# US 10,441,506 B2 · Package for pharmaceutical product, comprising miniaturized electronic tag for monitoring product integrity

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- Number: US 10,441,506 B2
- Document ID: US10441506B2
- Status: Granted
- Kind: B2
- Application number: 14/890,508
- Filed: 2014-05-13
- Published: 2016-06-16
- Granted: 2019-10-15
- Earliest claimed: 2013-05-15
- Assignees: Q-Tag AG
- Applicants: Q-Tag AG
- Inventors: Corneliu Tobescu
- Web page: https://patentgrep.com/patent/US10441506B2

## CPC

- A61J 1/18: Arrangements for indicating condition of container contents, e.g. sterile condition
- G06K 19/0717: {the sensor being capable of sensing environmental conditions such as temperature history or pressure}
- G06K 19/07701: {the record carrier comprising an interface suitable for human interaction}
- G06K 19/07709: {the interface being a keyboard}
- G06K 19/07798: {part of the antenna or the integrated circuit being adapted for rupturing or breaking, e.g. record carriers functioning as sealing devices for detecting not-authenticated opening of containers (electronic seals G09F3/03)}
- A61J 1/035: {Blister-type containers (blisters in general B65D75/36)}
- A61J 2205/60: using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- G06K: GRAPHICAL DATA READING (image or video recognition or understanding G06V); PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS

## Abstract

A retail package for a perishable product includes a box as an outer package; and an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of the product to physical or environmental conditions during a time span. The tag has a main part including an electronics unit and a rip strip having a breakable electrical connection operationally connected to the electronics unit. The electronics unit includes a control unit; at least one sensor for monitoring the physical or environmental conditions; a display for displaying data relating to the integrity; and a switch. The control unit is structured and configured to detect a breaking of the electrical connection; to terminate the monitoring in reaction to detection of breaking of the electrical connection; and to effect that the display unit displays the status data in reaction to an operation of the switch.

## Claims

### Claim 1

A retail package for a perishable product, said retail package comprising:
a box as an outer package;
an electronic tag for obtaining information relating to integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span, wherein said physical or environmental conditions include at least one of temperature, humidity, pressure and acceleration;
said tag comprising:
a main part comprising an electronics unit;
a rip strip comprising a breakable electrical connection operationally connected to said electronics unit;
said electronics unit comprising:
a control unit;
a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions;
a display unit comprising a display for displaying data relating to said integrity referred to as status data;
a switch;
wherein said control unit is structured and configured to:
detect a breaking of said electrical connection;
terminate said monitoring in reaction to detection of said breaking of said electrical connection; and to
effect that said display unit displays said status data in reaction to an operation of said switch.

### Claim 2 (depends on 1)

The package according to claim 1, wherein said perishable product is a pharmaceutical product.

### Claim 3 (depends on 1)

The package according to claim 1, wherein said main part is attached to an inside of said box.

### Claim 4 (depends on 1)

The package according to claim 1, wherein said box is a folding carton.

### Claim 5 (depends on 1)

The package according to claim 1, wherein said rip strip is attached to an inside of said box.

### Claim 6 (depends on 5)

The package according to claim 5, wherein said box is designed to have one or more opening sides at which the box can be opened in order to access said product when the product is present inside the box, and wherein said rip strip is attached to said box in such a way that said electrical connection is broken when the box is opened at one of said opening sides.

### Claim 7 (depends on 1)

The package according to claim 1, wherein said rip strip comprises or essentially is a printed circuit board in and/or on which at least one conductor line is present that is operationally connected to said electronics unit, said at least one conductor line forming said breakable electrical connection.

### Claim 8 (depends on 1)

The package according to claim 1, wherein said display unit comprises one or more light emitters for emitting light pulses, and wherein said data is encoded in a sequence of light pulses emitted by said one or more light emitters, said data is encoded in one or more of:
the color of the light pulses;
a duration of the light pulses;
the number of the light pulses in the sequence.

### Claim 9 (depends on 1)

A retail unit comprising a retail package according to claim 1, further comprising said perishable product.

### Claim 10 (depends on 9)

The retail unit according to claim 9, wherein said retail unit is a pharmaceutical retail unit, and said perishable product is a pharmaceutical product.

### Claim 11 (depends on 9)

The retail unit according to claim 9, wherein said retail unit comprises one or more containers containing said product.

### Claim 12

A method for monitoring an integrity of a perishable product, the method comprising the steps of:
providing an electronic tag; and
providing a box as an outer package for said perishable product;
wherein said tag is a tag for obtaining information relating to the integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span, wherein said physical or environmental conditions include at least one of temperature, humidity, pressure and acceleration, the tag comprising:
a main part comprising an electronics unit;
a rip strip comprising a breakable electrical connection operationally connected to said electronics unit;
said electronics unit comprising:
a control unit;
a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions;
a display unit comprising a display for displaying data relating to said integrity referred to as status data;
a switch;
wherein said control unit is structured and configured to perform the steps of:
detecting a breaking of said electrical connection;
terminating said monitoring in reaction to said detecting said breaking of said electrical connection; and
effecting that said display unit displays said status data in reaction to an operation of said switch.

