Test for validation of autologous leukocytes separation and labelling by 99mTc-HmPAO
چکیده انگلیسی

ObjectiveManufacturing 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.MethodsThe 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.ResultsNo evidence of turbidity was observed in all the steps assayed by the Media Fill.ConclusionsIn the separation and labelling of autologous leukocytes with 99mTc-HmPAO, Media-Fill test represents a reliable tool to validate the aseptic process.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Nuclear Medicine and Biology - Volume 40, Issue 1, January 2013, Pages 104–108
نویسندگان
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