# US 8,541,195 B2 · Method for testing a sterilization packaging unit

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- Number: US 8,541,195 B2
- Document ID: US8541195B2
- Status: Granted
- Kind: B2
- Application number: 13/012,083
- Filed: 2011-01-24
- Published: 2011-05-19
- Granted: 2013-09-24
- Earliest claimed: 2011-01-24
- Applicants: Hartmut Dunkelberg
- Inventors: Hartmut Dunkelberg
- Web page: https://patentgrep.com/patent/US8541195B2

## CPC

- A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A testing unit and a method of testing a sterilization packaging unit for microbial contamination of sterilized objects after they have been sterilized are disclosed. The testing unit includes a dry matrix for accommodating a nutrient medium and a receptacle containing a liquid. By applying the liquid onto the matrix, the matrix is provided with a nutrient medium. In the method, the testing unit is inserted into the sterilization packaging unit which is sterilized and stored. At a desired point in time, the receptacle is opened in order to produce the nutrient medium in the matrix. After a possible multiplication of microbes on the matrix, an observation of microbes takes place. The invention also relates to a sterilization packaging unit which has a rigid outer casing and is suitable for the application of the method.

## Claims

### Claim 1

A method of testing a sterilization packaging unit provided for the sterilization of objects with regard to the efficacy of the sterilization packaging unit in preventing microbial recontamination of the sterilized objects after they have been sterilized, said method comprising:
inserting within said packaging unit a test unit, permeable to microbes, said test unit comprising a dry matrix adapted to support a complete nutrient medium and a sealed receptacle containing a liquid, said receptacle being operatively associated with said dry matrix;
sterilizing said packaging unit;
storing said packaging unit for a time period under ambient conditions;
opening said receptacle without opening the packaging unit and thereby allowing said liquid to contact said matrix, the combination of said liquid and said matrix providing said complete nutrient medium capable of supporting microbial reproduction on said matrix;
subjecting said packaging unit to conditions favorable for cultivation of microbes present on said matrix; and
observing microbes which have multiplied on said matrix.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said receptacle comprises an ampoule.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said ambient conditions and said time period are predetermined.

### Claim 4 (depends on 1)

The method according to claim 1, further comprising loading said packaging unit with objects to be sterilized.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said testing unit is inserted within said packaging unit in the absence of objects to be sterilized, wherein said packaging unit is sterilized and stored as part of a batch of sterilization objects and wherein the result of the testing is applied to the entire batch of sterilized objects.