Description:FORM-2

THE PATENTS ACT, 1970
(39 OF 1970)
&
The Patent Rules, 2003

COMPLETE SPECIFICATION
(See Section 10 and Rule 13)

Title:
FLEXIBLE LABEL POUCH WITH INTEGRATED TEMPERATURE AND
TIME INDICATOR FOR PRODUCT MONITORING

Applicant Name Nationality Address
Exquinz Life Sciences Pvt Ltd
INDIAN KIIT TBI, KIIT University, Campu-11, Bhubaneswar
Odisha-751024, India

THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.
FIELD OF INVENTION
The present invention relates to the field of product monitoring during storage and transportation, specifically in the design of flexible label pouches used as temperature and time indicators. These labels are particularly suited for temperature-sensitive products, providing real-time tracking and alerts, making them valuable in industries such as healthcare, pharmaceuticals, and perishable goods.

BACKGROUND OF THE INVENTION
The need for effective monitoring of temperature-sensitive products such as food, vaccines, pharmaceuticals, chemicals, and perishable goods has become increasingly critical. These products often have short shelf lives and strict temperature requirements that, if breached, can lead to loss of efficacy, spoilage, or safety concerns. To address this, Time-Temperature Indicators (TTIs) have been developed to track the thermal history of these products and provide a visual indication of whether the product has been exposed to unfavorable conditions. TTIs play a crucial role in ensuring quality and safety during the entire supply chain—from manufacturing and storage to transportation and end-use.
Various TTIs have been introduced to the market, each employing different mechanisms to monitor temperature changes. Below are some prominent examples of existing products and their limitations:
- Fresh-Check® Time-Temperature Indicator: One of the more popular TTIs, Fresh-Check® uses thermochromic inks that undergo a visible color change based on the principle of solid-state polymerization of substituted monomers. The color change is triggered by temperature exposure, providing a visual cue that the product has exceeded its safe temperature limit. While this technology offers an innovative approach, it comes with significant drawbacks. First, the high cost of production limits its widespread use. Second, the indicator is highly sensitive to light exposure, which can cause inaccuracies. To protect the thermochromic inks, a radiation shielding plastic sheet is required, which increases production complexity and cost. Additionally, no fully efficient shielding sheet that can block all harmful wavelengths has been developed, leaving the indicator vulnerable to environmental interference.

- Vitsab Enzymatic Time-Temperature Indicator: This TTI is based on the time-temperature dependence of enzymatic reactions. The indicator consists of two compartments—one containing a water solution of lipolytic enzymes and another with a lipid substrate and pH indicator. When activated, the two solutions mix, triggering an enzymatic reaction that produces a visible color change based on temperature exposure over time. While innovative, the main issue with the Vitsab indicator is its activation process. Reagents must be stored separately until activation, requiring careful handling and storage at low temperatures, often under refrigeration. Additionally, some variations require the user to apply pressure to rupture a barrier between the solutions, which can be prone to user error or premature activation. This complexity limits its use in broader markets where ease of application is essential.
- 3M MonitorMark® Time-Temperature Indicator: This diffusion-based indicator uses a temperature-controlled, permeable membrane through which a chemical system diffuses. As temperature fluctuates, the movement of a blue dye through the track indicates the level of exposure to high temperatures. When all five windows of the indicator turn blue, it signals that the product has surpassed its safe temperature threshold. While the 3M MonitorMark® is highly effective, the cost per unit can be prohibitive, exceeding $2 per device. This high price makes it impractical for use in large-scale monitoring of low-margin products. Moreover, the indicator is relatively large and may not be suitable for all packaging or product surfaces.
- OnVu™ TTI (Ciba Specialty Chemicals & Fresh Point): The OnVu™ indicator is a newly introduced TTI based on solid-state reactions. It changes color in response to accumulated temperature exposure, providing a clear visual cue. However, the price of production is relatively high, and it suffers from similar issues of premature activation, especially in conditions where pressure or external force is needed to activate the reaction.
- Timestrips® Time-Temperature Indicator: Developed by Timestrip UK Limited, this indicator uses a pressure-activated gel that migrates along a visible track based on temperature exposure. Timestrips® have found limited use due to their relatively high cost and sensitivity to environmental conditions such as humidity and pressure, which can impact their reliability.

- Bauer & Knorr Pressure-Induced Starch Gelation Indicator: This unique Pressure Time-Temperature Indicator (PTTI) is based on starch gelation under pressure, making it particularly useful for high-pressure applications. However, its applicability to everyday consumer products is limited due to the complexity of its activation process and the specific conditions required for accurate monitoring.
- Vaccine Vial Monitors (TempTime Corporation): Vaccine vial monitors have gained widespread adoption in the healthcare industry, particularly in vaccine management. US Patent 10,514,340B2, granted to TempTime Corporation, discloses a heat indicator designed to change color in response to cumulative heat exposure. While this is a significant innovation in vaccine storage, the optical color change is often difficult to interpret, leading to potential errors in assessing the reference color for determining vaccine safety. This lack of precision can be problematic in critical healthcare settings. In addition, the VVM requires long term precondition steps such as store it at – Degrees for more than 24 hours prior use, which limits the use of the VVMs on emergency basis.
Several patents have also been filed related to temperature indicators. For instance, U.S. Pat. No. 5,368,905 involves a heat-fusible substance that activates upon rupture, yet its lack of pliability and large size make it unsuitable for flexible applications. Another prior art, U.S. Pat. No. 4,038,873, involves a frangible packet that releases a dye when ruptured, but this design is complicated and may not offer real-time precision. Other patents such as U.S. Pat. Nos. 5,120,137 and 3,954,011 focus on fluid migration through wicking materials, but these devices lack flexibility and are vulnerable to environmental factors like humidity.
Despite these advancements, existing TTIs have significant shortcomings such as high production costs, complex activation methods, bulky designs, pre-conditioning and susceptibility to environmental damage. Many require intricate assembly processes or expensive materials, making them less practical for wide-scale, economical applications.
The present invention addresses these challenges by introducing a label pouch and its use for integrating "Temp-Time Indicator" that offers several advantages. One of the key benefits is its construction from a single, flexible sheet, which makes the label pouch and subsequent indicator lightweight, durable, and cost-effective. The assembly process involves simple folding and sealing, reducing labor intensity and ensuring ease of use. The invention is designed to be economical and applicable across a wide range of products without compromising on functionality or precision, and eliminates the need for complex activation steps, making it a versatile and economical solution across industries like healthcare, food, pharmaceuticals, and chemicals.

OBJECT OF THE INVENTION
The primary objective of the present invention is to provide a flexible label pouch that could be used for various application including as a temp-time indicator. It serves as a temperature and time indicator for various temperature-sensitive products, ensuring real-time monitoring and timely alerts.
Another objective of the invention is to integrate a wicking sheet and an absorption sheet within the label, where the absorption sheet holds temperature-sensitive dye and controls the rate of diffusion based on product temperature, enhancing accuracy in monitoring.
Yet another objective is to offer a simple activation method by unfolding the label pouch, which ensures consistent and error-free activation, reducing human errors during use.
A further objective is to establish a straightforward process for the preparation of the label pouch, involving specific folds and sealing steps, resulting in a flexible, easy-to-manufacture pouch that can be applied to various surfaces with adhesive.
Yet another objective of the present invention is to provide a cost-effective, easy-to-apply label pouch that can be used across a wide range of products, improving their value without significantly increasing production costs.

