IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0348869
(2012-10-04)
|
등록번호 |
US-10006706
(2018-06-26)
|
우선권정보 |
EP-11008057 (2011-10-05) |
국제출원번호 |
PCT/EP2012/004168
(2012-10-04)
|
국제공개번호 |
WO2013/050162
(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 is provided, the process line comprising at least the following separate devices: a spray chamber (302) for droplet generation and freeze congealing of the liquid droplets to form particles, and a bulk freeze-d
A process line (300) for the production of freeze-dried particles under closed conditions is provided, the process line comprising at least the following separate devices: 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, wherein 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 closed operation, and the spray chamber (302) is adapted for separation of the liquid droplets from any cooling circuit.
대표청구항
▼
1. A process line for the production of freeze-dried particles under closed conditions, the process line comprising at least the following separate process devices: a spray chamber for generation of discrete liquid droplets and freeze congealing of the liquid droplets to form particles; anda bulk fr
1. A process line for the production of freeze-dried particles under closed conditions, the process line comprising at least the following separate 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; whereina transfer section is provided for a product transfer from the spray chamber to the freeze-dryer;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 closed operation,the spray chamber comprises a double wall with an outer wall and a cooled inner wall encompassing an inner volume, said double wall defining an internal volume and said inner wall being cooled by a cooling circuitry comprising a tube system extending throughout at least a part of said internal volume of said double wall, said inner volume providing a non-circulating medium, said cooled inner wall and said non-circulating medium being the only cooling component for freezing the droplets, for avoiding a counter- or concurrent cooling flow. 2. 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 product and/or end-to-end containment of the product. 3. The process line according to claim 1, wherein the transfer section comprises means for operatively separating the process devices from each other such that the 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. 4. The process line according to claim 3, wherein the means for operatively separating the process devices from each other is a vacuum-tight valve. 5. The process line according to claim 1, wherein 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. 6. 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 product and/or end-to-end containment of the product. 7. 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. 8. The process line according to claim 1, wherein the process line comprises as a further process device a product handling device adapted for at least one of discharging the product from the process line, taking product samples, and manipulating the product under closed conditions. 9. The process line according to claim 1, wherein the spray chamber comprises at least one temperature-controlled wall for freeze congealing the liquid droplets. 10. The process line according to claim 1, wherein the freeze-dryer is a vacuum freeze-dryer. 11. The process line according to claim 1, wherein the freeze-dryer comprises a rotary drum for receiving the particles. 12. The process line according to claim 11, wherein the particles have a tendency to be generally spherical. 13. The process line according to claim 1, wherein the transfer section of the process line comprises at least one temperature-controlled wall. 14. The process line according to claim 1, wherein the entire process line is adapted for Cleaning in Place “CiP” and/or Sterilization in Place “SiP”. 15. The process line according to claim 14, wherein the at least one temperature-controlled wall is an actively cooled inner wall of the transfer section. 16. The process line according to claim 1, wherein the liquid droplets freeze during their fall in the spray chamber in order to form frozen particles. 17. A process for the production of freeze-dried particles under closed 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 form particles in a spray chamber;transferring the product 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,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 closed operation. 18. The process according to claim 17, wherein the product transfer to the freeze-dryer is performed in parallel to droplet generation and freeze-congealing in the spray chamber. 19. The process according to claim 17, 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. 20. 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 17, andfilling the freeze-dried particles obtained into a recipient. 21. A process according to claim 20, wherein all the steps of the process line are carried out under sterile conditions. 22. 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 17, 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 17,d. blending the freeze dried particles of said one or more antigens with the freeze dried particles of adjuvant, ande. filling the blending of freeze-dried particles into a recipient. 23. A process according to claim 22, wherein the freeze-dried particles are sterile. 24. The process according to claim 17, wherein the liquid droplets freeze during their fall in the spray chamber in order to form frozen particles.
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