### Claim 13 (depends on 12)

The method according to claim 12, comprising at least one of the steps of
bonding said main part to said box;
bonding at least a portion of said rip strip to said box.

### Claim 14 (depends on 12)

The method according to claim 12, comprising at least one of the steps of:
ripping said rip strip;
operating said switch.

### Claim 15

A method for manufacturing a retail unit comprising a perishable product, said method comprising the steps of:
a) providing said product;
b) providing an unfolded folding carton;
c) folding said folding carton;
d) inserting said product into the folded folding carton;
e) providing an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span, wherein said physical or environmental conditions include at least one of temperature, humidity, pressure and acceleration, said tag comprising a main portion and a rip strip;
f) attaching said tag to said folding carton;
wherein said tag comprises:
said main part comprising an electronics unit;
said rip strip comprising a breakable electrical connection operationally connected to said electronics unit;
said electronics unit comprising:
a control unit;
a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions;
a display unit comprising a display for displaying data relating to said integrity referred to as status data;
a switch;
wherein said control unit is structured and configured to perform the steps of:
detecting a breaking of said electrical connection;
terminating said monitoring in reaction to said detecting said breaking of said electrical connection; and for
effecting that said display unit displays said status data in reaction to an operation of said switch;
the method further comprising the step of:
g) starting monitoring said exposure of said product to said physical or environmental conditions by manipulating a part of said tag.

### Claim 16

An electronic tag for obtaining information relating to the integrity of a product as assessed from an exposure of said product to physical or environmental conditions during a time span, wherein said physical or environmental conditions include at least one of temperature, humidity, pressure and acceleration, said tag comprising:
a main part comprising an electronics unit;
a rip strip comprising a breakable electrical connection operationally connected to said electronics unit;
said electronics unit comprising:
a control unit;
a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions;
a display unit comprising a display for displaying data relating to said integrity referred to as status data;
a switch;
wherein said control unit is structured and configured to:
detect a breaking of said electrical connection;
terminate said monitoring in reaction to said detection of breaking of said electrical connection; and
effect that said display unit displays said status data in reaction to an operation of said switch.

### Claim 17 (depends on 12)

The method according to claim 12, further comprising the steps of:
calculating and storing final status data in response to breaking of said electrical connection.

### Claim 18 (depends on 17)

The method according to claim 17, comprising the further step of:
displaying said final status data on said display device for a predetermined period of time when monitoring is terminated.

### Claim 19 (depends on 1)

The package according to claim 1, wherein data representative of prescribed limitations of sensed physical or environmental conditions is stored in said electronics unit, and said physical or environmental conditions sensed by the sensor are compared to the stored prescribed limitations to determine the integrity of the product.

### Claim 20 (depends on 19)

The package according to claim 19, wherein the product is determined to have integrity if the sensed physical or environmental conditions are within a range of the prescribed limitations and the product is determined to have lost integrity if the sensed physical or environmental conditions are outside the range of the prescribed limitations.

### Claim 21 (depends on 1)

The package according to claim 1, wherein the display unit displays status data indicating that the integrity of the product is not acceptable if the product has been subjected to physical or environmental conditions that are outside a range of the prescribed limitations.

### Claim 22 (depends on 1)

The package according to claim 1, wherein the physical or environmental conditions are monitored by said sensor to determine whether a threshold value, indicative that the product has lost integrity, has been reached.

### Claim 23 (depends on 12)

The method according to claim 12, comprising the further steps of:
storing data representative of prescribed limitations of sensed physical or environmental conditions in said electronics unit, and
comparing said physical or environmental conditions sensed by the sensor to the stored prescribed limitations to determine the integrity of the product.

### Claim 24 (depends on 12)

The method according to claim 12, comprising the further step of:
upon operation of said switch, displaying status data indicating that the product is not acceptable when the product has been subjected to physical or environmental conditions outside a range of prescribed limitations.

### Claim 25 (depends on 12)

The method according to claim 12, wherein the sensor measures physical or environmental conditions at predetermined time intervals.

### Claim 26 (depends on 15)

The method according to claim 15, wherein data representative of prescribed limitations of sensed physical or environmental conditions is stored in said electronics unit, and said physical or environmental conditions sensed by the sensor are compared to the stored prescribed limitations to determine the integrity of the product.

### Claim 27 (depends on 26)

The method according to claim 26, wherein the product is determined to have integrity if the sensed physical or environmental conditions are within a range of prescribed limitations and the product is determined to have lost integrity if the sensed physical or environmental conditions are outside the range of prescribed limitations.

### Claim 28 (depends on 16)

The electronic tag according to claim 16, wherein data representative of prescribed limitations of sensed physical or environmental conditions is stored in said electronics unit, and said physical or environmental conditions sensed by the sensor are compared to the stored prescribed limitations to determine the integrity of the product.

### Claim 29 (depends on 28)

The electronic tag according to claim 28, wherein the product is determined to have integrity if the sensed physical or environmental conditions are within a range of prescribed limitations and the product is determined to have lost integrity if the sensed physical or environmental conditions are outside the range of prescribed limitations.
