# US 4,397,945 A · Test method and apparatus for the presence of microorganism in syringe

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- Number: US 4,397,945 A
- Document ID: US4397945A
- Status: Granted
- Kind: A
- Application number: 06/272,226
- Filed: 1981-06-10
- Granted: 1983-08-09
- Earliest claimed: 1981-06-10
- Assignees: Millipore Corporation
- Inventors: Jean Lemonnier
- Web page: https://patentgrep.com/patent/US4397945A

## CPC

- A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00)
- C12Q 1/22: Testing for sterility conditions
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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 method and apparatus for testing the sterility of the contents of a syringe and the sterility of the internal and external surfaces of a needle connected to the syringe or the contents of a syringe and the sterility of the tip of the syringe nipple (in those cases where the syringe is not fitted with a needle). The needle is inserted into a tube by penetrating a small hole in an adaptor connected to one end of the tube. The adaptor includes a recess so that the syringe and needle can be stably positioned relative to the tube. The tube includes a liquid outlet adjacent to the adaptor so that the liquid contents of the syringe exiting from the needle washes the outside surface of the needle or the tip of the syringe needle before leaving the tube. The liquid leaving the tube is cultured and incubated to determine whether microorganisms are present therein.

## Claims

### Claim 1

Apparatus for testing the sterility of the contents of a syringe and of a needle attached to said syringe which comprises a tube, an adaptor means attached to a first end of said tube, said adaptor means including a small hole, a spout and a recess, said recess adapted to receive and retain said syringe, means for connecting a second end of said tube to a source of a sterile solution in order to establish fluid communication between said tube and said sterile solution source, means to remove the liquid contents of said syringe from said tube through said spout and to direct said liquid into at least one canister adapted to filter said liquid and to grow microorganisms in said liquid in the absence of microorganisms in the surrounding atmosphere.

### Claim 2 (depends on 1)

The apparatus of claim 1 where in a needle attached to said syringe is positioned through said small hole and axially within said tube, the outer surface of said needle being between about 0.5 mm and 2 mm from the inner surface of said tube.

### Claim 3 (depends on 1)

The apparatus of claim 1 including means to direct liquid from said tube to a plurality of sterile containers, each of said sterile containers including filter means for filtering microorganisms from said liquid.

### Claim 4

The process for testing the sterility of liquid contents of a syringe, said syringe having a needle attached thereto which comprises forcing said liquid contents from said syringe, through said needle and into a sterile tube, said tube having an inner surface spaced apart from the outer surface of said needle a distance less than about 3 mm, passing the liquid exiting from said needle along the outer surface of said needle within the tube, removing said liquid from said tube by exit means positioned adjacent the point of entry of said needle in said tube, passing said liquid through a filter under sterile conditions, contacting said filter with a growth medium incubating said growth medium and filtered material under sterile conditions and observing any change in said growth medium in order to determine the presence of a microorganism in said liquid or on said needle.

### Claim 5 (depends on 4)

The process of claim 4 wherein said growth medium is a thioglycollate solution.

### Claim 6 (depends on 4)

The process of claim 4 wherein said growth medium is soybean-casein digest medium.

### Claim 7 (depends on 4)

The process of claim 4 wherein said growth medium is Sabouraud medium.

### Claim 8 (depends on 4)

The process of claim 4 wherein said liquid exiting from said tube is formed into aliquots and wherein each aliquot is passed through a separate filter under sterile conditions and each of said filters is contacted with a growth medium and incubated.