SUMMARY OF THE INVENTION
The present invention relates to a flexible label pouch that offers use as a temperature and time indicator for various products. The label pouch is composed of a transparent to semi-transparent flexible sheet, marked on both sides to guide the folding process. The markings define specific fold dimensions and boundaries for easy assembly.
The present invention also provides method for preparing the novel pouch, the sheet is first folded in a forward direction at 1/4th of its length, followed by a backward fold at the halfway point. Once folded, the edges are sealed to form a secure pouch. The label can be activated by unfolding the second fold, after which it is applied to the desired surface using a double-sided adhesive.
Technically, the invention integrates critical components directly onto the flexible sheet. It includes an absorption sheet and a wicking sheet, where the latter acts as a reservoir for temperature-sensitive dye. Upon a temperature breach, the dye undergoes a solid-to-liquid transition and diffuses through the absorption sheet at a rate controlled by the temperature of the attached product. This temperature-dependent diffusion mechanism ensures real-time monitoring of the product’s condition, making it ideal for temperature-sensitive applications, such as vaccine storage and transport.
In some aspects of the present invention the said label pouch also features a simple activation method that minimizes human error. Activation occurs by unfolding the pre-folded section of the label, which initiates the temperature and time indicator. This method provides reliable and consistent activation, eliminating potential errors during manual handling. Furthermore, the low-cost production of the flexible label pouch makes it a versatile solution for a broad range of products, enhancing their market value while maintaining affordability.
In some related aspects the label pouch additionally includes a display window that provides users with clear visual indicators of both temperature breaches and remaining product usability time. This feature is particularly important for healthcare products, such as vaccines, where timely information is crucial to maintaining product efficacy. The combination of low-cost, ease of application, and reliable real-time monitoring makes this invention an ideal choice for industries requiring efficient temperature tracking and alert systems.

BRIEF DESCRIPTION OF DRAWINGS
The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes references to the annexed drawings wherein:
Figure. 1: Depicts the structure of flexible sheet (10) with lower and upper parts of the sheet and its markings for folding and ease of preparation with accuracy.
Figure. 2: Shows a flow chart of label pouch (11) making process.
Figure. 3: Shows a flow chart of “label pouch and integrated temperature time indicator” (22) preparation.
Figure. 4: Shows a flow chart of and alternate method for “label pouch and integrated temperature time indicator” (22) preparation.
Figure. 5: Shows set of steps involved in activating the label pouch with temp-time indicator.
Figure. 6: Shows instructions to interpret the response of the label pouch with temp-time indicator.
Figure. 7: Shows instructions to read the response of the label pouch with temp-time indicator.
Figure. 8: Show the labels progress over a period of time at 370C incubation.

