Simple Solution for Single Final Vial Filling of Ga-68 Radiopharmaceuticals in One Hot Cell Isolator at Small-Scale Radiopharmacy Laboratories under Aseptic Conditions-Reference-Cited by-同舟云学术

Simple Solution for Single Final Vial Filling of Ga-68 Radiopharmaceuticals in One Hot Cell Isolator at Small-Scale Radiopharmacy Laboratories under Aseptic Conditions

Published:2020-06 Issue: Volume:850 Page:225-229
ISSN:1662-9795
Container-title:Key Engineering Materials
language:
Short-container-title:KEM

Author:

Rozenšteins Harijs¹,Zicāns Jānis²,Mutere Olga³,Bērziņa Rita⁴,Merijs-Meri Remo²,Kusiņš Toms⁵,Reinholds Ingars⁶,Mazkalniņa Līva⁷,Švirksts Kārlis¹,Kovaldins Ričards¹,Kizane Gunta³,Grīnbergs Andrejs¹

Affiliation:

1. Kodolmedicinas Klinika Ltd

2. Riga Technical University

3. University of Latvia

4. Institute of Polymer Materials, Faculty of Materials Science and Applied Chemistry, Riga Technical University

5. Riga East University

6. Institute of Food Safety, Animal health and Environment BIOR

7. Kodolmedicīnas klīnika (Nuclear Medicine Clinic), Ltd.

Abstract

A simple solution for fulfilling biosafety and national drug agency demands of radiation and biosafety during Ga-68 radionuclide containing radiopharmaceutical production (RP) by small scale laboratories has been demonstrated based on a novel sterile seal concept of multi-layer bag system prototype. These mid-and inner enclosures of the prototype with vial inside were sterilized by 50 kGy of gamma radiation. The microbial safety validation based on two-week testing confirmed successful sterilization of the sealing bags with vails. The analysis of physicochemical properties, namely mechanical properties, gel fraction studies revealed that sterilization did not cause any undesired changes in developed materials, compared to non-irradiated control samples.

Publisher

Trans Tech Publications, Ltd.

Subject

Mechanical Engineering,Mechanics of Materials,General Materials Science

Link

https://www.scientific.net/KEM.850.225.pdf

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