Method for the preparation of pre-filled plastic syringes
AssigneeBracco International B.V.
InventorsGayle Heffernan, Allen Welsher
Life of this patent
Estimating the term…
Abstract
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 articulates; and (b) filling and assembling said syringe.
Claims7
A method for the preparation of a pre-filled plastic syringe having a plurality of components including a barrel, comprising the steps of:
- (a) providing at least said barrel molded under conditions which are substantially free of pyrogens and viable and non-viable particulates, said conditions meeting a cleanliness level of about Class 100;
- and
- (b) filling and assembling said syringe.
A method for the preparation of a pre-filled plastic syringe including a barrel, a tip seal and a piston, comprising the steps of:
- (a) providing a barrel including an open end and a nozzle end opposite the open end which is molded under conditions which are substantially free of pyrogens and viable and non-viable particulates, said conditions meeting a cleanliness level of about Class 100;
- (b) maintaining said barrel under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- (c) providing the tip seal and piston under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- and
- (d) filling and assembling the syringe under conditions meeting a cleanliness level of about Class 100.
A method for the preparation of a pre-filled plastic syringe including a barrel, a tip seal and a piston, comprising the steps of:
- (a) providing a barrel including an open end and a nozzle end opposite the open end which is molded under conditions which are substantially free of pyrogens and viable and non-viable particulates, said conditions meeting a cleanliness level of about Class 100;
- (b) maintaining said barrel under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- (c) providing the tip seal and piston under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- (d) filling and assembling the syringe under conditions meeting a cleanliness level of about Class 100, wherein:
- (i) said tip seal is attached to the nozzle end of said barrel;
- (ii) said barrel and tip seal assembly is filled through said open end of said barrel;
- and
- (iii) said piston is assembled in said open end of said barrel.
A method for the preparation of a pre-filled plastic syringe including a barrel, a tip seal and a piston, comprising the steps of:
- (a) (i) providing a plastic barrel including an open end and a nozzle end opposite the open end which is molded under conditions which are substantially free of pyrogens and viable and non-viable particulates, said conditions meeting a cleanliness level of about Class 100;
- (ii) maintaining said barrel under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- (b) (i) providing a rubber tip seal which is formed under conditions less clean than Class 100;
- (ii) washing said tip seal under conditions meeting a cleanliness level of about Class 100;
- (iii) maintaining said tip seal under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- (c) (i) providing a piston having a rubber cover which is formed under conditions less clean than Class 100;
- (ii) washing said rubber cover under conditions meeting a cleanliness level of about Class 100;
- (v) maintaining said piston under conditions meeting a cleanliness level of about Class 100 for filling and assembling the syringe;
- (d) filling and assembling the syringe under conditions meeting a cleanliness level of about Class 100, wherein:
- (i) said tip seal is attached to the nozzle end of said barrel;
- (ii) the barrel and tip seal assembly is filled through the open end of said barrel;
- and
- (iii) said piston is assembled in the open end of said barrel.
Dependencies are inferred from the claim text.