DETAILED DESCRIPTION OF THE INVENTION
The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments. This description is not intended to be a detailed catalogue of all the different ways in which the invention may be implemented, or all the features that may be added to the instant invention. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. In addition, numerous variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the scope of the instant invention. Hence, the following descriptions are intended to illustrate some particular embodiments of the invention, and not to exhaustively specify all permutations, combinations, and variations thereof.
The terms “for example” and “such as,” and grammatical equivalences thereof, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise.
As used herein, the term “about” is meant to account for variations due to any experimental errors which may be commonly accepted in the field for a numeric value, for example such a variation can be considered as a ±10% of the said numeric value. All measurements reported herein are understood to be modified by the term “about,” whether or not the term is explicitly used, unless explicitly stated otherwise. Further for the purposes of the present invention, ranges may be expressed as from “about” one particular value to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value to the other particular value. The recitation of numerical ranges by endpoints includes all the numeric values subsumed within that range.
As used herein, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Methods and materials are described herein for use in the present disclosure; other suitable methods and materials known in the art can also be used. The materials, methods and examples are illustrative only and not intended to be limiting by any means. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. In case of a conflict, the present specification, including definitions, will control.
Throughout this specification, unless the context requires otherwise the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated element or step or group of elements or steps but not the exclusion of any other element or step or group of elements or steps.
The term “including” is used to mean “including but not limited to”, “including” and “including but not limited to” are used interchangeably.
As used herein, the term “temp-time Indicator” or “time-temp Indicator” are used interchangeably within the meaning of the present specification, and refers to the integrated temp-time Indicator, integrated onto a single layer of flexible sheet, where the assembly of sheet into a pouch, and include a wicking sheet and an absorption sheet, according to present invention method leads to a highly durable, and cost-effective Temp-Time Indicator label pouch.
The phrase “wicking sheet” as used herein refers fabric materials, which are selected based on their ability to absorb liquids and acts as a reservoir for temperature-sensitive dyes such as oils, or high polar solvents, and absorb oil-based aerosols.
The phrase “absorption sheet” as used herein refers to paper materials, which are selected based on their ability to diffuse liquids, oils, or high polar solvents, and sometimes absorb oil-based aerosols. The rate of diffusion is controlled by the temperature of the product environment.
The present invention relates to a flexible label pouch designed for time-temperature indication. The label pouch consists of a single, flexible sheet that is transparent to semi-transparent, and has fold markings on both sides. These markings define the fold dimensions and boundaries to facilitate the creation of the pouch. The innovative aspect of this pouch lies in its folded structure, which makes it versatile and easy to integrate into various temperature-sensitive products.
In some embodiments the primary functionality of the label pouch according to the present invention is its ability to monitor temperature changes and indicate shelf life through a visual display. The key feature is the temperature-sensitive material integrated into the pouch. Upon exposure to specific temperatures, the material undergoes a solid-to-liquid phase transition, leading to color change or diffusion, which is easily noticeable by users.
In one related aspect of the above embodiments the present invention includes a mechanism for controlling the rate of diffusion of temperature-sensitive dyes or indicators. The flexible sheet comprises two essential layers: a wicking sheet and an absorption sheet. The wicking sheet serves as a reservoir for temperature-sensitive materials, such as oils, while the absorption sheet regulates the diffusion rate based on the ambient temperature. This ensures that the indicator not only tracks a temperature breach but also displays how long the product has been exposed to that temperature, providing a cumulative visual indication.
In one preferred embodiment, the label pouch according to the present invention is activated by unfolding the second fold of the flexible sheet, which initiates the diffusion process. The folds are strategically designed to keep the components inactive until the sheet is fully unfolded. This feature reduces human error during the activation process and ensures that the time-temperature indication begins only when the product is in use.
In some embodiment the present invention provides a flexible label pouch comprising of a printed and flexible sheet, wherein the pouch is characterised by a:
- first fold in forward direction at 1/4th of the sheet;
- a second fold in backward direction at the half of the sheet;
- aligned and matched top and bottom edges of the sheet;
wherein the bottom edge of the sheet is sealed first followed by left edged and the ride side edge, and unfolding the first fold leads to the activation of the label pouch.
In one aspect according to the above embodiment the said label pouch comprises a major cavity and one minor cavity. In a related aspect the said minor cavity can be filled with a wicking sheet, whereas the major cavity can be filled with an absorption sheet.
In one aspect of the above embodiment the size of the said wicking sheet is 3/4th of the minor cavity size.
In one aspect of the above embodiment the size of the said absorption sheet is half of the major cavity size.
In yet another aspect according to the above embodiment in the said label pouch the front side may be printed with text and graphics including folding instructions, and the back side may be attached to a double side tape to adhere to any substrate of interest and the said back side may be left blank.
In a further aspect the label pouch according the present invention is typically of dimensions:
- Before the unfold from the first fold: length between about 1cm to about 11cm, preferably between about 2 cm to about 6 cm, width between about 0.8 cm to about 5 cm, preferably between about 1 cm to about 2.5 cm;
- After the unfold from the first fold: length between about 1.5 cm to about 15 cm, preferably between about 2 cm to about 8 cm, width between about 0.8 cm to about 5 cm, preferably between about 1cm to about 2.5 cm.
In one aspect the unfolding of the label pouch leads to the activation of the label pouch.
In some aspects according to the above embodiment, in the said label pouch the flexible sheet is a transparent to semi-transparent sheet, printed with markings of folding instructions. In a related aspect the said flexible sheet thickens ranges is between about 35 GSM to about 260 GSM, preferably between about 40 GSM to about 120 GSM.
In one aspect according to the above embodiment, in the said label pouch the flexible sheet sealing may be done by a heat seal, laser seal, or adhesive seal.
In some embodiment the present invention provides a flexible label pouch-based temperature time indicator comprising of a printed and flexible sheet, wherein the pouch is characterised by a:
- First fold in forward direction at 1/4th of the sheet;
- A second fold in backward direction at the half of the sheet;
- Aligned and matched top and bottom edges of the sheet;
Wherein the bottom edge of the sheet is sealed first followed by left edged and the ride side edge, and unfolding the first fold leads to the activation of the label pouch.
In one aspect according to the above embodiment the said label pouch comprises a major cavity and one minor cavity. In a related aspect the said minor cavity is filled with a wicking sheet, whereas the major cavity is filled with an absorption sheet.
In one aspect of the above embodiment the size of the said wicking sheet is 3/4th of the minor cavity size.
In one aspect of the above embodiment the size of the said absorption sheet is half of the major cavity size.
In yet another aspect according to the above embodiment in the said label pouch the front side may be printed with text and graphics including folding instructions, and the back side may be attached to a double side tape to adhere to any substrate of interest and the said back side may be left blank.
In a further aspect the label pouch integrated with temp-time indicator according the present invention is typically of dimensions:
- Before the unfold from the first fold: length between about 1cm to about 11cm, preferably between about 2 cm to about 6 cm, width between about 0.8 cm to about 5 cm, preferably between about 1 cm to about 2.5 cm;
- After the unfold from the first fold: length between about 1.5 cm to about 15 cm, preferably between about 2 cm to about 8 cm, width between about 0.8 cm to about 5 cm, preferably between about 1cm to about 2.5 cm.
In some aspects according to the above embodiment, in the said label pouch the flexible sheet is a transparent to semi-transparent sheet, printed with markings of folding instructions. In a related aspect the said flexible sheet thickens ranges is between about 35 GSM to about 260 GSM, preferably between about 40 GSM to about 120 GSM.
In one aspect according to the above embodiment, in the said label pouch the flexible sheet sealing may be done by a heat seal, laser seal, or adhesive seal.
In some embodiments according to the present invention the disclosure also provides method of creating the label pouch, wherein in the said method flexible sheets are characteristically used involving the following steps:
(i) the flexible sheet is folded forward at 1/4th of its length, creating the first fold;
(ii) the second fold is made in the backward direction at the half mark of the sheet;
(iii) the open edges of the folded sheet are sealed using heat lamination, which forms the pouch structure.
wherein the said method ensures the formation of a compact, easily deployable indicator that activates upon unfolding.
In one aspect the label pouch integrated temp-time indicator is activated by the unfolding of the label pouch.
In one aspect of the above embodiment the label pouch is sealed first at the bottom edge and at the left side edge followed by sealing at the right-side edge.
In yet another aspect of the above embodiment in the said label pouch the front side of the label pouch may be printed with text and graphics (including folding instructions), whereas the back side may be attached to a double side tape to adhere to any substrate of interest.
In one aspect according to the above embodiment in the said method the label pouch comprises a major cavity and one minor cavity. In a related aspect the said minor cavity is filled with a wicking sheet, whereas the major cavity is filled with an absorption sheet.
In one aspect of the above embodiment the size of the said wicking sheet is 3/4th of the minor cavity size.
In one aspect of the above embodiment the size of the said absorption sheet is half of the major cavity size.
Furthermore, the pouch according to the invention can be adhered to products to be monitored using double-sided adhesive for continuous monitoring.
In some embodiments according to the present invention, the disclosure provides methods of using the label pouch for temperature-sensitive products including the steps of:
- applying the unfolded pouch to the product, such as food, vaccines, or chemicals;
- the label monitors the cumulative exposure to temperature and provides a visual cue through color change or diffusion, based on the temperature-sensitive material; and
- this ensures the perishable goods remain within their safe usage window, minimizing wastage,
wherein such unfolding of the pouch activates the temperature time indicator of the label pouch.
In one embodiment, the label pouch prepared according to the present invention is used to prevent the spoilage of perishable food items. The time-temperature indicator can be integrated into packaging for frozen or refrigerated goods, offering real-time monitoring of temperature breaches that could compromise food safety.
In another embodiment, the label pouch prepared according to the present invention is applied to vaccines, ensuring they remain within the recommended temperature range during storage and transportation. The indicator provides a clear visual alert when temperature limits are exceeded, helping healthcare providers maintain vaccine efficacy.
In some embodiments according to the present invention the label pouch with integrated temp-time indicator is prepared by a particular process that includes:
- the selection of temperature-sensitive dyes or oils that react to heat;
- the folding and sealing of the flexible sheet to contain the indicator components;
- the activation of the indicator by unfolding, which leads to color change or diffusion based on the temperature breach;
wherein by integrating this innovative process into the production of flexible label pouches, the invention provides a cost-effective, reliable, and durable solution for monitoring temperature-sensitive products across various industries.
In some embodiments according to the present invention the preparation of the temperature-time Indicator comprises several key steps, including:
• folding the flexible sheet in a specific sequence to create distinct cavities;
• filling the minor cavity with a wicking sheet that holds the temperature sensitive material;
• filling the major cavity with an absorption sheet that regulates the rate of flow of the temperature sensitive material;
• incorporating an oil mixture into the minor cavity followed by aligning and matching the top and bottom edges of the sheet and sealing along the right-side edge to achieve a temp-time indicator,
wherein the folding step includes a first folding at 1/4th of the sheet and a second folding at the half of the sheet, wherein the said first folding is in forward direction and the second folding is in backword direction.
In some aspects of the above embodiment, the said method of using the temperature-time indicator includes the step of unfolding the pouch from the first fold for activation of the indicator. This action initiates a time dependent diffusion process, allowing the temperature-sensitive materials to become activated and start indicating temperature exposure with cumulative time upon the temperature breach.
The label pouch or the label pouch integrated temp-time indicator according to the present invention has a label pouch dimension:
- Before the unfold from the first fold: length between about 1 cm to about 11 cm, preferably between about 2 cm to about 6 cm, width between about 0.8 cm to about 5 cm, preferably between about 1 cm to about 2.5 cm.
- After the unfold from the first fold: length between about 1.5 cm to about 15 cm, preferably between about 2 cm to about 8 cm, width between about 0.8 cm to about 5 cm, preferably between about 1 cm to about 2.5 cm.
In another aspect of the above embodiment the dimensions of the wicking and absorption sheets can be tailored for efficiency:
- the wicking sheet may occupy 3/4th of the minor cavity, ensuring a tight space for the temperature-sensitive oil;
- the absorption sheet may be designed to occupy half of the major cavity, ensuring a tight space to avoid any moisture intake as well as reduce air trap.
In another related aspect of the above embodiment, in the method for preparing the oil for the temperature-time indicator includes the following:
- utilizing a composite of natural dyes, additives, and a speciality compound, for preparation of the oil, wherein the:
a. natural dye in the composition is present at 1 to 5% by weight;
b. the additive comprising 3 to 10% by weight; and
c. speciality compounds comprising 10 to 70% by weight.
Exemplary components used in the present invention comprises:
The flexible sheet used in the present invention is made from the group comprising of Polyolefins selected from low-, linear low-, and high-density polyethylene (LDPE, LLDPE, HDPE), polypropylene (PP), and biaxially oriented polypropylene (BOPP); copolymers of ethylene, like ethylene-vinyl acetate (EVA), ethylene-vinyl alcohol (EVOH), and ethylene- acrylic acid (EAA); Nanocomposite polymers selected from polymer reinforced nanoparticles; substituted olefins selected from polystyrene (PS), high-impact polystyrene (HIPS, with 1,3-butadiene isomer added during the polymerization of the PS), oriented polystyrene (OPS), poly (vinyl alcohol) (PVOH), poly(vinyl chloride) (PVC), and poly(vinylidene chloride) (PVdC), and poly(tetrafluoroethylene) (PTFE); polyesters selected from polyethylene terephthalate (PET), polyethylene naphthalate (PEN), and relative copolymer PET-PEN; polycarbonates (PC); Polyamide (PA); Acrylonitriles, selected from polyacrylonitrile (PAN) and acrylonitrile/styrene (ANS); Regenerated cellulose; polylactic acid (PLA) as biodegradable polymer for food packaging contact; and Plasma pre-treated polymers.
The flexible sheet according to the present invention is a transparent to semi-transparent sheet, printed with markings of folding instructions.
The flexible sheet according to the present invention has a thickness between about 35 GSM to about 260 GSM, preferably between 40 GSM to about 120 GSM.
The flexible sheet according to the present invention is sealed to make the pouch, wherein the sealing can be a heat sealing, laser sealing, or adhesive sealing.
The wicking sheet used in the present invention is made from the group comprising of Polypropylene (PP) fabrics, Polyethylene (PE) nonwoven fabrics, Nylon fabrics, Silk fabrics, Tencel fibres, super absorbent treated polymer fabrics, Rayon fabrics, Polyester fabrics, Spunbond polypropylene fabrics, Teflon coated nylon, Microfiber fabric blends nylon and polyester, and PPE (Personal Protective Equipment) filter cloths.
The absorption sheet used in the present invention is made from the group comprising of: Genuine Ivory paper, Virgin paper, Ivory linen paper, Cream paper, Eggshell paper, Antique white paper, Natural white paper, Parchment paper, Buff paper, Linen paper, Sand paper, Ecru paper, and Beige bond paper.
The oil used in the present invention is a composite of natural dyes, an additive; and at least one selected from the speciality compounds selected from Propyl Butyrate, Phytanic Acid Methyl Ester, Isopropyl Myristate, Propyl Esters, Ethyl Valerate, Diethyl Sebacate, Ethyl Undecanoate, Ethyl Stearate, Eicosapentaenoic Acid, Methyl Butyrate, Methyl Anthranilate, Methyl Valerate, Methyl Laurate, Diethyl Sebacate, Benzene, Methyl Myristate, Tetradecane, Sodium Acetate Trihydrate, Pentadecane, Hexadecane, Lauric Acid Mixture (Fatty Acid), Ammonium Nitrate, Camphor, Octane, Caprylic Acid (Octanoic Acid), Acetamide Mixtures, Formamide, 2,2,4-Trimethylpentane (Isooctane), Dodecane, Trimyristin, Nitrobenzene, Butyric Acid, Methyl Palmitate, 1,2-Propylene Glycol, Cyclohexane, Calcium Chloride, Sodium Thiosulfate Pentahydrate, Ammonium Nitrate, Choline Chloride-Urea Mixture, Ethylammonium Nitrate, Imidazolium-Based Ionic Liquids, Ammonium Acetate Solutions, Dimethyl Sulfoxide (DMSO)-Water Mixture, 1,2-dibromo-3- chloropropane, 1-bromo-n-tridecane, 1-bromo-n-tetradecane, 1-ethoxy naphthalin, 12-hydroxy-9-octadecanoic acid, 2-Acetamidoethanethiol, 2-Methoxyaniline, 2-butanol,3,3,-dimethyl-, 3-chloro-(1,1 biphenyl)2-ol, 4-methyl-2-methoxyphenol, Acetamide-2,2- dichloro-N, n-di-2-propenyl-, Benzene 1,1-(1,3-propanediyl)bis, Benzene ,1,4,-Di-bromo-2-methyl, Butane, 1,4-Diiodo-, Butanoic acid,3,3-dimethyl, Heptadecane 2-methyl, Neopentyl glycol diacrylate, Nitrobenzene, O-bromophenol, Octadec-9-enoic acid ethyl ester, Tris (2,3-di bromo propyl)phosphate, Undec -9-en-1-ol.
The natural dye used in the present invention is selected from the group comprising of: Turmeric, Beetroot, Indio, Avocado Pits and Skins, Onion skins, Walnut Husks, Madder Root,, Red Cabbage, Pomegranate Rinds, Hibiscus, Red sandalwood, Lichen, Leuco dyes, Anthocyanin, and Logwood.
The additives used in the present invention is selected from the group comprising of: Polyethylene Glycol, Poly(N-isopropylacrylamide), Polyvinyl Alcohol, Cellulose, Polystyrene-b-polyethylene oxide, Polyethylene Glycol-Polyethylene- Polyethylene Glycol, Eutectic compounds, Gelatin, and Paraffin wax, and Glycerol.
Some of the regular application of the flexible temp-time indicator pouch according to the present invention includes:
a) Food Packaging Applications: The label pouch can be utilized in food packaging to monitor temperature exposure during transportation and storage. By adhering the pouch to food packaging, consumers can visually assess the product's safety and quality based on the indicator's readings.
b) Pharmaceutical Applications: The temperature-time indicator may be used with temperature-sensitive medications and vaccines. This embodiment ensures that healthcare providers can quickly determine the viability of a product based on its exposure to temperature extremes.
c) Logistics and Transportation: In logistics, the label pouch can be applied to containers carrying temperature-sensitive goods. The indicator provides real-time monitoring, alerting handlers to any temperature breaches that could compromise the contents, thus minimizing waste and ensuring compliance with regulatory standards.

