EFFECT OF ETHYLENE OXIDE STERILIZATION ON PLASTISIZER MIGRATION AND MECHANICAL AND BLOOD PROPERTIES OF MEDICAL GRADE POLYVINYLE CHOLORIDE

Authors

DOI:

https://doi.org/10.31436/iiumej.v23i1.1769

Keywords:

Di (2-ethylhexyl) phthalate, Poly vinyl chloride, plasticizer, Blood bag,, Epoxidized soybean oil

Abstract

The use of phthalates as a plasticizer in plasticized polyvinyl chloride (PVC) always poses the threat of migration of phthalates into the environment through medical equipment. Phthalates can be used with natural-based plasticizers, such as Epoxidized soybean oil (ESBO) known as phthalate’s scavenger and PVC stabilizers. PVC formulations were characterized by different combinations of di (2-ethylhexyl) phthalate (DEHP) 30-40% with 5% ESBO. PVC flexibility increased significantly in the presence of ESBO, without a change in strength (tensile test). The decrease of the Tg temperature by adding ESBO in Differential Scanning Calorimetry indicated that ESBO preserved DEHP in the polymer. Also, it was shown that the sterilization process with Ethylene Oxide, similar to ESBO, decreased the Tg of polymer. DEHP migration was evaluated at a maximum level to the environment using the Gas Chromatography test. Samples containing ESBO showed less hemolysis.

ABSTRAK: Penggunaan phthalates sebagai plasticizer dalam plastik polyvinyl chloride (PVC) selalu menimbulkan ancaman penghijrahan phthalates ke alam sekitar melalui peralatan perubatan. Phthalates boleh digunakan dengan plasticizer berasaskan semula jadi, seperti minyak kacang soya Epoxidized (ESBO) yang dikenali sebagai pemulung phthalate dan penstabil PVC. Formulasi PVC dicirikan oleh kombinasi yang berbeza di (2-ethylhexyl) phthalate (DEHP) 30-40% dengan 5% ESBO. Fleksibiliti PVC meningkat dengan ketara di hadapan ESBO, tanpa perubahan kekuatan (ujian tegangan). Penurunan suhu Tg dengan menambahkan ESBO dalam Calorimetri Pengimbasan Berbeza menunjukkan bahawa ESBO mengekalkan DEHP dalam polimer. Juga, ditunjukkan bahawa proses pensterilan dengan Etilena Oksida, serupa dengan ESBO, menurunkan Tg polimer. Penghijrahan DEHP dinilai pada tahap maksimum ke lingkungan menggunakan uji Kromatografi Gas. Sampel yang mengandungi ESBO menunjukkan kurang hemolisis. 

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

References

Van der Meer PF, Reesink HW, Panzer S, Wong J, Ismay S, Keller A, (2014) Should DEHP be eliminated in blood bags?. Vox Sang 106(2):176-95,doi: 10.1111/vox.12099. DOI: https://doi.org/10.1111/vox.12099

Dumont LJ, Baker S, Dumont DF, (2012)., Exploratory in vitro study of red blood cell storage containers formulated with an alternative plasticizer. Transfusion 20(7):1439-45, doi:10.1111/j.1537-2995.2011.03506.x. DOI: https://doi.org/10.1111/j.1537-2995.2011.03506.x

Chiellini F, Ferri M, Morelli A, Dipaola L, Latini G. (2013) Perspectives on alternatives to phthalate plasticized poly(vinyl chloride) in medical devices applications. Prog in Polym Science 38(7): 1067-1088, doi:10.1016/j.progpolymsci.2013.03.001. DOI: https://doi.org/10.1016/j.progpolymsci.2013.03.001

Hakkarainen M, (2003) New PVC materials for medical applications—the release profile of PVC/polycaprolactone–polycarbonate aged in aqueous environments. Polym Degrad Stab 80(3):451-458, doi:10.1016/S0141-3910(03)00029-6. DOI: https://doi.org/10.1016/S0141-3910(03)00029-6

Coltro L, Pitta JB, Madaleno E, (2013) Performance evaluation of new plasticizers for stretch PVC films. Polym Test 32(2):272-278, doi:10.1016/j.polymertesting.2012.11.009. DOI: https://doi.org/10.1016/j.polymertesting.2012.11.009

