Wireless temperature sensing system for lyophilization processes

• US 20060239331A1
• Filed: 04/26/2005
• Published: 10/26/2006
• Est. Priority Date: 04/26/2005
• Status: Active Grant

• Current Assignee: John Jeffrey Schwegman
• Original Assignee: John Jeffrey Schwegman
• Inventors: Schwegman, John Jeffrey
• Granted Patent: US 7,520,670 B2
• Time in Patent Office: Days
• US Class Current: 374/179
• CPC Class Codes: F26B 5/06 the process involving freezing
• CPC Class Codes: G01K 1/024 for remote indication

Abstract

A wireless parameter sensing system for a flask for use in lyophilization as well as a method of controlling a lyophilization process based on the sensed readings is disclosed. The wireless parameter sensing system may include a stopper adapted to be removably secured to an open end of the flask. A control unit may be positioned within an inner portion of the stopper. A parameter sensor may be connected with the control unit. A radio frequency transmitter may be connected with the control unit, wherein the control unit is operable to periodically transmit a parameter reading from the parameter sensor with the radio frequency transmitter.

Claims

1. A stopper for a flask including a wireless parameter sensing system, comprising:

a stopper adapted to be removably secured to an open end of said flask;

a control unit;

a parameter sensor connected with said control unit; and

a radio frequency transmitter connected with said control unit, wherein said control unit is operable to periodically transmit a parameter reading from said parameter sensor with said radio frequency transmitter.

2. The stopper of claim 1, wherein said parameter sensor comprises a thermocouple, wherein said thermocouple extends downwardly from a lower surface of said stopper a predetermined distance inside said flask.

3. The stopper of claim 1, further comprising an analog-to-digital converter connected with said parameter sensor and said control unit, wherein said analog-to-digital converter converts an analog parameter signal from said parameter sensor to a digital signal for use by said control unit.

4. The stopper of claim of claim 1, wherein said stopper is made from a resilient insulating material.

5. The stopper of claim 1, wherein a portion of said radio frequency transmitter is exposed on an upper surface of said stopper.

6. The stopper of claim 1, further comprising a receiver for receiving said parameter reading.

7. The stopper of claim 1, further comprising means in said stopper for ventilating water vapor from said flask.

8. The stopper of claim 1, wherein said control unit and at least a portion of said radio frequency transmitter is located inside said stopper.

9. The stopper of claim 1, wherein said control unit and at least a portion of said radio frequency transmitter is positioned within a housing connected to an upper surface of said stopper.

10. The stopper of claim 1, further comprising a power source removably connected with said control unit, wherein said power source is located within said stopper.

11. The stopper of claim 1, further comprising a pre-sterilized particle free package storing said stopper.

12. A wireless temperature system for a lyophilization machine, comprising:

a stopper adapted to be removably secured to an open end of a flask;

a controller positioned within an inside portion of said stopper;

a temperature sensor connected with said controller operable to take a plurality of product temperature readings of a substance contained in said flask over a predetermined period of time;

a radio frequency transmitter connected with said controller;

a receiver located within radio transmission range of said radio frequency transmitter; and

a lyophilization machine control unit connected with said receiver.

13. The wireless temperature system of claim 12, wherein said temperature sensor is a thermocouple.

14. The wireless temperature system of claim 12, wherein said thermocouple protrudes downwardly into said substance a predetermined distance from a lower surface of said stopper.

15. The wireless temperature system of claim 12, wherein said temperature sensor is an infrared laser.

16. The wireless temperature system of claim 12, wherein at least a portion of said radio frequency transmitter is positioned within said stopper.

17. The wireless temperature system of claim 12, wherein at least a portion of said radio frequency transmitter is exposed on an upper surface of said stopper.

18. The wireless temperature system of claim 12, further comprising a power source removably connected with said controller.

19. The wireless temperature system of claim 12, wherein said lyophilization machine control unit is operable to adjust a shelf temperature and/or a vacuum level setting of said lyophilization machine as a function of said product temperature reading.

20. The wireless temperature system of claim 12, further comprising an analog-to-digital converter connected with said radio frequency transmitter and said controller.

21. The wireless temperature system of claim 20, wherein said analog-to-digital converter converts an analog voltage signal generated by said temperature sensor to a digital temperature signal.

22. A method of monitoring temperature in a lyophilization machine, comprising the steps of:

capping a vial with a stopper including a temperature sensor connected with a control unit;

taking a product temperature reading of a substance within said vial; and

wirelessly transmitting said temperature reading to a radio frequency receiver with a radio frequency transmitter that is connected with said control unit.

23. The method of claim 22, wherein at least a portion of said radio frequency transmitter is positioned within said stopper.

24. The method of claim 22, wherein at least a portion of said radio frequency transmitter is exposed on an upper surface of said stopper.

25. The method of claim 22, further comprising the step of recording said product temperature reading in a database.

26. The method of claim 22, further comprising the step of adjusting a shelf temperature and/or a vacuum level setting of said lyophilization machine as a function of said product temperature reading.

27. The method of claim 22, further comprising the step of allowing water vapor to exit said vial through a means for ventilating said vial.

28. A temperature monitoring system for a vial, comprising:

a body in the form of a resilient stopper that may be removably secured to an open end of said vial;

means for monitoring a temperature value of a substance contained in said vial; and

means positioned in at least a portion of said stopper for wirelessly transmitting said temperature value to a radio receiver.

29. The temperature monitoring system of claim 28, further comprising a lyophilization machine control unit connected with said radio receiver.

30. The temperature monitoring system of claim 29, further comprising a temperature database for storing a plurality of temperature values.

31. The temperature monitoring system of claim 28, further comprising computer programmable code for adjusting a shelf temperature and/or a vacuum level setting of a lyophilization machine as a function of said product temperature value.