DETAILED DESCRIPTION OF FIGURE 1
Figure 1 illustrates the structure of the flexible sheet (10) used in the preparation of the label pouch (11). The flexible sheet (10) is designed in three distinct sections: the lower part (100), the middle part (200), and the upper part (300). Each part plays a crucial role in the folding, sealing, and functioning of the label pouch.
(a) Flexible sheet (10): The overall structure, which is a flexible, foldable material intended for creating the label pouch. It includes designated markings and edges for folding and sealing.
(b) Lower part of the sheet (100): This portion forms the base of the sheet.
- Lower part, upper edge (101): This edge defines the top boundary of the lower part (100).
- Lower part, bottom edge (102): The lower boundary of the lower part of the sheet (100), which becomes one of the key sealing points during pouch formation.
- Lower part, sealing edge (103): This edge indicates the section where sealing occurs to close the label pouch, specifically on the bottom and left side of the flexible sheet.
(c) Middle part of the sheet (200): The middle portion connects the lower (100) and upper parts (300) of the sheet. It is critical for aligning the sheet during the folding process and contributes to forming the minor and major cavities within the pouch.
(d) Upper part of the sheet (300): This portion is on the top of the flexible sheet and serves as a crucial component in completing the pouch after folding.
- Upper part, top edge (301): The uppermost edge of the flexible sheet.
- Upper part, bottom edge (302): The edge that meets the middle part of the sheet during the folding process.
- Upper part, Line1 (303): A marked folding line located between the top and bottom edges, guiding the first fold in the pouch preparation.
- Upper part, Line2 (304): Another marked line to guide the second fold, which is crucial for creating the proper structure of the label pouch.
- Upper part, sealing edge (305): This edge indicates where sealing will occur on the right side of the flexible sheet during the assembly of the pouch.
- Upper part, left side sealing edge (306): The left boundary of the upper part, which aligns with the left side of the sheet and becomes a sealing point.
- Upper part, right side sealing edge (307): The right boundary of the upper part, sealed during the pouch creation process, ensuring the entire structure is securely enclosed.
Label Pouch (11): Once the flexible sheet (10) undergoes the described folding and sealing process according to the present invention, it transforms into the label pouch (11), which for application can be integrated with a temp-time indicator mechanism, leading to a label pouch integrated with temp-time indicator (22). The label pouch consists of a minor cavity (23) and a major cavity (24) formed by the strategic folding of the flexible sheet. This pouch is designed to display temperature breaches and time gradients, adhering securely to substrates.
The window is pre-printed with specified time intervals, allows the user to monitor the temperature breach, and cumulative time upon the temperature breach. Upon the temperature breach, the oil changes its phase from solid to liquid and diffuses along the absorption sheet.
The progress of the oil is indicative of the product temperature breach as well as the cumulative time upon the temperature breach. If the oil reaches to the final interval of the display window, it can be concluded that, the product can no longer be useful and the product reached to its end point. The end point is defined as per the application of the label pouch integrated with TTI, for example it can varies from 1hr at about 370C to 30 days at about 370C. In addition, the temperature breach in this context of the invention is defined as per the application of the label integrated with TTI and a fixed range, i.e., about 40C to about 80C.
The progress of the oil along the diffusion window and the time intervals is useful for consumers to estimate the product usefulness as well as how quickly to use the product before it gets non-functional or non-useful.
Also, another added advantage of the present invention is that the label pouch made as Time-Temperature indicator does not require long term pre-conditioning, which eliminates the complex instructions of use and facialists to use the label on emergency events.

