Large-scale lyophilization device

• US 8,677,649 B2
• Filed: 06/16/2009
• Issued: 03/25/2014
• Est. Priority Date: 06/19/2008
• Status: Active Grant

• Current Assignee: Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg
• Original Assignee: Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg
• Inventors: Bttger, Frank, Huptle, Martin
• Primary Examiner(s): Gravini, Steve M
• Application Number:
  US12/999,021
• Publication Number:
  US 20110099836A1
• Time in Patent Office: 1,743 Days
• Field of Search: 34/84, 34/27, 343/81, 344/13, 344/97, 34/92, 435/4, 435/13, 435/287.2, 356/427, 356/428, 356/335, 424/1.65, 424/1.17, 424/1.21
• US Class Current: 34/284
• CPC Class Codes: F26B 5/06 the process involving freezing
• CPC Class Codes: G03B 15/00 Special procedures for taking photographs; Apparatus therefor

Abstract

A device for large-scale lyophilization of pharmaceutical solutions in medical hollow bodies, includes a lyophilization device and at least one camera. Images of at least one pharmaceutical solution to be lyophilized are recorded by the at least one camera. The images may be used for controlling and/or monitoring the lyophilization process.

Claims

1. A device for large-scale lyophilization of pharmaceutical solutions in medical hollow bodies, the device comprising:

a lyophilization unit; and

at least one camera for recording images of at least one pharmaceutical solution to be lyophilized, the images adapted to be used for controlling and/or monitoring a lyophilization process, the at least one camera arranged within an interior of the lyophilization unit.

2. The device according to claim 1, further comprising an evaluation unit for evaluating the images.

3. The device according to claim 2, wherein the evaluation unit is operative to change parameters of the lyophilization process.

4. The device according to claim 3, wherein signals are transmitted from the evaluation unit to a control device of the lyophilization unit, and based on the evaluation of the images, the parameters of the lyophilization process are changed in response to the signals.

5. The device according to claim 1, wherein the at least one camera is an analog camera, a digital camera, a macro camera, or a webcam.

6. The device according to claim 1, further comprising a lighting unit.

7. The device according to claim 6, wherein the at least one camera includes the lighting unit.

8. The device according to claim 7, wherein the lighting unit is integrated into the at least one camera.

9. The device according to claim 1, further comprising at least one vacuum-tight housing accommodating the at least one camera and enclosing the at least one camera in a vacuum-tight manner.

10. The device according to claim 1, wherein the at least one camera is operable in a temperature range of −

60°

C. to 60°

C.

11. The device according to claim 9, wherein the at least one camera and/or the at least one vacuum-tight housing have a low particle density.

12. The device according to claim 9, wherein the at least one camera and/or the at least one vacuum-tight housing are thermally insulated.

13. The device according to claim 9, wherein the at least one camera and/or the at least one vacuum-tight housing are sterilizable.

14. The device according to claim 9, further comprising a cartridge, the at least one camera and/or the at least one vacuum-tight housing may be fastened to the cartridge for holding the medical hollow bodies.

15. The device according to claim 1, wherein the at least one camera includes multiple cameras operable to record images of the at least one pharmaceutical solution from various directions.

16. The device according to claim 1, wherein the at least one camera is designed as an endoscopic system.

17. The device according to claim 1, wherein the at least one camera is sensitive in an invisible range of the electromagnetic spectrum.

22. The device according to claim 3, wherein the evaluation unit cooperates with a control device to automatically change parameters of the lyophilization process selected from a group consisting of temperature, pressure and humidity based on information obtained from the images.

23. The device according to claim 22, further comprising an image evaluation program for automatically evaluating the images with regard to a desired product quality.

18. A method for monitoring and/or controlling large-scale lyophilization of pharmaceutical solutions in medical hollow bodies, the method comprising:

providing a lyophilization unit and at least one camera;

arranging a camera within an interior of the lyophilization unit;

recording images of at least one pharmaceutical solution to be lyophilized from within the interior of the lyophilization unit with the at least one camera; and

controlling and/or monitoring a lyophilization process with images from the at least one camera.

19. The method according to claim 18, further comprising evaluating the images using an evaluation unit.

20. The method according to claim 19, further comprising changing parameters of the lyophilization process using the evaluation unit.

21. The method according to claim 20, wherein based on the evaluation of the images, signals are transmitted from the evaluation unit to a control device of the lyophilization unit, on a basis of which the parameters of the lyophilization process are changed.

24. The method according to claim 21, further comprising automatically changing parameters of the lyophilization process selected from a group consisting of temperature, pressure and humidity based on evaluation of the images.

25. The method according to claim 24, further comprising automatically evaluating the images with regard to a desired product quality with an image evaluation program.

26. A device for large-scale lyophilization of pharmaceutical solutions in medical hollow bodies, the device comprising:

a lyophilization unit;

at least one camera for recording images of at least one pharmaceutical solution to be lyophilized, the images adapted to be used for controlling and/or monitoring a lyophilization process;

an evaluation unit for evaluating the images, the evaluation unit operative to change parameters of the lyophilization process, by transmitting signals to a control device of the lyophilization unit such that parameters of the lyophilization process are changed in response to the signals based on evaluation of the images.

27. The device according to claim 26, wherein the evaluation unit cooperates with the control device to automatically change parameters of the lyophilization process selected from a group consisting of temperature, pressure and humidity based on information obtained from the images.