Patent ID: 7509784
Filing Date: 2009-03-31
Classification: A61M,B65B

Abstract:
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).