EXAMPLES:
The following examples include only exemplary embodiments to illustrate the practice of this disclosure. It will be evident to those skilled in the art that the disclosure is not limited to the details of the following illustrative examples and that the present disclosure may be embodied in other specific forms without departing from the essential attributes thereof, and it is therefore desired that the present embodiments and examples be considered in all respects as illustrative and not restrictive.

Example-1: Preparation of label pouch (11):
The process for constructing the label pouch (11) using the flexible sheet (10). The process is broken down and each step in the process, from the initial folds to the final formation of the label pouch, highlighting the role of each folding action and sealing process in the creation of the functional label pouch. (See at Figure. 2 flow chart illustration)
The exemplary process includes five main steps, each corresponding to a distinct action in folding and sealing the sheet to create the final label pouch (11).
Step 1: First fold in forward direction at the intersection of (101)
The process begins by folding the flexible sheet (10) forward at the intersection of the lower part's upper edge (101), at 1/4th of the sheet. This forward fold creates an initial alignment between the lower and middle parts of the sheet. The fold forms the base of the label pouch and sets the stage for the second folding action.
Step 2: Second fold in backward direction, where the fold intersects the middle of (301) and (302)
In this step, the sheet is folded backward, aligning the upper part (300) at the midpoint between its top edge (301) and bottom edge (302). This creates the pouch's minor (23) and major (24) cavities, essential for integrating the temp-time indicator. The backward fold also helps secure the flexible sheet’s structure for subsequent sealing steps.
Step 3: Heat sealing along the three sealing edges, (103), (305), (306) & (307)
After folding, heat sealing is performed along multiple edges of the flexible sheet to create a secure and closed label pouch. The sealing edges involved are:
- Lower part, sealing edge (103)
- Upper part, sealing edge (305)
- Upper part, left side sealing edge (306)
- Upper part, right side sealing edge (307)
These seals ensure that the label pouch is effectively enclosed, leaving a controlled environment for a temperature and time-sensitive indicator during use for the same.
Step 4: Label pouch by unfolding at the middle part of the sheet (200). Back side of the label pouch (400) for adhesive to fix.
After heat sealing, the label pouch is carefully unfolded at the middle part of the sheet (200) to reveal its final shape. The back side of the label pouch is indicated by the reference numeral (400), providing structural support for the pouch and its indicator system by attaching adhesive to fix the label on a designated place of use.
Step 5: Front side of the label pouch with display window (500)
The front side of the label pouch is indicated by (500). This section includes the display window (500), through which the temp-time indicator will be visible when integrated. The display window will allow users to monitor any changes in the temperature or time exposure of the product, making it a critical component of the label pouch. It can also be used to indicate time gradients, or graphics to showcase the function of the label pouch or application of the label pouch with their temperature sensitivity as well as cumulative time upon temperature breach.

Example-2: Preparation of “label pouch integrated with the temperature-time indicator” (22):
The label pouch’s preparation and integration with the temperature-time indicator in detail (in view of Figure-3 process flow), focusing on the folding, sealing, filling, and activation processes to ensure its proper functionality.
The step-by-step process for preparing the label pouch (11) and integrating it with the temperature-time indicator involves precise folding, sealing, and filling actions that ensure the proper functionality of the indicator, as well as the formation of distinct cavities within the pouch.
Step 1: First fold in forward direction at the intersection of (101)
The process begins with a forward fold at the intersection of the lower part’s upper edge (101). This initial fold creates the foundation for the label pouch by aligning the lower part (100) with the rest of the sheet.
Step 2: Second fold in backward direction, where the fold intersects the middle of (301) and (302)
In this step, the flexible sheet (10) is folded backward, intersecting at the midpoint between the upper part's top edge (301) and bottom edge (302). This fold helps form the upper portion of the label pouch and creates the structural divisions necessary for the cavities.
Step 3: Align and match the top and bottom edges, and seal along the two edges (103), (305) & (306), where minor (23) and major (24) cavities are formed. Once the folds are completed, the top edges (301) and bottom edges (102) are aligned, and sealing is performed along the following edges:
- Lower part, sealing edge (103)
- Upper part, sealing edge (305)
- Upper part, left side sealing edge (306)
These sealing actions secure the label pouch and result in the formation of two distinct cavities: a minor cavity (23) and a major (24) cavity.
Step 4: Fill the minor cavity (23) with a wicking sheet, and fill the major cavity (24) with an absorption sheet (24A), and finally fill the minor cavity with an oil. After sealing, the cavities are filled with essential components for the temperature-time indicator:
a) The minor cavity (23) is filled with a wicking sheet, which holds the oil.
b) The major cavity (24) is filled with an absorption sheet, which allows the diffusion of the oil along the sheet.
c) Additionally, a small fold is created at the back side of the indicator (22), which is visible after the activation of the indicator by overlaying the components of minor (23) and major (24) cavity.
Step 5: Seal along the right-side edge, (307)
After the filling process is completed, sealing is performed along the right-side sealing edge (307). This seals the entire structure and locks the wicking and absorption sheets inside the label pouch, preventing any leakage of the reactive components.
Step 6: Label by unfolding at the middle part of the sheet, (200). Back side of the label for adhesive fix, (400)
The ‘pouch integrated with temp time indicator’ (22) is then carefully unfolded at the middle part of the sheet (200) to finalize its shape. The back side of the label pouch (400) is prepared with an adhesive, allowing the label pouch to be fixed onto products. This back side also serves as a protective layer for the temperature-time indicator.
Step 7: Activated state with display window, (500) specified with time intervals
Before use of the label pouch integrated with temp-time indicator, it requires to be pre-conditioned at +4C for minimum of 30 minutes. Next, the ‘label pouch integrated with temp time indicator’ (22) is activated upon unfolding in step 6, revealing the front side with the display window (500) in step 7. The display window with pre-printed time – intervals reveal the diffusion rate of the oil along the absorption sheet, i.e., cumulative time upon the temperature breach of the product in use.

