METHODS FOR THE PREPARATION OF PRE-FILLED PLASTIC SYRINGES
A novel method for the preparation of a pre-filled plastic syringe, and preferably the preparation of a plastic syringe pre-filled with a diagnostic contrast agent wherein said syringe comprises as components a barrel, a tip seal capable of sealing the nozzle of the barrel and a piston capable of sliding in the barrel and sealing the open end of the barrel opposite the nozzle, comprising the steps of: (a) providing at least one component of said syringe which is molded under conditions which are substantially free of pyrogens and viable and non-viable particulates; and (b) filling and assembling said syringe.
1 . A method for the preparation of a pre-filled plastic syringe, comprising the steps of:
(a) providing at least one component of said syringe which is molded under conditions which are substantially free of pyrogens and viable and non-viable particulates; and
(b) filling and assembling said syringe.
2 . The method of claim 1 , wherein said syringe comprises as components a barrel, a tip seal capable of sealing the nozzle of the barrel and a piston capable of sliding in the barrel and sealing the open end of the barrel opposite the nozzle, and further, wherein said at least one component in step (a) includes one or more of said barrel, said tip seal and/or said piston.
3 . The method of claim 2 , wherein said at least one component of step (a) includes said barrel.
4 . The method of claim 3 , comprising the steps of:
(a) (i) providing a barrel which is molded under conditions which are substantially free of pyrogens and viable and non-viable particulates, and, optionally, providing a tip seal and/or a piston which is also molded under conditions which are substantially free of pyrogens and viable and non-viable particulates; and
(ii) maintaining said barrel and, optionally, said tip seal and/or piston, under clean conditions for use in step (b); and
(b) filling and assembling said syringe.
5 . The method of claim 4 , wherein said step (b), and optionally the following step (c), comprise the steps of:
(b) (i) attaching the tip seal to the nozzle end of said barrel;
(ii) filling the barrel and tip seal assembly with a liquid or semi-solid through the open end of the barrel, said open end being opposite said nozzle end of the barrel; and
(iii) assembling the piston in said open end of the barrel; and
(c) optionally, sterilizing the assembled syringe and its contents.
6 . The method of claim 2 , wherein said at least one component in step (a) is molded under conditions meeting or exceeding Class 10,000 conditions.
7 . The method of claim 6 , wherein said at least one component in step (a) is molded under conditions meeting or exceeding Class 1,000 conditions.
8 . The method of claim 7 , wherein said at least one component in step (a) is molded under conditions meeting or exceeding Class 100 conditions.
9 . The method of claim 2 , wherein said at least one component in step (a) is molded under conditions meeting or exceeding Class MCB-2 conditions.
10 . The method of claim 9 , wherein said at least one component in step (a) is molded under conditions meeting or exceeding Class MCB-1 conditions.
11 . The method of claim 3 , wherein a component of said syringe is treated by one or more of the following steps subsequent to molding:
(1) blowing the component with a gas;
(2) lubricating the component;
(3) washing the component with an inorganic and/or organic washing agent, and, optionally, rinsing the component;
(4) sterilizing the component; and/or
(5) preparing the component for storage or transport.
12 . The method of claim 11 , wherein one or more component(s) of the syringe are not molded under conditions which are substantially free of pyrogens and viable and non-viable particulates in accordance with step (a) and are, prior to assembly into said syringe, washed with an inorganic or organic washing agent and optionally rinsed, and/or sterilized.
13 . The method of claim 12 , wherein the one or more component(s) of the syringe which are molded under conditions which are substantially free of pyrogens and viable and non-viable particulates in accordance with step (a) are, prior to assembly into said syringe, not washed with an inorganic or organic washing agent and/or are not sterilized.
14 . The method of claim 13 , wherein said barrel is not water washed subsequent to molding and prior to assembly in said syringe.
15 . A method for molding a syringe component, comprising the step of molding said component under conditions which are substantially free of pyrogens and viable and non-viable particulates.
16 . The method of claim 15 , wherein said syringe component is a barrel, tip seal or piston.