PROCESS CONTROL USING NON-INVASIVE PRINTED PRODUCT SENSORS

• US 20180274986A1
• Filed: 01/27/2016
• Published: 09/27/2018
• Est. Priority Date: 01/28/2015
• Status: Active Grant

• Current Assignee: IMA LIFE North America Inc., Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Original Assignee: IMA LIFE North America Inc., Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: GANGULY, ARNAB, RENZI, ERNESTO, DEMARCO, FRANCIS W., RAGHUNATHAN, NITHIN, PEROULIS, DIMITRIOS
• Granted Patent: US 10,641,661 B2
• Time in Patent Office: Days
• CPC Class Codes: B65D 1/09 Ampoules specially adapted for medical or pharmaceutical purposes A61J1/06
• CPC Class Codes: F26B 5/06 the process involving freezing
• CPC Class Codes: G01K 1/024 for remote indication
• CPC Class Codes: G01K 1/026 arrangements for monitoring a plurality of temperatures, e.g. by multiplexing
• CPC Class Codes: G01K 2213/00 Temperature mapping
• CPC Class Codes: G01K 7/028 using microstructures, e.g. made of silicon

Abstract

An arrangement for monitoring a freeze drying process includes product condition sensors for product condition measurement within product vials. The product condition sensors are bimetal junctions deposited on a substrate using an ink jet printing process. The substrate may be a flexible film applied to an interior surface of the product vial, or may be the vial surface itself. The bimetal junction may be printed using a roll-roll inkjet printing process with metallic nanoparticle inks. Multiple closely-spaced bi-metal junctions are provided in each measurement vial. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The location of a sublimation front may be calculated for each measured vial, and the freeze drying process may be controlled using the data.

Claims

1. A container apparatus for processing a product, comprising:

a product containment vial having an interior surface defining a product containment space in communication with an exterior of the product containment vial via a vial opening; and

a plurality of product condition sensors located on the interior surface of the product containment vial incrementally spaced from the vial opening for measuring a condition profile of the product within the product containment space, the product condition sensors each comprising metallic particles in a dried ink suspension deposited as at least one strip on a substrate.

2. The apparatus of claim 1, wherein the product condition sensors are thermocouples each comprising two strips having metallic particles of different types, and the condition profile of the product is a temperature profile.

3. The apparatus of claim 1, wherein the substrate is a flexible film applied to the interior surface of the product containment vial.

4. The apparatus of the preceding claim, wherein the at least one strip is deposited on the flexible film using a roll-roll inkjet printing process.

5. The apparatus of claim 1, wherein the substrate is the interior surface of the product containment vial.

6. The apparatus of claim 1, further comprising:

a processor connected for receiving measurements from the product condition sensors and transmitting measurement data via a local wireless network; and

a radio frequency energy harvesting board connected for powering the processor using a received wireless powering signal.

7. The apparatus of the preceding claim, further comprising:

a closure positioned in the vial opening, the processor and the radio frequency energy harvesting board being supported by the closure.

8. The apparatus of the preceding claim, further comprising:

a disengageable electrical connector connecting the product condition sensors to the processor.

9. The apparatus of claim 6, wherein the local wireless network utilizes an ANT™

communications protocol.

10. The apparatus of claim 6, wherein the processor is configured to transmit a unique network ID of the container apparatus via the local wireless network.

11. The apparatus of claim 6, further comprising:

a communications antenna connected to the processor to transmit the measurement data via the local wireless network.

12. The apparatus of the preceding claim, wherein the processor, the radio frequency energy harvesting board and the communications antenna are mounted on a common printed circuit board.

13. The apparatus of claim 1, wherein adjacent ones of the plurality of product condition sensors are spaced apart less than 2 mm.

14. The apparatus of the preceding claim, wherein the plurality of sensors comprises more than two sensors.

15. The apparatus of claim 13, wherein the plurality of sensors comprises more than six sensors.

16. A method for preparing a container for measuring a temperature profile in a product contained in the container, comprising:

directing an ink jet onto a flexible substrate to print strips on the substrate to form a flexible substrate with deposited bimetal thermocouples, the ink jet comprising metallic particles in a liquid suspension;

after directing the ink jet onto the flexible substrate, applying the flexible substrate with deposited bimetal thermocouples to an interior surface of the container; and

electronically connecting the bimetal thermocouples to electronics for measuring the temperature profile.

17. The method of the preceding claim, wherein the strips form an array of at least six bimetal thermocouples.

18. The method of claim 16, wherein the flexible substrate is a polypropylene film.

19. A system for aseptic processing of a product, comprising:

a processing chamber including an arrangement for supporting a plurality of product vials;

a measurement product vial assembly comprising;

a measurement product vial for containing a portion of the product;

a plurality of product condition sensors at a plurality of locations spaced incrementally from an opening of the measurement product vial and attached to an inside surface of the measurement product vial for measuring a condition of the product in the measurement product vial, the product condition sensors comprising first and second metallic strips comprising metal-containing inks printed on a substrate;

a processor connected for receiving measurements by the product condition sensor and transmitting measurement data via a local wireless network; and

a radio frequency energy harvesting board connected for powering the processor using a received wireless powering signal;

a radio frequency power transmission system for powering the radio frequency energy harvesting board within the processing chamber via the wireless powering signal; and

a wireless communications transceiver configured for communications with the processor via the local wireless network.

20. The system of the preceding claim, wherein the product condition sensors are thermocouples.

21. The system of claim 19, wherein the first and second metallic strips comprise two metal-containing inks printed on a flexible film applied to the inside surface of the measurement product vial.

22. The system of claim 19, wherein the metal-containing inks are printed on the flexible film using a roll-roll inkjet printing process.

23. The system of claim 19, wherein the first and second metallic films comprise metallic films deposited on the inside surface of the measurement product vial.

24. The system of claim 19, further comprising:

environmental control apparatus connected for controlling environmental conditions within the processing chamber based on the measurement data.

25. The system of claim 19, further comprising a plurality of measurement product vial assemblies, wherein each measurement product vial assemblies of the plurality of measurement product vial assemblies utilizes a unique network ID in the communications with the wireless communications transceiver.

26. The system of claim 19, wherein the arrangement for supporting the plurality of product vials comprises a plurality of shelves, each individual shelf having an individual adjustable heat transfer system for transferring heat from the shelf to vials supported by the shelf, and wherein the individual adjustable heat transfer system of an individual shelf is regulated based on measurement data pertaining to a measurement product vial supported by the individual shelf.