New Standards and Developments in Insulin Syringe manufacturing and Sterilization

Publish Year: 1398
نوع سند: مقاله کنفرانسی
زبان: English
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MESMED09_008

تاریخ نمایه سازی: 11 اسفند 1398

Abstract:

Background And Objectives: ISO or the International Organization for Standardization is a worldwide federation of national standards bodies. International Standard covers insulin syringes primarily intended for human use and provides performance and testing necessities. Insulin syringes and needles are to be massproduced and sterilized in consensus with accrediting national or international codes of good industrial replication for medical devices. Serious problems can result if a syringe 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 the market, the new condensation is provided in a devoted to a delivery system that makes error-dosing minor presumably.Materials and Methods: It permits broader variation in design so as to not limit innovation in technology or methods of packaging. Form and preparation are reliable with other TC 84 International Standards, which are intended to be more performance-based than design-prescriptive. International Standard highlights the importance of having separate syringes that are appropriately progressed and labeled for only one attentiveness of insulin. Ethylene oxide (EtO) sterilization is compatible with a broad range of Syringe and medical device materials and therefore is widely used by Syringe manufacturers and contract sterilizers but Gamma Irradiation is an especially attractive method for the sterilization of Syringe. Results: This paper presents general requirements as to design rules. This paper retains a number of limits on requirements. International Standard does not only specify materials to be used for the building and lubrication of sterile insulin syringes and needles. Their choice will depend on the manufacturer s exact syringe design the process of production and sterilization method. In affirmation that insulin in highercondensation in vials is available in some bazaars, new inventions are under development. This International Standard announces new color codes to differentiate syringes for the new higher condensation of insulin. Gamma Irradiation is an especially attractive method for the sterilization of medical devices and Syringe. It results in minimal or no rise in temperature, leaves no residue, and requires no quarantine time post processing.Conclusion: The sampling scheme for examination selected for this International Standard is intended to investigate the design at a high confidence level. The sampling scheme for inspection does not replace the more general manufacturing quality systems that perform in standards on systems, for example, the ISO 9000 series and ISO 13485. Regulation on shift periods for employing the requirements of this International Standard is given in ISO/TR 19244, expanded by ISO/TC 84.

Authors

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