New Standards and Developments in Insulin Syringe manufacturing andSterilization

سال انتشار: 1398
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 408

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شناسه ملی سند علمی:

MESMED09_093

تاریخ نمایه سازی: 11 اسفند 1398

چکیده مقاله:

Background And Objectives: ISO or the International Organization for Standardization is a worldwide federation of national standards bodies. InternationalStandard covers insulin syringes primarily intended for human use and providesperformance and testing necessities. Insulin syringes and needles are to be massproducedand sterilized in consensus with accrediting national or international codesof good industrial replication for medical devices. Serious problems can result if asyringe is used with a concentration of insulin that is various from the one for whichit was designed. It is favored that when more than one insulin condensation is in themarket, the new condensation is provided in a devoted to a delivery system thatmakes error-dosing minor presumably.Materials and Methods: It permits broader variation in design so as to not limitinnovation in technology or methods of packaging. Form and preparation are reliablewith other TC 84 International Standards, which are intended to be moreperformance-based than design-prescriptive. International Standard highlights theimportance of having separate syringes that are appropriately progressed and labeledfor only one attentiveness of insulin. Ethylene oxide (EtO) sterilization is compatiblewith a broad range of Syringe and medical device materials and therefore is widelyused by Syringe manufacturers and contract sterilizers but Gamma Irradiation is anespecially attractive method for the sterilization of Syringe.Results: This paper presents general requirements as to design rules. This paperretains a number of limits on requirements. International Standard does not onlyspecify materials to be used for the building and lubrication of sterile insulin syringesand needles. Their choice will depend on the manufacturer s exact syringe design theprocess of production and sterilization method. In affirmation that insulin in highercondensation in vials is available in some bazaars, new inventions are underdevelopment. This International Standard announces new color codes to differentiatesyringes for the new higher condensation of insulin. Gamma Irradiation is anespecially attractive method for the sterilization of medical devices and Syringe. Itresults in minimal or no rise in temperature, leaves no residue, and requires noquarantine time post processing.Conclusion: The sampling scheme for examination selected for this InternationalStandard is intended to investigate the design at a high confidence level. Thesampling scheme for inspection does not replace the more general manufacturingquality systems that perform in standards on systems, for example, the ISO 9000series and ISO 13485. Regulation on shift periods for employing the requirementsof this International Standard is given in ISO/TR 19244, expanded by ISO/TC 84.

کلیدواژه ها:

نویسندگان

Mostafa Soleimannejad

Department of Tissue Engineering, School of Advanced Technologies, Shahrekord University of Medical Sciences, Shahrekord, Iran

Gholamreza Mobini

Cellular & Molecular Research Center, Basic Health Sciences Institute, Shahrekord University of Medical Sciences (SkUMS), Shahrekord, Iran

Korosh Ashrafi

Department of Molecular Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran

Majid Validi

Department of Medical Laboratory Sciences, School of Allied Medical Sciences, Shahrekord University of Medical Sciences, Shahrekord, Iran