IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0348877
(2012-10-04)
|
등록번호 |
US-9920989
(2018-03-20)
|
우선권정보 |
EP-11008057 (2011-10-05) |
국제출원번호 |
PCT/EP2012/004162
(2012-10-04)
|
국제공개번호 |
WO2013/050156
(2013-04-11)
|
발명자
/ 주소 |
- Luy, Bernhard
- Plitzko, Matthias
- Struschka, Manfred
|
출원인 / 주소 |
|
인용정보 |
피인용 횟수 :
0 인용 특허 :
4 |
초록
▼
A process line (300) for the production of freeze-dried particles under closed conditions comprising at least a spray chamber (302) for droplet generation and freeze congealing of the liquid droplets to form particles and a bulk freeze-dryer (304) for freeze drying the particles, the freeze-dryer (3
A process line (300) for the production of freeze-dried particles under closed conditions comprising at least a spray chamber (302) for droplet generation and freeze congealing of the liquid droplets to form particles and a bulk freeze-dryer (304) for freeze drying the particles, the freeze-dryer (304) comprising a rotary drum for receiving the particles. Further, a transfer section (308) is provided for a product transfer from the spray chamber (302) to the freeze-dryer (304). For the production of the particles under end-to-end closed conditions each of the devices (302, 304) and of the transfer section (308) is separately adapted for operation preserving sterility of the product to be freeze-dried and/or containment.
대표청구항
▼
1. A process line for the production of freeze-dried particles under closed conditions, the process line comprising at least the following process devices: a spray chamber for generation of discrete liquid droplets and freeze congealing of the liquid droplets to form particles; anda bulk freeze-drye
1. A process line for the production of freeze-dried particles under closed conditions, the process line comprising at least the following process devices: a spray chamber for generation of discrete liquid droplets and freeze congealing of the liquid droplets to form particles; anda bulk freeze-dryer for freeze drying the particles, the freeze-dryer comprising a rotary drum for receiving the particles; wherein a transfer section is provided for a particle transfer from the spray chamber to the freeze-dryer, wherein the transfer section permanently interconnects the process devices to form an integrated process line for the production of the particles under end-to-end closed conditions,for the production of the particles under end-to-end closed conditions each of the process devices and of the transfer section is separately adapted for operation preserving sterility of the particles to be freeze-dried and/or containment in order to provide a flexibly adaptable process line for enabling independent control of an operational mode of each process device, whereinthe process line is cleanable in place (“CiP”) and/or sterilizable in place (“SiP”), andthe spray chamber comprises a double wall defining an internal volume therein, which double wall houses sterilization piping providing sterilization medium supply for sterilization of the spray chamber. 2. The process line according to claim 1, at least one of the process devices and the transfer section comprises a confining wall which is adapted for providing predetermined process conditions within a confined process volume, wherein the confining wall is adapted for isolating the process volume and an environment of the process devices from each other. 3. The process line according to claim 1, wherein the process devices and the transfer section form an integrated process line providing end-to-end protection of sterility of the particles and/or end-to-end containment of the particles. 4. The process line according to claim 1, wherein the freeze-dryer is adapted for separated operation under closed conditions, the separated operation including at least one of particle freeze-drying, cleaning of the freeze-dryer, and sterilization of the freeze-dryer. 5. The process line according to claim 1, wherein the integrated process line comprises as further device a product handling device adapted for at least one of discharging the particles from the process line, taking particle samples, and manipulating the particles under closed conditions. 6. The process line according to claim 1, wherein the spray chamber comprises at least one temperature-controlled wall for freeze congealing the liquid droplets. 7. The process line according to claim 1, wherein the freeze-dryer is a vacuum freeze-dryer. 8. The process line according to claim 1, wherein the transfer section of the process line comprises at least one temperature-controlled wall. 9. The process line according to claim 8, wherein the at least one temperature-controlled wall is an actively cooled inner wall of the transfer section. 10. The process line according to claim 1, wherein the transfer section comprises means for operatively separating the process devices from each other such that at least one of the process devices is operable under closed conditions separately from the other process device without affecting the integrity of the process line, wherein the means for operatively separating the process devices from each other comprises a valve, a vacuum lock, and/or a component which enables sealably separating the components from each other. 11. The process line according to claim 10, wherein the valve is a vacuum-tight valve. 12. The process line according to claim 1, wherein the particles have a tendency to be generally spherical. 13. The process line of claim 1, wherein the function of cleanability in place (“CiP”) and/or sterilizability in place (“SiP”) is achieved automatically in place throughout the process line or in one or more of parts thereof. 14. The process line of claim 13, wherein the function of cleanability in place (“CiP”) and/or sterilizability in place (“SiP”) is achieved by a CiP/SiP system. 15. The process line of claim 14, wherein the CiP/SiP system comprises access points for introduction of a cleaning medium and/or a sterilization medium throughout the process line or in one or more of parts thereof. 16. The process line of claim 15, wherein the access points comprise nozzles or steam access points. 17. The process line of claim 16, wherein all or some of the access points are connected to a cleaning and/or sterilization medium repository/generator. 18. The process line of claim 1, wherein steam as a sterilization medium is supplied via the sterilization piping, which enters the spray chamber via one or more sterilization heads at access points on the inside wall of the vacuum chamber. 19. A process for the production of freeze-dried particles under dosed conditions performed by a process line according to claim 1, the process comprising at least the following process steps: generating liquid droplets and freeze congealing of the liquid droplets to form particles in a spray chamber;transferring the particles under closed conditions from the spray chamber to a freeze-dryer via a transfer section; andfreeze drying the particles as bulkware in the freeze-dryer, the freeze-dryer comprising a rotary drum for receiving the particles;wherein for the production of the particles under end-to-end closed conditions each of the process devices and of the transfer section is separately adapted for operation preserving sterility of the particles to be freeze-dried and/or containment in order to provide a flexibly adaptable process line for enabling independent control of an operational mode of each process device. 20. The process according to claim 19, wherein the particle transfer to the freeze-dryer is performed in parallel to droplet generation and freeze-congealing in the spray chamber. 21. The process according to claim 19, comprising a step of operatively separating spray chamber and freeze-dryer to perform Cleaning in Place (“CiP”) and/or Sterilization in Place (“SiP”) in one of the process devices. 22. A process for preparing a vaccine composition comprising one or more antigens in the form of freeze-dried particles comprising: freeze-drying a liquid bulk solution comprising said one or more antigens according to the process as described in claim 19; andfilling the freeze-dried particles obtained into a recipient. 23. A process according to claim 22, wherein all the steps of the process are carried out under sterile conditions. 24. A process according to claim 22, wherein the freeze-dried particles are sterile. 25. A process for preparing an adjuvant containing vaccine composition comprising one or more antigens in the form of freeze-dried particles comprising: a. freeze-drying a liquid bulk solution comprising said adjuvant and said one or more antigens according to the process as described in claim 19, andb. filling the freeze-dried particles obtained into a recipient; or alternatively when the liquid bulk solution of a) does not comprise said adjuvant,c. freeze-drying separately a liquid bulk of said adjuvant and a liquid bulk solution comprising said one or more antigens according to the process as described in claim 19,d. blending the freeze dried particles of said one or more tiger's with the freeze dried particles of adjuvant, ande. filling the blending of freeze-dried particles into a recipient. 26. A process according to claim 25, wherein all the steps of the process are carried out under sterile conditions. 27. A process according to claim 25, wherein the freeze-dried particles are sterile.
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