Cold chain monitoring technologies. Product monitoring

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1 Cold chain monitoring technologies Product monitoring

2 Cost effective & Reliable Temperature Indicators to suit Single and Multiple unit level product monitoring Temptime Corporation, USA is the world's leading provider of scientifically based, time-temperature indicators. Temptime offers a wide range of timetemperature indicators devices. A specific color change of the device indicates to patients, doctors, healthcare professionals, manufacturers and distributors that the medical product has been exposed to potentially damaging heat and/or freeze events, the major risks for every Time Temperature Sensitive Pharmaceutical Product (TTSPP). Undetected heat or freeze damage creates the potential for less effective drugs to be administered to patients. Breaks in the cold chain affecting product quality increase as products move from manufacturer to patient administration. An innovative heat indicator of Temptime called the VVM is the first indicator used to monitor temperature-sensitive vaccines by global health organisations including WHO, UNICEF and several countries' Ministries of Health. World Leaders in Time Temperature Indicators Indicators for temperature monitoring at Single & Multiple unit levels Protecting Patients Reducing Risk Level of Monitoring Cumulative Time Temperature Indicator ( TTI ) Time delay Heat Excursion Threshold Indicator Freeze event Indicator Instantaneous Heat Excursion Threshold Indicator HEATmarker LIMITmarker FREEZEmarker LIMITmarker I Single unit level 40 TransTracker H TransTracker F TransTracker C TransTracker D Multiple unit box / shipper level Features Irreversible Instantaneous heat excursion identification Single-use Easy to read Easy to understand Device activation not required Superior monitoring reliability Nontoxic materials used in product 1 Benefits Identify and avoid administration of heat damaged medications to patients Extend quality control and risk management from production to patient Enhance quality risk management and support continual quality improvement Strengthen conformance to international code on Harmonization (ICH) Q9 and Q10 Reduce unnecessary waste - limit the destruction of products incorrectly suspected of heat damage Environmentally friendly.

3 Protecting Patients Reducing Risk World Leaders in Time Temperature Indicators Cumulative Time Temperature Indicator ( TTI ) for monitoring cumulative heat exposure from manufacturer to the end user Active Square Center Reference Colour Ring What is HEATmarker? It is a miniaturized, self-adhesive indicator that is affixed by the medical product manufacturer to individual units of temperature sensitive medical products. HEATmarker monitors storage and handling of products until the time of use and signals if a specific temperature profile of the product has been reached. The HEATmarker contains a square area of color-changing material (Active Surface) surrounded by an area of fixed color (Surrounding Surface). It is light in colour at the start and progressively and irreversibly darkens as the product is exposed to heat over time. When the color of the square matches or is darker than the surrounding circle, the HEATmarker indicator is showing that the product has been exposed to potentially damaging heat and it must not be used. HEATmarker is Correlated to the stability of your product HEATmarker develops color to reflect the way many biopharmaceuticals & diagnostic reagents degrade as they are exposed to heat : faster at higher temperatures and slower at lower temperatures, following Arrhenius Kinetic Principles. The HEATmarker is a mean kinetic temperature (MKT) indicator. The MKT is the best scientific way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. The HEATmarker is based on scientifically proven principles and patented technology. The rate of color development is correlated to the heat stability of the product to which the HEATmarker is affixed. There are more than 20 standard HEATmarker categories that can monitor a wide range of mean kinetic temperature profiles. 2