Example-2.1: Alternate preparation of label pouch integrated with the temperature-time indicator (22):
An alternate preparation process for the label pouch (11) along with the integration of the temperature-time indicator is followed. This method includes additional steps for attaching the absorption and wicking sheets before sealing and activation. (as outlined in process flow Figure 4)
Step 1: First fold in forward direction at the intersection of (101)
The preparation begins by folding the flexible sheet (10) forward at the intersection of the lower part’s upper edge (101). This fold creates the foundation for the pouch, with the lower part (100) positioned to receive the absorption sheet.
Step 1.1: Attach absorption sheet on the lower part of the sheet (100), 5 mm over the upper edge of (100)
In this step, an absorption sheet (24A) is attached to the lower part of the sheet (100), ensuring proper placement x mm over the upper edge (101). This absorption sheet will help diffuse the oil along the sheet depending on the temperature or time-sensitive reactions along the pouch environment.
Step 1.2: Attach a wicking sheet (23A) containing oil on the middle part of the sheet (200)
First, a wicking sheet (23A) is soaked in an oil before it is attached to the middle part of the sheet (200). This component is designed to act as a reservoir for the oil within the pouch, and helping to ensure a controlled release of the oil onto the absorption sheet, depending on the temperature of exposure.
Step 2: Second fold in backward direction, where the fold intersects the middle of (301) and 302
The sheet (10) is then folded backward at the intersection of the upper part’s top edge (301) and bottom edge (302). This fold creates the outer structure of the pouch and forms two separate compartments inside: one for the absorption sheet (24A) and one for the wicking sheet (23A).
Step 3: Heat sealing along the three sealing edges, (103), (305) & (306). This leads to non-activated state of the Temp-Time indicator ready for use, and back side of the label for adhesive to fix (400). After the folds are completed, a single step heat sealing is performed along three edges:
- Lower part, sealing edge (103)
- Upper part, sealing edge (305)
- Upper part, left side sealing edge (306)
This sealing step secures the structure of the label pouch, with the absorption and wicking sheets contained inside. At this point, the pouch remains in a non-activated state, and the back side of the label (400) is prepared.
Step 4: Label by un-folding at the middle part of the sheet, (200). Back side of the label for adhesive fix, (400)
The next step involves carefully unfolding the “pouch integrated with temp-time indicator” (22) at the middle part of the sheet (200) to reveal its final shape. The back side of the label (400) is equipped with an adhesive layer, enabling the pouch to be affixed to products. This step prepares the pouch for use, but it remains inactive until the final activation step.
Step 5: Activated state with display window, (500) specified with time intervals
The label pouch (22) is activated upon unfolding in step 4, transitioning to an activated state in step 5 where the display window (500) becomes visible and contains pre-printed time intervals. This window is crucial for monitoring the temperature or time-sensitive reaction, displaying time intervals as the reaction progresses. It provides a clear indication of whether the product has exceeded its allowed time or temperature exposure, ensuring accurate tracking.
The alternate method described in Example-2.1 (Figure 4) offers a variation in the preparation of the label pouch, focusing on pre-attaching the absorption and wicking sheets before the sealing process. The final activated state with the display window (500) remains consistent with the standard preparation method as in Example-2, providing the necessary functionality for the temperature-time indicator.

Example-3: Means for Use and interpretation of the label pouch integrated with the temperature-time indicator (22)
The Temp-Time indicator used to monitor temperature exposure over time, providing a visible indication if an item has been exposed to temperatures outside of recommended storage conditions. Therefore, both temperature as well as time are important parameters to define the indicator specifications. Note that, the display window (500) is printed with time intervals as well as instructions of the label.
Figure 5 illustrates the step-by-step process for using and interpreting the label pouch integrated with the temperature-time indicator (22). The figure highlights the activation mechanism and its visual representation through the display window (500).
Step 1: Peel Off the Transparent Layer
The transparent protective layer on the back side (400) of the label pouch is peeled off to expose the adhesive layer or prepare the label for activation. This ensures that the label is ready for the unfolding process.
Step 2: Unfold to Activate
The label pouch (22) is unfolded once in a forward direction to partially activate the temperature-time indicator. This initiates the interaction of components within the cavities, enabling the diffusion mechanism to begin.
Step 3: Unfold Again in the Same Direction
The label pouch (22) is further unfolded in the same forward direction to fully activate the system. This ensures that the components, including the wicking sheet, absorption sheet (24A), and oil, are aligned and functional to initiate the temperature-time tracking process.
Step 4: Activated Label
In the activated state, the label pouch is fully operational. The diffusion mechanism within the cavities begins to progress, and the time intervals printed on the display window (500) provide real-time feedback on elapsed time based on the rate of liquid diffusion.
Figure 5(a) depicts the unarmed or inactive state of the label pouch. In this state, the temperature-time indicator is inactive, and the display window (500) shows the printed time intervals along with user instructions for activation. This ensures clarity and ease of use for the end user, providing guidance on how to activate and interpret the label.
The Figure 6 shows how to interpret the response of the label pouch integrated with the temperature-time indicator. The Figure 6 interpretation is further elaborated in below Table 1:
Table-1: Instructions to interpret the response of the label pouch with temp-time indicator
Label Response Interpretation of the Label Response
Fig. 6(a) Activated label, i.e., unfolded label
- Red color in the First window upon Temperature breach
- If the expiry date has not passed, USE the product.
Fig. 6(b) - Red color in the second window means Temperature breach as well as x hr of time after breach
- If the expiry date has not passed, USE the product.
Fig. 6(c) - Red color in the Final window means Temperature breach as well as the End point exceed
- Do not USE the product

The display window also shows an extra advantage over competent TTI. The display window is printed with general instructions of the label as well as time intervals. The time intervals will guide the consumers to use the concerned product in due time before expiry or end point. Figure 6 shows how to read the time intervals on label pouch integrated with the temperature-time indicator.

