# US 11,027,869 B2 · Method for separate sterilization and aseptic assembly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,869 B2 - Document ID: US11027869B2 - Status: Granted - Kind: B2 - Application number: 15/982,629 - Filed: 2018-05-17 - Published: 2018-09-20 - Granted: 2021-06-08 - Earliest claimed: 2015-11-19 - Assignees: Roche Diabetes Care, Inc. - Applicants: Roche Diabetes Care, Inc. - Inventors: Herbert Harttig - Web page: https://patentgrep.com/patent/US11027869B2 ## CPC - B65B 55/02: Sterilising, e.g. of complete packages - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation - A61L 2/206: Ethylene oxide - A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles} - A61M 5/1413: {Modular systems comprising interconnecting elements} - A61B 2562/242: Packaging, i.e. for packaging the sensor or apparatus before use - A61L 2/04: Heat (radiation A61L2/08) - A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps - A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail} - A61L 2202/181: Flexible packaging means, e.g. permeable membranes, paper - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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) - 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)} ## Abstract Disclosed is an inventive method for an aseptic assembly of a multi-component medical device. In this method a first component of the medical device is provided in a first container and a second component of the medical device is provided in a second container. Each of the first and second separated containers have a rupturable portion. The first component in the first container is sterilized using a first sterilization technique and the second component in the second container is sterilized using a second sterilization technique. The first and second containers are joined while arranging the rupturable portions in an overlapping configuration which is aseptically sealed against the surroundings. Finally, one of the components is transferred through the rupturable portions and the components are aseptically assembled to form the medical device as a sterile package. ## Claims ### Claim 1 A method for an aseptic assembly of a multi-component medical device, comprising: a) providing a first component of the medical device in a first container having a first rupturable portion; b) providing a second component of the medical device in a second container having a second rupturable portion; c) sterilizing the first component in the first container using a first sterilization technique and sterilizing the second component in the second container using a second sterilization technique, wherein the first and second sterilization techniques are different and are selected from the group consisting of gas sterilization, irradiation sterilization, and thermal sterilization; d) joining the first and second containers to form a sterile kit wherein the first and second rupturable portions are arranged in an overlapping configuration which is aseptically sealed against the surroundings; e) transferring one of the components through the first and second rupturable portions and aseptically assembling the components to form the medical device as a sterile package; and wherein step e is performed within an interior space enclosed by the first and second containers and wherein the method further comprises removing the medical device assembled during step e from the first and second containers before using the medical device. ### Claim 2 (depends on 1) The method according to claim 1, wherein one of the containers has a gas-permeable and aseptically sealed membrane, and wherein a sterilization gas is introduced and released through the membrane. ### Claim 3 (depends on 2) The method according to claim 2, wherein the sterilization gas is introduced and released through the membrane by a pressure alternating procedure. ### Claim 4 (depends on 1) The method according to claim 1, wherein one of the first and second sterilization techniques is gas sterilization with ethylene oxide gas. ### Claim 5 (depends on 4) The method of claim 4, wherein one of the containers has a gas-permeable and aseptically sealing membrane, and wherein the ethylene oxide gas is introduced and released through the membrane. ### Claim 6 (depends on 1) The method according to claim 1, wherein one of the first and second sterilization techniques uses an electron beam. ### Claim 7 (depends on 1) The method according to claim 1, further comprising arranging a plurality of first or second containers including respective components in a sterile-tight outer covering before the sterilizing step. ### Claim 8 (depends on 1) The method according to claim 1, wherein step d is performed in a sterile environment and step e is performed after removing the sterile kit from the sterile environment. ### Claim 9 (depends on 1) The method according to claim 1, wherein at least one of the first and second containers has an adhesive portion, and wherein the containers are adhered to each other using the adhesive portion. ### Claim 10 (depends on 1) The method according to claim 1, further comprising forming an aseptic seal around the rupturable portions by bonding together sealing portions of the first and second containers. ### Claim 11 (depends on 1) The method according to claim 1, wherein the step of transferring one of the components includes rupturing both the first and second rupturable portions. ### Claim 12 (depends on 1) The method according to claim 1, wherein the component to be transferred is used to rupture the first and second rupturable portions. ### Claim 13 (depends on 1) The method according to claim 1, further comprising manipulating at least one of the first and second components by using a handling aid provided within the containers. ### Claim 14 (depends on 1) The method according to claim 1, further comprising providing one of the first and second containers as a flexible bag or bellow and compressing the flexible bag or bellow to move the component included therein. ### Claim 15 (depends on 1) The method according to claim 1, wherein at least one of the first and second containers has a flexible wall, and wherein at least one of the first and second components is manipulated through the flexible wall to form the medical device. ### Claim 16 (depends on 1) The method according to claim 1, further comprising forming at least a part of the containers from a plastic material. ### Claim 17 (depends on 16) The method according to claim 16, wherein the forming of the at least a part of the containers comprises injection molding, blow molding or deep drawing. ### Claim 18 (depends on 1) The method according to claim 1, further comprising forming at least one of the first and second rupturable portions from a thin flexible sheet of material. ### Claim 19 (depends on 18) The method according to claim 18, wherein the thin flexible sheet of material is a metal foil. ### Claim 20 (depends on 1) The method according to claim 1, wherein the multi-component medical device is a skin mountable sensor device. ### Claim 21 An aseptic kit for a multi-component medical device, comprising: a first component of the medical device in a first container having a first rupturable portion and a second component of the medical device in a second container having a second rupturable portion, wherein the first component is maintained sterile by a first sterilization technique and the second component is maintained sterile by a second sterilization technique different than the first sterilization technique, the first and second sterilization techniques being selected from the group consisting of gas sterilization, irradiation sterilization and thermal sterilization; wherein the first and second containers are connected to each other such that the first and second rupturable portions are arranged in an overlapping configuration and wherein the first and second containers are bonded to each other to form an aseptic seal around the first and second rupturable portions; and wherein one of the first and second components is configured to be transferred through the first and second rupturable portions to assemble the medical device; and wherein the first rupturable portion is disposed on a lid attached to the first container, the lid being configured such that detachment of the lid from the first container allows removal of the medical device from the first and second containers before use of the medical device. ### Claim 22 (depends on 21) The aseptic kit of claim 21, wherein the multi-component medical device is a skin mountable sensor device.