Sterility Test Method for Petrolatum-Based Ophthalmic Ointments

Author:

Tsuji Kiyoshi1,Stapert E. M.1,Robertson John H.1,Waiyaki Peter M.1

Affiliation:

1. Control Analytical Research and Development, The Upjohn Company, Kalamazoo, Michigan 49001

Abstract

A sensitive sterility testing procedure for the detection of microbial contamination in petrolatum-based ointments is described. The method involves dissolving the ointment in filter-sterilized isopropyl myristate and filtering through a membrane filter. Improved sensitivity is obtained by blending the membrane in Trypticase Soy Broth before incubation. Filter-sterilized isopropyl myristate is shown to be less toxic to microorganisms than heat-sterilized isopropyl myristate. The isopropyl myristate method is more sensitive than the polyethylene glycol-ether method for the detection of microbial contamination.

Publisher

American Society for Microbiology

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Immunology and Microbiology,General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference10 articles.

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2. Sterile bacitracin-neomycin sulfate-polymyxin B sulfate ophthalmic ointment; sterile bacitracin-neomycin sulfate-polymyxin B sulfatehydrocortisone acetate ophthalmic ointment;Code;Title 21, Part 41e.,1968

3. Fine structure of Millipore filters;Friedman B.;Cell Biol.,1968

4. Application of statistics to problems in bacteriology. I. A means of determining bacterial population by the dilution method;Halvorson H. O.;J. Bacteriol.,1933

5. Kallings L. 0. 1965. Microbiological contamination of medical preparations. Report 1965 to the National Board of Health (Sweden).

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