Example 4: Working of Temp-time Indicator
Example 4(a): Working to TTI with Short time Interval
The trials were done with the label pouch with temp-time indicator to store items at +40C of breaching temperature with an end point of 2 hours at +370C and 11 hours at +250C.
The label pouch is prepared as specified in the Example 2, but the oil phase is tuned to achieve the desired time of 2 hours at +370C. The process of making the oil comprises of mixing of 1 ml of Nitro-Benzene to a red dye of 0.001 g, and stir for 30 min till the full dispersion. Later, add 0.05 g of Polyvinyl Alcohol is added and further stirred for 30 min. Using a micro pipet, 70µl of oil is poured into the minor cavity of the label pouch. Upon filling the minor cavity with the oil, the label pouch is heat sealed in the last edge. The label pouch is then stored at +40C for 40 min. Total of 10 label pouches are made to monitor the reproducibility and consistency of the label response.
After the pre-conditioning the label pouch, the labels are unfolded to active. The labels were then placed under incubator of 370C, and monitoring the window display of the label pouch. The Figure-8 shows the labels progress over a period of time at 370C incubator. The time to reach the final window of the label pouch is nothing but the end point of that particular product in study. The data shows consistency on last window of the product, where the time of diffusion of the oil is consistent over 10 products, 120min ± 3min.
Similar labels were further used to study the response at + 250C, the results show that, the final window of the label pouch reaches in 11 hours.
The results in this example show that the end point of the labels changes with respect to the storage temperature, i.e., higher the temperature, faster the label responds and the oil reaches to the final window. This label is useful for application in dairy products such as milk storage and transport.

Example 4(b): Working to TTI with long time Interval
To further evaluate the label pouch, the composition of the oil was changed to reach the long-time interval. The label pouch is prepared as specified in the Example 2.1. However, the oil phase comprises of mixing of 1 ml of Methyl Myristate to a red dye of 0.001 g, and stir for 30 min till the full dispersion. Later, add 0.1 g of calcium chloride in 0.5 ml of water, 0.028 g of polyethylene glycol, and 0.1 ml of glycol and further stir for 30 min. Using a micro pipet, 90 µl of oil is poured into the minor cavity of the label pouch. Upon filling the minor cavity with the oil, the label pouch is heat sealed in in all the edges as specified in Example 2.1. The label pouch is then stored at +4 0C for 60 min. Total of 10 label pouches are made to monitor the reproducibility and consistency of the label response.
After the pre-conditioning the label pouch, the labels are unfolded to active, as indicated in Example 3 (Figure 5). The labels were then placed under incubator of 37 0C, and monitoring the window display of the label pouch. The below table-2 shows the labels progress over a period of time at 370C incubator, as well as at 250C incubator, and also at +40C.
Table-2: Shows Labels progress over a period of time (370C, 250C & 40C)
Sample ID Hours / Days to Endpoint (Final window) at +37 oC Hours /Days to Endpoint (Final window) at +25 oC Hours / Days to Endpoint (Final window) at +4 oC
Exvit 2D-1 1 Day 22 hours 4 Days 18 hours No Response
Exvit 2D-2 1 Day 25 hours 5 Days 1 hour No Response
Exvit 2D-3 1 Day 23 hours 4 Days 22 hours No Response
Exvit 2D-4 1 Day 22 hours 5 Days 1 hour No Response
Exvit 2D-5 2 Days 5 Days 0.5 hour No Response
Exvit 2D-6 1 Day 22 hours 5 Days 1.5 hour No Response
Exvit 2D-7 1 Day 23 hours 4 Days 23 hours No Response
Exvit 2D-8 2 days 5 Days 0.5 hours No Response
Exvit 2D-9 1 Day 22 hours 4 Days 23 hours No Response
Exvit 2D-10 1 Day 23 hours 5 Days 0.5 hours No Response
ExviT is internal sample coding, and 2D – stands for 2 days.
The data shows consistency on last window of the product, where the time of diffusion of the oil is consistent over 10 products, 1 days 23 hours  1hour at 370C, and 4 days 22 hours  1hour at 250C. The labels show no response at +4 0C condition, due to the fact that there is no breach in temperature. This product may find applications in vaccines storage and transport, specific pharmaceutical drugs, to name a few examples.

Example 4(c): Working to TTI with and without pre-conditioning, and time of pre-conditioning
To further test the importance of the time of pre-conditioning of the labels before use, three different batches were made with below conditions:
Batch-01: Labels made without pre-conditioning,
Batch-02: Labels made with pre-conditioning at +40C for 30 min,
Batch-03: Labels pre-conditioned at +40C for 120 min.
The specification of the labels is set to reach end point (final window) at 370C in 30 min.
Sample ID Minutes/Hours / Days to Endpoint (Final window) at +37 oC Minutes /Hours / Days to Endpoint (Final window) at +25 oC Minutes/Hours /Days to Endpoint (Final window) at +4 oC
Exvit_1 PC 0 min 3 minutes 5 minutes 7 minutes
Exvit_2 PC 0 min 3.5 minutes 7 minutes 9 minutes
Exvit_3 PC 0 min 3 minutes 5.5 minutes 7.5 minutes
Exvit_1 PC 30 min 31 minutes 121 minutes No Response
Exvit_2 PC 30 min 30 minutes 123 minutes No Response
Exvit_3 PC 30 min 29 minutes 119 minutes No Response
Exvit_1 PC 120 min 32 minutes 122 minutes No Response
Exvit_2 PC 120 min 29 minutes 120 minutes No Response
Exvit_3 PC 120 min 30 minutes 121 minutes No Response
ExviT is internal sample coding, and PC – stands for pre-conditioning.
The test confirms that, 30 min of pre-conditioning is enough to attain repeatable results.

Example 5: Comparative Example to depict the importance of steps for making the label pouch
The time interval i.e., diffusion properties of the oil along the absorption sheet of the time-temp indicator is controlled by the components of oil. The time intervals may be termed as end point or discarding point, which is seen as the oil fills the final window of the Temp-Time indicator.
Different oils compositions were are made to achieve different endpoints between 2 minutes up to several days depending on the storage temperatures.
Table-3 lists the combination of oil components on the end point at 370C. However, the same oil components will give higher endpoint as storage temperature is low.
Table-3: Data with different combination of oil composition and time to endpoint
Sample ID Oil composition Minutes/Hours / Days to Endpoint (Final window) at +37oC
ExviT -2 M 1 ml of Nitro-Benzene, red dye of 0.001 g 2 minutes
ExviT -30M 0.1 ml of Benzene, red dye of 0.001 g, 0.01 g of Polyvinyl Alcohol. 30 minutes
ExviT 2H 1ml of Nitro-Benzene, red dye of 0.001 g, 0.05 g of Polyvinyl Alcohol. 2 hours
ExviT 1D 1.5 ml of Butane, red dye of 0.001 g, 0.01 g of polyethylene glycol. 1 Day
ExviT 2D 1 ml of Methyl Myristate, red dye of 0.001 g, 0.028 g of polyethylene glycol, 0.01 g of Calcium Chloride in 0.5ml of water, and 0.1 ml of glycol 2 Days
ExviT 3D 0.5 ml of Eicosapentaenoic Acid, Red dye of 0.001 g, 0.1 g of Cellulose, and 0.5 ml of Polyethylene Glycol. 3 Days
ExviT 5D 1.5ml of Caprylic Acid, 0.05 g of Gelatin, 0.001 g of red dye, and 0.01 g of Paraffin wax. 5 Days
ExviT 7D 1.05 ml of Isopropyl Myristate, 0.05 g of Gelatin, 0.001 g of red dye, and 2.5 ml of Polyethylene Glycol, and 0.01 g of Paraffin wax. 7 Days
ExviT 14D 1.05 ml of Isopropyl Myristate, 2.5 ml of Nitro-Benzene, 0.05 g of Lauric Acid, 0.05 g of Gelatin, 0.001 g of red dye, 0.01 g of Polyethylene Glycol-polyethylene- Polyethylene Glycol, and 0.9 ml of Glycerol, and 0.01 g of Paraffin wax. 14 Days
ExviT 20D 1.05 ml of Isopropyl Myristate, 2.5 ml of Nitro-Benzene, 0.05 g of Lauric acid, 0.05 g of Gelatin, 0.01 g of 0.02 g of Polyethylene Glycol-polyethylene- Polyethylene Glycol, 0.001 g of red dye, and 0.9 ml of Glycerol, and 0.01 g of Paraffin wax. 20 Days
ExviT is internal sample coding, and M, H & D – stands for minute, hour and day respectively.

