Method for the preparation of pre-filled plastic syringes
View Patent ↗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 including a plurality of components, comprising:
(a) providing at least two first components of said syringe which are molded under first conditions which are substantially free of pyrogens and viable and non-viable particulates, said conditions, with respect to particulates, meeting a cleanliness level of about Class 100 and, with respect to microbes, meeting (i) a cleanliness level of Class MCB-3 and (ii) a microbial level of gram negative microorganisms of less than 1 colony forming unit (cfu) per cubic foot of air;
(b) providing at least one other component of said syringe which is molded under second conditions which are substantially free of particulates, said conditions, with respect to particulates, meeting a cleanliness level of about Class 100,000; and
(c) filling and assembling said syringe;
wherein the first components are maintained under said first conditions for use in (c).
2. The method of claim 1 , wherein said two first syringe components are a barrel and a piston component, and said one other component is a tip seal.
3. The method of claim 1 , wherein at least one of said two first syringe components is injection molded.
4. The method of claim 1 , wherein an elevated temperature and/or pressure is employed during said molding of said two first components.
5. The method of claim 1 , wherein an elevated temperature and/or pressure is employed during said molding of said other component.