Detection system for microbial contamination in health-care products

• US 5,443,987 A
• Filed: 09/02/1993
• Issued: 08/22/1995
• Est. Priority Date: 09/02/1993
• Status: Expired due to Fees

• Current Assignee: Benedict T. Decicco, James K. Keeven
• Original Assignee: Benedict T. Decicco, James K. Keeven
• Inventors: Keeven, James K., DeCicco, Benedict T.
• Primary Examiner(s): Wityshyn, Michael G.
• Assistant Examiner(s): Williams, Jane
• Application Number:
  US08/115,543
• Time in Patent Office: 719 Days
• Field of Search: 435/4, 435/29, 435/31, 435/7.32, 435/968, 436/172, 436/201, 436/1, 514/844-848, 514/873, 514/900, 514/901, 514/902, 514/969, 514/827, 514/828, 514/880, 514/881, 514/912, 514/944, 514/945
• US Class Current: 435/4
• CPC Class Codes: C12Q 1/22 Testing for sterility conditions
• CPC Class Codes: Y10S 435/968 High energy substrates, e.g. fluorescent, chemiluminescent, radioactive

Abstract

An in-situ microbial contaminant detection system provides a chemical reagent within a liquid health care product or in close association with product packaging containing the health care product. The chemical reagent interacts with a variety of microbial contaminants or byproducts, such as enzymes and acids, of the microbial contaminants that are commonly found in health care products (e.g., P. cepacia, S. marcescens, E. cloacae, E. gergoviae, E. aerogenes, K. pneumoniae, and P. aeruginosa) and provides a visible indication of microbial contamination that can readily be discerned by a consumer. A color change is preferred.

Claims

1. A product, comprising:

a liquid health care product positioned within product packaging for containing said liquid health care product; and

means for sensing the presence of microbial contaminants selected from the group consisting of C. albicans, P. cepacia, S. marcescens, E. cloacae, E. gergoviae, E. aerogenes, K. pneumoniae, E. coli, S. aureus and P. aeruginosa within said liquid health care product and providing a visible indication of microbial contamination of the packaged product, said means for sensing being positioned inside said product packaging for containing said liquid health care product, said means for sensing responding to enzymes produced by said microbial contaminants and metabolic processes involving enzymes produced by said microbial contaminants.

2. The product of claim 1 wherein said means for sensing is a chemical reagent dissolved or dispersed within said health care product.

3. The product of claim 2 wherein said chemical reagent provides a color change as said visible indication of microbial contamination.

4. The product of claim 2 wherein said chemical reagent provides chemiluminescent, phosphorescent, or fluorescent light as said visible indication of microbial contamination.

5. The product of claim 1 wherein said means for sensing is a chemical reagent which is present in said health care product at a concentration less than 10% by weight.

6. The product of claim 1 wherein said means for sensing is a chemical reagent or mixture of two or more different chemical reagents which provide a visual indication for contamination of said liquid health care product by at least three different said microbial contaminants.

7. The product of claim 1 wherein said enzymes produced by said microbial contaminants are selected from the group consisting of glucosidases, esterases, sulfatases and phosphatases.

8. A product, comprising:

a liquid health care product positioned within product packaging for containing said liquid health care product; and

means for sensing the presence of microbial contaminants selected from the group consisting of C. albicans, P. cepacia, S. marcescens, E. cloacae, E. gergoviae, E. aerogenes, K. pneumoniae, E. coli, S. aureus, and P. aeruginosa within said liquid health care product wherein said means for sensing comprises a semi-permeable membrane filled with a chemical reagent which provides a visible indication of microbial contamination of the packaged-product, said semi-permeable membrane being positioned within said liquid health-care product inside said product packaging, said means for sensing responding to enzymes produced by said microbial contaminants and metabolic processes involving enzymes produced by said microbial contaminants.

9. The product of claim 8 wherein said semi-permeable membrane allows microbial contaminants or enzymes and other byproducts of microbial contamination to pass through, but prevents the passage of said chemical reagent.

10. The product of claim 8 wherein said semi-permeable membrane allows said chemical reagent to diffuse therethrough only after decomposition or other changes resulting from exposure to microbial contaminants or enzymes and other byproducts of microbial contamination.

11. The product of claim 8 wherein said chemical reagent provides a color change as said visible indication of microbial contamination.

12. The product of claim 8 wherein said chemical reagent provides chemiluminescent, phosphorescent, or fluorescent light as said visible indication of microbial contamination.

13. A product, comprising:

a liquid health care product positioned within product packaging for containing said liquid health care product; and

means for sensing the presence of microbial contaminants selected from the group consisting of C. albicans, P. cepacia, S. marcescens, E. cloacae, E. gergoviae, E. aerogenes, K. pneumoniae, E. coli, S. aureus, and P. aeruginosa within said liquid health care product wherein said means for sensing comprises a chemical reagent which provides a visible indication of microbial contamination of the packaged product and a means for immobilizing said chemical reagent on an inside surface of said packaging containing said health care product, said means for sensing responding to enzymes produced by said microbial contaminants and metabolic processes involving enzymes produced by said microbial contaminants.

14. The product of claim 13 wherein said means for immobilizing is a fibrous material.

15. The product of claim 14 wherein said fibrous material is positioned inside a cap for said packaging containing said health care product.

16. The product of claim 13 wherein said means for immobilizing is a stationary phase positioned on an inside surface of said packaging containing said health care product.

17. The product of claim 13 wherein said chemical reagent provides a color change as said visible indication of microbial contamination.

18. The product of claim 13 wherein said chemical reagent provides chemiluminescent, phosphorescent, or fluorescent light as said visible indication of microbial contamination.