Example 6: Comparative Example to depict the importance of steps for making the label pouch
To further evaluate the label pouch making process and importance of folding steps, a label has been made without following the step 1 in Figure 3 or Figure 4. The flexible sheet is folded exactly at the mid of part 200, not folding at 1/4th but at ½ of the sheet. By following the step method in Figure 3, two of the label edges are sealed first, which makes only a single cavity. The cavity is then filled first by wicking sheet followed by absorption sheet. Finally, filled the cavity with oil (oil composition same as specified in Example 4(b)) on the wicking sheet, followed by seal on the open edge. Due to a single cavity, the components were mixed and already activated as soon as oil is added to the label. The label reaches to an end point in 1 min as soon as it is final sealed. Therefore, it is important to implement all the steps of Figure 3 or Figure 4.
Indeed, another label pouch was made by not folding at 1/4th but at 1/3rd of the sheet. Rest of the steps are same as in Figure 3. Likewise, a single cavity was formed, which is then filled first by wicking sheet followed by absorption sheet. Finally, filled the cavity with oil (same oil composition as specified in Example 4(b)) on the wicking sheet, followed by seal on the open edge. Due to a single cavity, the components were mixed and already activated as soon as oil added to the label. The label reaches to end point in 1 min as soon as it is final sealed. Therefore, it is important to implement all the steps of Figure 3 or Figure 4.

, Claims:WE CLAIM:
1. A label pouch (11) comprising:
a flexible sheet (10) characterized by having a lower part (100), a middle part (200), and an upper part (300);
a first fold in a forward direction at approximately 1/4th of the flexible sheet (10) at the intersection of the upper edge (101) of the lower part (100);
a second fold in a backward direction at approximately half of the flexible sheet (10) at the intersection of the top edge (301) and bottom edge (302) of the upper part (300);
sealing along the bottom edge (103) and the left side edge (306) to form a pouch structure configured to have a minor cavity (23), and a major cavity (24);
alignment and matching of the top edge (301) and bottom edge (102) after the folds, with sealing along the right-side edge (307) to complete the pouch structure.
2. The label pouch as claimed in claim 1, wherein the pouch is configured to contain multiple compartments for holding separate materials in the minor (23), and major (24) cavities.
3. The label pouch as claimed in claim 1, wherein the flexible sheet (10) is formed of a heat-sealable material that allows the sealing edges to maintain structural integrity during use.
4. The label pouch as claimed in claim 1, further comprising sealing on three open edges to prevent leakage between the minor, and major cavities after sealing.
5. The label pouch as claimed in claim 1, wherein the flexible sheet includes predefined folds that allow the pouch to be un-folded and re-folded while maintaining the integrity of the sealed cavities.
6. The label pouch as claimed in claim 1, further comprising an adhesive layer on the back side (400) of the label pouch for affixing the pouch to various surfaces.
7. A label pouch with integrated temperature-time indicator (22), comprising a flexible sheet (10) characterised by:
having a lower part (100), a middle part (200), and an upper part (300);
a first fold in a forward direction at approximately 1/4th of the flexible sheet (10) at the intersection of the upper edge (101) of the lower part (100);
a second fold in a backward direction at approximately 1/2th of the flexible sheet (10) at the intersection of the top edge (301) and bottom edge (302) of the upper part (300);
sealing along the bottom edge (103) and the left side edge (306) to form a pouch structure, where the label pouch is configured to have a minor cavity (23) for containing a wicking sheet (23A), a major cavity (24) for containing an absorption sheet (24A);
alignment and matching of the top edge (301) and bottom edge (102) after the folds, with sealing along the right-side edge (307) to complete the pouch structure and enable the functioning of the temperature-time indicator.
8. The label pouch as claimed in claim 7, wherein the absorption sheet (24A) is positioned in the major cavity of the pouch and is adapted to absorb oil to trigger the temperature-time indicator by diffusion of oil along the sheet.
9. The label pouch as claimed in claim 7, wherein the wicking sheet (23A) is positioned in the minor cavity which is also filled with oil, and is configured to regulate oil flow between the minor cavity (23) and the absorption sheet (24A) in the major cavity (24).
10. The label pouch as claimed in claim 7, wherein the oil is contained in the minor cavity to initiate a solid-to-liquid transition for controlling diffusion within the temperature-time indicator.
11. The label pouch as claimed in claim 7, wherein the display window (500) is integrated into the front side of the pouch, displaying time intervals based on the rate of oil diffusion on the absorption (24A) sheets.
12. The label pouch as claimed in claim 7, further comprising sealing on three open edges to prevent leakage between the minor, and major cavities after sealing.
13. The label pouch as claimed in claim 7, further comprising an adhesive layer on the back side (400) of the label pouch for fixing the pouch onto a product surface.
14. A method for preparing a label pouch with integrated temperature-time indicator (22), comprising:
folding a flexible sheet (10) in a forward direction at approximately 1/4th of the sheet at the intersection of the upper edge (101) of the lower part (100);
folding the flexible sheet in a backward direction at approximately 1/2th of the sheet at the intersection of the top edge (301) and bottom edge (302) of the upper part (300);
sealing the flexible sheet along the bottom edge (103) and the left side edge (306) to form a pouch structure with a minor cavity, and major cavity;
filling the minor cavity (23) with a wicking sheet (23A);
filling the major cavity (24) with an absorption sheet (24A); and finally
filling the minor cavity (23) with an oil-based indicator material;
aligning and matching the top edge (301) and bottom edge (102) after the folds;
sealing along the right-side edge (307) to complete the pouch structure and activate the temperature-time indicator.
15. The method as claimed in claim 14, wherein the absorption sheet (24A) is positioned within the major cavity (24) of the flexible sheet before sealing the bottom edge and left side edge.
16. The method as claimed in claim 14, wherein the wicking sheet (23A) is positioned in the minor cavity (23) before sealing the bottom and left edges.
17. The method as claimed in claim 14, wherein the oil-based indicator material is selected for its solid-to-liquid transition properties, facilitating diffusion to the wicking sheet (23A).
18. The method as claimed in claim 14, wherein sealing the right-side edge (307) completes the structure, ensuring the integrity of the temperature-time indicator.
19. The method as claimed in claim 14, wherein un-folding the flexible sheet at the middle part (200) activates the temperature-time indicator.
20. The method as claimed in claim 14, wherein the display window (500) is integrated into front side of the pouch, displaying time intervals based on the rate of oil diffusion on to the absorption sheet (24A).
21. The method as claimed in claim 14, further comprising an alternate preparation step wherein the absorption sheet (24A) is attached to the lower part (100) of the sheet and the wicking sheet (23A) is attached to the middle part (200) of the sheet prior to folding and sealing.

Dated this 26th Day of November, 2024

Biswajit Biswal
[IN/PA-2659]
Agent for the Applicant