Radaniel T, Genay S, Simon N, et al., (2014) Quantification of five plasticizers used in PVC tubing through high performance liquid chromatographic-UV detection. J Chromatogr B Analyt Technol Biomed Life Sci 965:158-63, doi: 10.1016/j.jchromb.2014.06.027. DOI: https://doi.org/10.1016/j.jchromb.2014.06.027

Lamba NM, Courtney JM, Gaylor JD, Lowe GD. (2000)In vitro investigation of the blood response to medical grade PVC and the effect of heparin on the blood response. Biomater 21(1):89-96, doi:10.1016/S0142-9612(99)00145-3. DOI: https://doi.org/10.1016/S0142-9612(99)00145-3

Labed V, Obeid H, Ressayre K. (2013) Effect of relative humidity and temperature on PVC degradation under gamma irradiation: Evolution of HCl production Yields. Radiat Phys Chem 84:26-29, doi:10.1016/j.radphyschem.2012.06.052. DOI: https://doi.org/10.1016/j.radphyschem.2012.06.052

Haishima Y, Matsuda R, Hayashi Y, Hasegawa C, Yagami T, Tsuchiya T. (2004) Risk assessment of di(2-ethylhexyl)phthalate released from PVC blood circuits during hemodialysis and pump-oxygenation therapy. Int J Pharm 274(1-2):119-29, doi:10.1016/j.ijpharm.2004.01.009. DOI: https://doi.org/10.1016/j.ijpharm.2004.01.009

Al Salloum H, Saunier J. Tfayli A. Yagoubi N. (2016) Studying DEHP migration in plasticized PVC used for blood bags by coupling Raman confocal microscopy to UV spectroscopy. Mater Sci Eng C Mater Biol Appl 61:56-62, doi: 10.1016/j.msec.2015.12.008. DOI: https://doi.org/10.1016/j.msec.2015.12.008

Khorasani MT, Mirzadeh H. (2007) Effect of oxygen plasma treatment on surface charge and wettability of PVC blood bag—In vitro assay. Radiat Phys Chem 76(6):1011-1016, doi:10.1016/j.radphyschem.2006.10.002. DOI: https://doi.org/10.1016/j.radphyschem.2006.10.002

Mankidy R., Wiseman S. Ma H, Giesy JP. (2013) Biological impact of phthalates. Toxicol Lett 217(1): 50-8, doi:10.1016/j.toxlet.2012.11.025. DOI: https://doi.org/10.1016/j.toxlet.2012.11.025

Wang Q, Storm BK. (2005) Separation and analysis of low molecular weight plasticizers in poly(vinyl chloride) tubes. Polym Test 24(3):290-300, doi:10.1016/j.polymertesting.2004.12.002. DOI: https://doi.org/10.1016/j.polymertesting.2004.12.002

Haishima Y, Seshimo F, Higuch T, (2005) Development of a simple method for predicting the levels of di(2-ethylhexyl) phthalate migrated from PVC medical devices into pharmaceutical solutions. Int J Pharm 298(1): 126-42, doi: 10.1016/j.ijpharm.2005.04.009. DOI: https://doi.org/10.1016/j.ijpharm.2005.04.009

Zygoura PD, Paleologos EK, Kontominas MG. (2011) Migration levels of PVC plasticisers: Effect of ionising radiation treatment. Food Chem 128(1):106-13, doi: 10.1016/j.foodchem.2011.03.002. DOI: https://doi.org/10.1016/j.foodchem.2011.03.002

Burgos N, Jiménez A. (2009) Degradation of poly(vinyl chloride) plasticized with non-phthalate plasticizers under sterilization conditions. Polym Degrad Stab 94(9):1473-1478, doi:10.1016/j.polymdegradstab.2009.05.004. DOI: https://doi.org/10.1016/j.polymdegradstab.2009.05.004

Fankhauser-Noti A, Fiselier K, Biedermann-Brem S, Grob, K. (2006) Assessment of epoxidized soy bean oil (ESBO) migrating into foods: comparison with ESBO-like epoxy fatty acids in our normal diet. Food Chem Toxicol 44(8):1279-86, doi: 10.1016/j.fct.2006.02.005. DOI: https://doi.org/10.1016/j.fct.2006.02.005

Karmalm P, Hjertberg T, Jansson A, Dahl R. (2009) Thermal stability of poly(vinyl chloride) with epoxidised soybean oil as primary plasticizer. Polym Degrad Stab 94(12):2275-2281, doi:10.1016/j.polymdegradstab.2009.07.019. DOI: https://doi.org/10.1016/j.polymdegradstab.2009.07.019