4 World Leaders in Time Temperature Indicators Protecting Patients Reducing Risk HEATmarker A simple and visible quality tool to monitor vaccines, biopharmaceuticals, diagnostic kits... Easy to read and understand. Provides irreversible, accurate results. Indicates if product should be used or not. Hence it indicates intelligent shelf life related to Cumulative heat exposure of the product. Cumulative Time Temperature Indicator ( TTI ) in single unit format A Self Adhesive Indicator is supplied in a roll for easy application on automatic labeling machine. HEATmarker can be applied on a variety of surfaces e.g. Side label, flip off seal, prefill-syringes etc. With a choice of more than 20 standard categories there is a Cumulative Time Temperature Indicator meeting the Mean Kinetic profile of your product. Cumulative Time Temperature Indicator ( TTI ) in Transtracker format Transtracker H, a customized card with HEATmarker indicator is also available as self adhesive stickers. Transtracker H cards are placed inside the multiple unit box to monitor the temperature exposure. Transtracker H stickers are fixed on the single unit boxes like Diagnostic kits, medical devices etc. Specification and performance Response temperature MKT indicator formulated to match stability of medical product C Storage temperature < -24 C Shelf life 4 years No activation required Temperature monitoring Continual Ordering Information- Please contact Lisaline team for selection of the appropriate HEATmarker. 3

5 Protecting Patients Reducing Risk World Leaders in Time Temperature Indicators LIMITmarker Time delayed Heat Excursion Threshold Indicator What is LIMITmarker? LIMITmarker is threshold Indicator for short term storage and transport monitoring of multiple unit box / shipper. Single-use threshold indicators irreversibly change color from white to red to signal that a heat excursion has occurred for a short period of time. LIMITmarker indicators are available with threshold heat response temperatures of 9 C and 25 C LIMITmarker is a simple, cost effective device to monitor Temperature sensitive medical products in multiple boxes & shippers. LIMITmarker has built in time delay component. This can eliminate the possibility of a premature response during standard handling procedures. Hence leading medical product manufacturers and distributors use LIMITmarker to ensure compliance with regulatory guidelines, extend their quality systems into the distribution system and communicate their commitment to cold chain best practices. Ok Over heated Window showing colour change LIMTmarker self adhesive indicators Transtracker F with LIMITmarker indicators Specifications & Performance Response Temperature 9 C, 25 C, 31 C ±1 C Storage Temperature Frozen -6 C Shelf Life 4 years No activation required Ordering Information Product Response Temperatures Pack Size LIMITmarker - (A) 9 C : ±1 C 100 Indicators per roll Transtracker F - (A) 9 C : ±1 C 100 Cards per box LIMITmarker - (M) 25 C : ±1 C 100 Indicators per roll Transtracker F - (M) 25 C : ±1 C 100 Cards per box LIMITmarker - (Y) 31 C : ±1 C 100 Indicators per roll Transtracker F - (Y) 31 C : ±1 C 100 Cards per box 4

6 World Leaders in Time Temperature Indicators FREEZEmarker Freeze event monitor from manufacture to patient Protecting Patients Reducing Risk Ok Ok Frozen Active Center What is FREEZEmarker? FREEZEmarker single-use indicators irreversibly changes from green to white to signal that a freeze event has occurred. A FREEZEmarker can be affixed to an individual unit to monitor the product from manufacture till use, or later in the cold chain to monitor the product for a portion of its distribution. FREEZEmarker indicators are available with response temperatures of 0 C, -1 C and -6 C. There are many cold chain medical products which are freeze sensitive. These products can be damaged and lose effectiveness if they are frozen. This is particularly true of products that require refrigerated storage. If there is a freeze event followed by a thaw, the damage to the product may go unnoticed. Dropping of cold store temperature below freezing temperature and use of frozen coolants during transportation of the product increases risk of freezing of the product. Hence leading medical product manufacturers and distributors use the FREEZEmarker to identify and prevent the administration of freeze damaged products. FREEZEmarker self adhesive indicators TransTracker C with FREEZEmarker indicator Ordering Information 5 Specifications & Performance Response Temperature 0 C, -1 C, -6 C ( ±2 C ) ±1 C Response Time Within 30 minutes Storage Temperature Refrigerated Storage ( 2 C to 8 C ) Shelf Life 1 to 4 years determined by category No activation required Temperature Monitoring Continual Device Size 20mm x 29mm Additional Features Adhesive backing Product Response Temperatures Pack Size FREEZmarker - (L) 0 C : ±1 C 100 Indicators per roll Transtracker C - (L) 0 C : ±1 C 100 Cards per box LIMITmarker - (B) -1 C : ±1 C 100 Indicators per roll Transtracker C - (B) -1 C : ±1 C 100 Cards per box FREEZmarker - (C) -6 C : ±2 C 100 Indicators per roll Ttanstracker - (C) -6 C : ±2 C 100 Cards per box

