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Research Papers

The Effect of Different Sterilization Methods on Polypropylene Syringes

[+] Author and Article Information
N. Selcan Turker

Department of Radiopharmacy,
Faculty of Pharmacy,
Hacettepe University,
Sıhhiye 06100, Ankara, Turkey;
Harvard Medical School,
MGH Athinoula A. Martinos Center for
Biomedical Imaging,
Boston, MA 02129

A. Yekta Özer

Department of Radiopharmacy,
Faculty of Pharmacy,
Hacettepe University,
Sıhhiye 06100, Ankara, Turkey
e-mail: ayozer@hacettepe.edu.tr

Burak Kutlu, Rahime Nohutcu

Department of Periodontology,
Faculty of Dentistry,
Hacettepe University,
Sıhhiye 06100, Ankara, Turkey

Seyda Colak

Department of Physics Engineering,
Faculty of Engineering,
Hacettepe University,
Sıhhiye 06100, Ankara, Turkey

Melike Ekizoglu, Meral Özalp

Department of Pharmaceutical Microbiology,
Faculty of Pharmacy,
Hacettepe University,
Sıhhiye 06100, Ankara, Turkey

1Corresponding author.

Manuscript received July 11, 2017; final manuscript received January 31, 2018; published online April 5, 2018. Assoc. Editor: Xiaoming He.

J. Med. Devices 12(2), 021005 (Apr 05, 2018) (11 pages) Paper No: MED-17-1264; doi: 10.1115/1.4039434 History: Received July 11, 2017; Revised January 31, 2018

This presents the influence of gamma irradiation on Pharmacopeia specifications, mechanical and flow parameters of polypropylene (PP) syringes. There has been significant progress in the terminal sterilization of single-use, disposable medical devices with gamma radiation sterilization due to the growing awareness of toxic residues during the ethylene oxide (EtO) sterilization. PP is a widely used polymer for the production of syringes because of its excellent mechanical and thermal properties and has expanded continuously over the last decade. Although 25 kGy was generally recommended for the gamma radiation sterilization of medical products, this radiation dose is high enough to produce substantial damage. Electron spin resonance (ESR) characteristics of irradiated syringes were also studied at normal (25 °C, 60% relative humidity) and accelerated (40 °C, 75% relative humidity) stability test conditions. It was found that the chemical and radiolytic changes and sterility assurance levels (SAL) after gamma radiation sterilization were different in PP syringes. It was shown that for two commercial syringes, E1 and E3, a SAL of 10−4 could be attained with only 10 kGy, with there being less detrimental radiation effects on E1. The differences in the radiosensitivity of the propylene syringes could be due to the different formulations and manufacturing processes. The results indicated that a commercial syringe, identified as E1 could be safely sterilized with gamma irradiation as the radicals decay over a period of days under normal conditions and quenched much faster under stability conditions. Furthermore, ESR technique could be used successfully in monitoring the radiosterilization of this material. Additionally, the confirmation and validation of the SAL doses which are below 25 kGy, will decrease the time and cost of the sterilization with less damaging effects of ionizing irradiation.

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Figures

Grahic Jump Location
Fig. 3

Changes in elastic modulus of PP syringes gamma irradiated at 0, 5, 10, 25, and 50 kGy

Grahic Jump Location
Fig. 2

Changes in elongation at break of PP syringes gamma irradiated at 5, 10, 25, and 50 kGy

Grahic Jump Location
Fig. 1

Mechanic behaviors of E1, E2, and E3 syringes irradiated at 5, 10, 25, and 50 kGy

Grahic Jump Location
Fig. 5

Room temperature ESR spectra of E1, E2, and E3 irradiated at different radiation doses: (a) 5 kGy, (b) 10 kGy, (c) 25 kGy, and (d) 50 kGy. Arrow indicates the position of DPPH line.

Grahic Jump Location
Fig. 4

Dose survival curves of E1, E2, and E3 syringes irradiated at different radiation doses (1, 5, and 10 kGy)

Grahic Jump Location
Fig. 6

Variations of ESR peak-heights versus applied microwave power (P) for the E1, E2, and E3 samples: (a) irradiated at a dose of 50 kGy at room temperature and (b) 25 kGy at 130 K

Grahic Jump Location
Fig. 7

(a) Variations of ESR resonance peak intensities of E1, E2, and E3 samples with absorbed radiation dose and (b) variations in area under curve values of irradiated E1, E2, and E3 samples in response to radiation dose

Grahic Jump Location
Fig. 8

(a) Variations in the peak heights of the E1 and E2 samples irradiated at a dose of 25 kGy stored at (a) normal and (b) stability conditions

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