Yu BY, Lee AR, Kwak SY. (2012) Gelation/fusion behavior of PVC plastisol with a cyclodextrin derivative and an anti-migration plasticizer in flexible PVC. Eur Polym J 48(5):885-895, doi:10.1016/j.eurpolymj.2012.02.008. DOI: https://doi.org/10.1016/j.eurpolymj.2012.02.008

Bueno-Ferrer C, Garrigós MC, Jiménez A. (2010) Characterization and thermal stability of poly(vinyl chloride) plasticized with epoxidized soybean oil for food packaging. Polym Degrad Stab 95(11):2207-2212, doi:10.1016/j.polymdegradstab.2010.01.027. DOI: https://doi.org/10.1016/j.polymdegradstab.2010.01.027

Hammarling L, Gustavsson H. Svensson K, Karlsson S, Oskarsson A. (1998) Migration of epoxidized soya bean oil from plasticized PVC gaskets into baby food. Food Addit Contam 15(2):203-8, doi: 10.1080/02652039809374631. DOI: https://doi.org/10.1080/02652039809374631

SANCO D. European Commission, Health & Consumer Protection Directorate-General. Opinion on Medical Devices Containing DEHP Plasticised PVC 2002, doi: 10.2772/45179.

Sunny MC, Ramesh P, Mohanan PV, George KE. (2010) Metallocene based polyolefin: a potential candidate for the replacement of flexible poly (vinyl chloride) in the medical field. Polym for Advanced Technologies 21(9):621-631, doi:10.1002/pat.1475. DOI: https://doi.org/10.1002/pat.1475

Al Salloum H, Saunier J, Aymes-Chodur C, Barakat H, Yagoubi N. (2015) Impact of the nature and concentration of plasticizers on the ability of PVC to sorb drug. Int J Pharm 496(2):664-75, doi:10.1016/j.ijpharm.2015.11.004. DOI: https://doi.org/10.1016/j.ijpharm.2015.11.004

Sarath Josh MK, Pradeep S. Balachandran S, Sudha Devi R, Vijayalakshmi Amma KS, Benjamin S. (2012). Temperature- and solvent-dependent migrations of di(2-ethylhexyl) phthalate, the hazardous plasticizer from commercial PVC blood storage bag. J Polym Res 19(7), doi:10.1007/s10965-012-9915-4. DOI: https://doi.org/10.1007/s10965-012-9915-4

Jérémy P et al (2019). New SPE-LC-MS/MS method for the simultaneous determination in urine of 22 metabolites of DEHP and alternative plasticizers from PVC medical devices, talanta, 198:377-389 DOI: https://doi.org/10.1016/j.talanta.2019.01.115

Haishima Y, Kawakami T, Hasegawa C, Tanoue A, Yuba T, Isama K, Matsuoka A, Niimi S. (2014). Screening study on hemolysis suppression effect of an alternative plasticizer for the development of a novel blood container made of polyvinyl chloride. J Biomed Mater Res B Appl Biomater 102(4):721-8, doi: 10.1002/jbm.b.33052. DOI: https://doi.org/10.1002/jbm.b.33052

Estep TN, Pedersen RA, Miller TJ, Stupar KR. (1984) Characterization of erythrocyte quality during the refrigerated storage of whole blood containing di-(2-ethylhexyl) phthalate. Blood 64(6): 1270-6, doi:10.1182/blood.V64.6.1270.1270 DOI: https://doi.org/10.1182/blood.V64.6.1270.1270

Amandine D et al. (2019). Simultaneous determination of di(2-ethylhexyl) phthalate and diisononylcyclohexane-1,2-dicarboxylate and their monoester metabolites in four labile blood products by liquid chromatography tandem mass spectrometry, Journal of Pharmaceutical and Biomedical Analysis, 181:1-11, doi:10.1016/j.jpba.2019.113063. DOI: https://doi.org/10.1016/j.jpba.2019.113063

Downloads

Published

2022-01-04

How to Cite

Poostchi, M., & Bagheri, H. (2022). EFFECT OF ETHYLENE OXIDE STERILIZATION ON PLASTISIZER MIGRATION AND MECHANICAL AND BLOOD PROPERTIES OF MEDICAL GRADE POLYVINYLE CHOLORIDE. IIUM Engineering Journal, 23(1), 282–293. https://doi.org/10.31436/iiumej.v23i1.1769

Issue

Section

Materials and Manufacturing Engineering