7 Protecting Patients Reducing Risk World Leaders in Time Temperature Indicators HemoTracker Time delayed Heat Excursion Threshold Indicator for blood banks What is Hemotracker? Hemotracker is specially designed device for blood unit monitoring using LIMITmarker L threshold indicator. The self adhesive single use devices is used on blood bags. The indicator irreversibly changes color from white to red to signal if a temperature defined for blood unit has been exceeded from issuance of the blood unit by blood bank till transfusion to the patient. Blood is collected at body temperature, i.e. +37 C. But in order to maintain its vital properties, it is stored at refrigeration temperatures at 2 C to 6 C and transported below +10 C. As per guidelines on Blood cold chain, temperature of blood or components should not exceed 10 C during transportation. However, in day to-day operations, transfusion services typically manage this function according to the 30 minute rule, i.e., refrigerated blood components may be held at ambient temperature for no longer than 30 minutes. Hemotracker application - A Roll of 100 nos. of LIMIarker Indicator and Roll of 100 nos. of self adhesive Hemotracker reference labels are supplied together. Stick the Hemotracker reference Label on the Blood bag and then apply the LIMITmarker Indicator at specified position on reference label before issuing the blood unit for transportation to the patient. Ok Window showing colour change Over heated Key benefits of Hemotracker Irreversible color change of Indicator is easy to read and interpret Validated, accurate and reliable performance. Assures quality of blood unit during the transportation and short term storage related to temperature. Ordering Information Specifications & Performance Response Temperature 9 C, 25 C Storage Temperature Shelf Life Product Response Temperatures Pack Size Hemotracker 9 C : ±1 C Set of 100 Hemotrackers Hemotracker 25 C : ±1 C Set of 100 Hemotrackers ±1 C Frozen -6 C 4 years No activation required 6

8 World Leaders in Time Temperature Indicators Safe-T-Vue Nonreversible Temperature Indicators for Blood products & Biologicals NEW Protecting Patients Reducing Risk White lid ring Active Square Center What is Safe-T-Vue? Safe-T-Vue is convenient, fast and easy-to-use device that can be directly applied to the blood bag or product to provide direct contact temperature monitoring. Safe-T-Vue changes color from white to red when the blood (or other temperature sensitive products), has reached or exceeded threshold temperature. As long as the indicator remains white, product may be safely reissued. Because it is nonreversible, Safe-T-Vue will indicate that an unsafe temperature condition existed, even if the temperature returns to a safe level. It is simple, reliable and cost-effective way to assure that blood components and sensitive products are maintained at safe temperatures. It is ideally suited for use by blood banks and transfusion services to maintain quality control in transport and storage of blood, and other temperature-sensitive products. To apply : Peel off the white "REMOVE" label to expose adhesive. Attach directly to blood bag. Return blood bag to refrigerator with Safe-T-Vue attached. To activate : Retrieve blood bag from refrigerator. Hold Safe-T-Vue against blood bag with finger tips and peel off the foil lid to expose red and white rounds. Fold the white round into red. Specifications & Performance Response Temperature 6 C, 8 C, 10 C Response Time Ordering Information- Please contact Lisaline team for selection of the appropriate Safe-T-Vue indicator ±1 C Immediate Storage Temperature Ambient 25 C Shelf Life Temperature Monitoring 3 years by peel off the foil lid to expose red & white rounds Continual 7 info@lisalineasia.com service.support@lisalineasia.com