The Suitability of polyethylene terephthalate copolyester for radiation sterilized dry small volume parenterals

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Title: The Suitability of polyethylene terephthalate copolyester for radiation sterilized dry small volume parenterals
Author: Drucker, Steven M.
Abstract: Small volume parenterals (SVP) are typically terminally sterilized through autoclaving. This technique works when the containers are filled with a liquid. However, in the case of sterile powders, autoclaving is not a viable method nor is dry heat since most products can not withstand 2 50C for a half hour. Thus gamma irradiation may be an acceptable method to terminally sterilize this class of product. One of the drawbacks of gamma irradiation is that it will discolor glass which is currently the package material of choice due to superior barrier properties and relative inertness. This paper explores the possibility of packaging one product in a manner to accept gamma irradiation sterilization. In doing so, the various reguirements of SVP's are reviewed. The package used was a polyethylene terephthalate copolyester (PETG) vial that could withstand the required level of radiation without any discernible effects. The product was tested to determine what level of radiation it could withstand. Finally, product was irradiated and placed on stability to determine whether this package and process are suitable. The PETG vial was found to inadequately protect this product from moisture.
Record URI: http://hdl.handle.net/1850/11896
Date: 1993

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