PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE
A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111),and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle ad...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111),and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle adaptor cap (12) has a rubber element (121) tightly sealing the orifice (113) of the tip (112) of thesyringe barrel (11) and the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) is sterilized by a first sterilizing comprising a mainstep of exposing the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 5 hours to about 60 hours at a relative humidity of about 40% to about 100% and at a temperature of about 30degrees to about 60degrees; (ii) filling a drug substance (14) through the open end (111) of the syringe barrel (11) into an interior of the syringe barre |
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