# US 2019/0376108 A1 · Reference test body, use, test chamber, and method

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2019/0376108 A1
- Document ID: US20190376108A1
- Status: Published application
- Kind: A1
- Application number: 16/425,770
- Filed: 2019-05-29
- Published: 2019-12-12
- Earliest claimed: 2018-06-08
- Assignees: Aesculap AG
- Applicants: Aesculap AG
- Inventors: Selina Kammerer; Daniel Kiessling
- Web page: https://patentgrep.com/patent/US20190376108A1

## CPC

- C12Q 1/045: {Culture media therefor}
- C12Q 1/22: Testing for sterility conditions
- C12Q 1/18: Testing for antimicrobial activity of a material
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

A reference test body for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product, wherein the reference test body has a cavity, a nutrient medium, at least one opening, and at least one cover provided with a number of holes and covering the at least one opening. A constancy of test conditions can be monitored in this way. The invention further relates to an associated use, an associated test chamber, and an associated method.

## Claims

### Claim 16

A reference test body for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product, in particular under pressure variations, wherein the reference test body includes the following:
a cavity,
a nutrient medium located in the cavity and provided for germs,
at least one opening of the cavity, wherein the cavity is closed or closable except for the at least one opening, and
at least one cover, which closes the at least one opening and is perforated by a number of holes.

### Claim 17 (depends on 16)

The reference test body of claim 16, wherein the nutrient medium is liquid or solid.

### Claim 18 (depends on 16)

The reference test body of claim 16, wherein the at least one opening is arranged on a top face of the reference test body or on a side face of the reference test body.

### Claim 19 (depends on 16)

The reference test body of claim 16, wherein the cavity has no further inlet other than the at least one opening.

### Claim 20 (depends on 16)

The reference test body of claim 16, wherein the cavity has, in addition to the at least one opening, a closable inlet for the nutrient medium.

### Claim 21 (depends on 16)

The reference test body of claim 16, wherein the cavity is completely or partially surrounded by a transparent material, in particular a transparent plastic, preferably polystyrene or polyethylene terephthalate.

### Claim 22 (depends on 16)

The reference test body of claim 16, wherein the nutrient medium is arranged only at the bottom in the reference test body.

### Claim 23 (depends on 16)

The reference test body of claim 16, wherein the cavity is lined completely with the nutrient medium.

### Claim 24 (depends on 16)

The reference test body of claim 16, wherein the at least one cover is a small stainless steel plate.

### Claim 25 (depends on 16)

The reference test body of claim 16, wherein the at least one cover is perforated by means of laser machining.

### Claim 26 (depends on 16)

The reference test body of claim 16, wherein the cavity has the shape of a cylinder, in particular a circular cylinder, a cuboid, a cube, a sphere, a segment of a sphere or a bottle.

### Claim 27 (depends on 16)

The reference test body of claim 16, wherein the at least one opening is assigned a closure piece, by means of which the at least one opening together with the at least one cover is closable.

### Claim 28 (depends on 16)

A use of a reference test body according to claim 16, for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product.

### Claim 29 (depends on 16)

A test chamber for testing microbial barrier properties of at least one product, wherein a reference test body according to claim 16 is arranged in the test chamber.

### Claim 30 (depends on 16)

A method for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product, said method having the following steps:
introducing a reference test body according to claim 16 into a test chamber,
introducing germs into the test chamber,
generating conditions for the multiplication of germs that have penetrated the reference test body, for the purpose of culturing the germs inside or outside the reference test body,
counting the cell colonies that have grown, and
detecting the germs on the basis of the cell colonies that have grown.