Sterility of insulin in prefilled disposable syringes. 1990

E A Jackson, and B M Gallo
Department of Family Medicine, University of Connecticut School of Medicine, Farmington.

The sterility of insulin in prefilled syringes that had been prepared by visiting nurses in patients' homes and stored in their refrigerators for one month was studied. Twenty elderly diabetic patients requiring weekly home-nursing visits were enrolled in the study. At the initial study visit, a nurse filled 15 syringes with the type and amount of insulin being used by the patient. Seven syringes constituted the patient's supply for the coming week; the remaining eight syringes were appropriately labeled and placed in a separate part of the refrigerator. Upon returning to replenish the patient's insulin supply during each of the following four weeks, the nurse removed two of the stored syringes for subsequent culturing. The culture medium used was appropriate for bacteria that are usual skin flora and therefore are most likely to cause touch contamination during the syringe-filling process. Control-positive cultures were prepared by intentionally contaminating two vials of 0.9% sodium chloride injection and two vials of NPH insulin with Staph. aureus and Staph. epidermidis. Insulin from 159 syringes was tested, and no bacterial growth was detected by daily readings of cultures for one week. Of the contaminated control syringes, those containing sodium chloride injection produced positive cultures at each of the study weeks; the contaminated insulin samples, although positive at week 0, had become negative by week 3, confirming the bactericidal activity of one or more of the components of this insulin product. Prefilled insulin syringes that are prepared by nurses using good aseptic technique and are stored in the patient's refrigerator appear to remain sterile for up to one month after preparation.

UI MeSH Term Description Entries
D007328 Insulin A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1). Iletin,Insulin A Chain,Insulin B Chain,Insulin, Regular,Novolin,Sodium Insulin,Soluble Insulin,Chain, Insulin B,Insulin, Sodium,Insulin, Soluble,Regular Insulin
D004340 Drug Contamination The presence of organisms, or any foreign material that makes a drug preparation impure. Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D004356 Drug Storage The process of keeping pharmaceutical products in an appropriate location. Drug Storages,Storage, Drug,Storages, Drug
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D001431 Bacteriological Techniques Techniques used in studying bacteria. Bacteriologic Technic,Bacteriologic Technics,Bacteriologic Techniques,Bacteriological Technique,Technic, Bacteriological,Technics, Bacteriological,Technique, Bacteriological,Techniques, Bacteriological,Bacteriologic Technique,Bacteriological Technic,Bacteriological Technics,Technic, Bacteriologic,Technics, Bacteriologic,Technique, Bacteriologic,Techniques, Bacteriologic
D013242 Sterilization The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.
D013594 Syringes Instruments used for injecting or withdrawing fluids. (Stedman, 25th ed) Hypodermic Syringes,Syringe, Karman,Hypodermic Syringe,Karman Syringe,Syringe,Syringe, Hypodermic,Syringes, Hypodermic
D013696 Temperature The property of objects that determines the direction of heat flow when they are placed in direct thermal contact. The temperature is the energy of microscopic motions (vibrational and translational) of the particles of atoms. Temperatures

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