Aseptic assembling of pharmaceutical containers
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61J-001/10
A61J-001/14
B65D-077/00
A61J-001/20
B65B-003/00
B65B-005/06
B65B-007/02
B65B-055/02
A61J-001/16
B65D-073/00
B65D-081/18
A61M-005/00
출원번호
US-0868576
(2015-09-29)
등록번호
US-9456956
(2016-10-04)
발명자
/ 주소
Webster, Eric
Zigler, Steven
출원인 / 주소
Siemens Medical Solutions USA, Inc.
인용정보
피인용 횟수 :
4인용 특허 :
10
초록▼
A sealed flexible pouch having an aseptic interior, the sealed flexible pouch including a container for holding a pharmaceutical solution, one or more additional components, and a template frame, wherein the container and the one or more additional components are affixed to a template frame in a pre
A sealed flexible pouch having an aseptic interior, the sealed flexible pouch including a container for holding a pharmaceutical solution, one or more additional components, and a template frame, wherein the container and the one or more additional components are affixed to a template frame in a predetermined first arrangement and provided inside the sealed flexible pouch.
대표청구항▼
1. A sealed flexible pouch comprising the following provided inside the pouch: a container for holding a pharmaceutical solution;one or more additional components for filling the container with the pharmaceutical solution; anda template frame affixing the container and the one or more additional com
1. A sealed flexible pouch comprising the following provided inside the pouch: a container for holding a pharmaceutical solution;one or more additional components for filling the container with the pharmaceutical solution; anda template frame affixing the container and the one or more additional components in a predetermined first arrangement, wherein the container and the one or more additional components are held out of direct physical contact from one another to be assembled into a second arrangement without opening the sealed flexible pouch. 2. The sealed flexible pouch of claim 1, wherein the sealed flexible pouch is sterilized so that the sealed flexible pouch has an aseptic internal space and the container, the one or more additional components, and the template frame are sterilized. 3. The sealed flexible pouch of claim 1, wherein the one or more additional components comprise a vented spike for puncturing a septum and relieving pressure in the container when filling the container. 4. The sealed flexible pouch of claim 1, wherein the one or more additional components comprise a valve that provides a sterility barrier when removed from the flexible pouch. 5. The sealed flexible pouch of claim 1, wherein the one or more additional components comprise a membrane filter for sterilizing the pharmaceutical solution when filling the container. 6. A sealed flexible pouch comprising the following provided inside the sealed flexible pouch: a container pre-filled with a pharmaceutical solution;one or more additional components for withdrawing the pharmaceutical solution from the container; anda template frame affixing the container and the one or more additional components in a predetermined first arrangement, wherein the container and the one or more additional components are held out of direct physical contact from one another to be assembled into a second arrangement without opening the sealed flexible pouch. 7. The sealed flexible pouch of claim 6, wherein the sealed flexible pouch is sterilized so that the sealed flexible pouch has an aseptic internal space and the container, the one or more additional components, and the template frame are sterilized. 8. The sealed flexible pouch of claim 6, wherein the one or more additional components comprise a needle or a syringe. 9. A method for preparing a sealed flexible pouch having an aseptic interior comprising the following provided inside the sealed flexible pouch: a container for holding a pharmaceutical solution; one or more additional components for subsequent processing of the container; and a template frame holding the container and the one or more additional components in a predetermined first arrangement, wherein the container and the one or more additional components are held out of direct physical contact from one another the method comprising: (a) providing a flexible pouch having a sealable opening;(b) affixing the container and the one or more additional components to the template frame in the predetermined first arrangement;(c) placing the template frame inside the flexible pouch;(d) sealing the sealable opening of the flexible pouch; and(e) sterilizing the sealed flexible pouch. 10. The method of claim 9, further comprising a step of pre-filling the container with a pharmaceutical solution before step (b). 11. The method of claim 9, further comprising a step of placing ancillary components and/or reagents inside the flexible pouch after step (c) but before step (d). 12. The method of claim 9, wherein at least the steps (b), (c), and (d) are carried out in a cleanroom environment. 13. The method of claim 9, wherein the cleanroom environment is at least ISO class 8 environment. 14. The method of claim 9, wherein the sterilizing is carried out by EtO sterilization, gamma irradiation, or steam sterilization. 15. A method for assembling a container for holding a pharmaceutical solution and one or more additional components, wherein the container and the one or more additional components are affixed to a template frame in a predetermined first arrangement, wherein the container and the one or more additional components are held out of direct physical contact from one another and provided inside a sealed flexible pouch having an aseptic interior, when filling the container with the pharmaceutical solution, the method comprising: assembling the container and the one or more components into a second arrangement without opening the sealed flexible pouch while the container and the one or more additional components remain inside the sealed flexible pouch. 16. The method of claim 15, wherein the one or more additional components comprises a vented spike and the assembling step includes puncturing a septum on the container by inserting the vented spike through the septum. 17. The method of claim 15, wherein the additional components include a syringe with a needle that is used to withdraw the sterile solution from the container after opening the pouch.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (10)
Reboul, Gerard, Device and procedure for the extemporaneous preparation of an individual quantity of sterile liquid.
Page Roger E. (Hayling Island GBX) Morris Keith S. (Emsworth GBX) Lowe Graham D. (Hayling Island GBX) Matkovich Vlado I. (Glen Cove NY), Process and apparatus for removal of unwanted fluids from processed blood products.
Husnu, Mehmet; Eshima, Dennis; Alcaide, Derrick Michael; Danhof, Scott Nicholas; Gleeson, James B.; Hassenpflug, Eric Gustin; Prescott, James Alan, Closed vial fill system for aseptic dispensing.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.