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Home Vasodialators Synergistic-preservative-systems-for-chemistry-reagents

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 Synergistic preservative systems for chemistry reagents

Details
Inventors: Voo, Liann; Tagliaferro, Dennis C.; Wilson, Joan B.;
Assignee: Ciba Corning Diagnostics Corp. (Medfield, MA)
Primary Examiner: Travers; Russell
Assistant Examiner:
Attorney, Agent or Firm: Morgenstern; Arthur S., Slepchuk, Jr.; Nicholas I., Roesler; Judith A.

A family of solutions that can be used to calibrate one or more electrochemical sensors has been developed. These systems can be used to determine analytes in biological fluids, such as whole blood, serum, plasma and urine. Since these reagents require preservatives in order to make their shelf life and use life commercially feasible, a system of preservatives which exhibits unexpected synergy in antimicrobial capabilities has been identified. The preferred preservative system includes a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one; 2-methyl-4-isothiazolin-3-one; and 1,3-bis-(hydroxymethyl)-5,5-dimethyl-2,4-imidazolidinedione.

DETAILED DESCRIPTION OF THE INVENTION In determining the antimicrobial system to use for critical care products, numerous factors had to be considered.
Although there are many microbicides available, these antimicrobial products must be carefully screened, because they are not equally effective against the variety of microorganisms that can grow in these products.
Furthermore, care must be taken to assure that the antimicrobials are not antagonistic to each other, will not interfere with the usefulness of the reagent it is used in (for example, interfere with the active ingredients in the product), nor interfere with any component of any other reagent it comes in contact with, nor will they migrate into the packaging materials they are stored in and thus not be available to preserve the chemical system, nor affect the performance of the instrument or its sensors, nor interfere with any other aspect of the system.
In addition, the antimicrobial agent(s) must be stable and effective for the shelf life of the product it is used in, both in original form of the reagent and, if applicable, in reconstituted form.
Furthermore, the antimicrobial must maintain effectiveness and stability in all forseeable environments, such as temperature and level of light, to which the reagent and its in-use concentration may be exposed.
If there are any degradation products that result from use of the antimicrobial, these must be innocuous to the system.
The sorts of microorganisms frequently encountered in the reagents include those that are water-borne or air-borne.
The genera include Staphylococcus, Streptococcus, Pseudomonas, Proteus and others.
In addition, various molds, yeasts and other microorganisms may infect the systems.
These microbes may also arise from contaminated raw materials, from equipment the product is compounded in, from contact with the instrument, from contact with the specimen and other sources.
Thus, to be truly effective, the antimicrobials must not merely inhibit the growth of microorganisms, but also must destroy any microorganisms which are introduced by any of the aforementioned factors and which interfere with the analysis



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