Patent ID: 7416883
Filing Date: 2008-08-26
Classification: C12Q,G01N

Abstract:
1. A biological indicator for monitoring sterility; comprising a substrate; a surface layer containing functional groups residing on said substrate, said surface layer functional groups containing about 10% or less of any silicon linking atoms based upon the total amount of said surface layer functional groups; a plurality of microorganism indicators, said microorganisms comprising an endospore, a fungi, a mycobacteria, a vegetative bacteria, or a protozoa, or any combination thereof; a multifunctional crosslinking reagent having one functional end group covalently bonded to one of said surface layer functional groups and having another functional end group covalently bonded to one of said microorganism indicators so that a terminal and exposed microorganism indicator is present that is covalently bonded through said crosslinking agent to said surface layer, said surface layer having a plurality of said terminal and exposed microorganisms bound thereto that are capable of being sterilized by a sterilizing medium, said crosslinking reagent comprising N-succinimidyl 3-(2-pyridyldithio) propionate (SPDP); and wherein said plurality of said exposed and bound microorganism indicators covalently bonded to said substrate have a uniform distribution wherein the standard deviation thereof is about 50% or less based on one unit area of said surface layer as compared to another unit area of said surface layer.