Steris Inc.

Mesa Laboratories, Inc.

Other

Joseph P Dalmasso

Thaddeus Joseph Mielnik

David A Freeman

A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.

Biological indicator with integral package

A biological indicator including a plurality of metal carriers individually compartmentalized in a package, so that there are a plurality of different incremental population levels of a resistant test microorganism exposed at each site to test the efficacy of sterilization procedures. Preferably, the metal carriers have a surface which has been abraded, and the carriers are placed in a flat package having two parallel sides made of a material such as TYVEK.TM. that is permeable to, and unreactive with, the selected gas, such as H.sub.2 O.sub.2.

Biological indicator and method

The invention is directed to the sterilization of bone tissue for transplantation employing a hydrogen peroxide vapor sterilant. The bone tissue is exposed to the sterilant vapor at a pressure, temperature, and concentration, and for a period of time that is sufficient to sterilize the bone tissue, but insufficient to cause substantial physical, chemical and biological damage. The bone tissue is defatted, preferably demineralized, substantially free of moisture and blood, and may be lyophilized prior to sterilization.

Method of sterilization of bone tussue

A bacteria impermeable container or ampule (10) contains a liquid growth medium and a substrate-indicator complex. The complex includes a substrate component, e.g., starch, and an indicator molecule, e.g., a dye, a fluorescent molecule, or the like, which are tightly bound and complexed, but which are cleavable by a preselected enzyme. A sterilant passes over a carrier (20) for microorganisms which, upon germination, are capable of rapidly generating large quantities of the preselected enzyme. Following the sterilization process, the carrier is immersed in the liquid growth medium. Any viable surviving microorganisms grow, generating the preselected enzyme. The enzymes cleave the bound indicator molecule from the substrate, resulting in a measurable property change in a couple of hours. Typical property changes include fluorescence, a color change, a change in pH which triggers a pH indicator color change, and the like.

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Apex, NC, United States of America

Joseph P Dalmasso