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LIBERO ITS – The World’s First Wireless Electronic Time and Temperature Indicator

The easiest, most affordable indicator for continuous temperature monitoring and calculating stability budgets of pharmaceutical products or clinical studies along the entire supply chain.

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LIBERO ITS – The World’s First Wireless Electronic Time and Temperature Indicator

The easiest, most affordable indicator for continuous temperature monitoring and calculating stability budgets of pharmaceutical products or clinical studies along the entire supply chain.

End-to-end time and temperature monitoring

LIBERO ITS is an innovative electronic multi-level indicator with disruptive read-out technology. It is a device for continuous temperature monitoring and calculating remaining stability budget of valuable products along the entire supply chain. It is thin and small enough to go on any sales unit or even individual product. It is durable enough to stay on the product during the entire shelf life for up to 4 years. LIBERO ITS manages deviations for up to 6 alarm levels. The alarm status is always visible by showing Green = OK or Red = ALARM. Watch the video to see how LIBERO ITS solves the challenges of long, fragmented supply chains. 

No more guessing about product loss –
you have the proof!

If the specific stability budget of the product has been used, LIBERO ITS will show a red LED: ALARM! In most cases, the product must be discarded. But assume the product is out of your direct control. How can the product owner be informed? How can the status be documented? Moreover, how can this documentation be archived in a safe and compliant way?

LIBERO ITS offers a Smartphone App that downloads the summary statistics including time stamps, highest/lowest temperatures and excursion hour per temperature zone. Use the App to add information, inform the product owner via email and safely archive the findings. Besides supporting you in the failure analysis (who’s fault was it?) the database will also help you run a compliant and efficient cold chain.

Compliant and Certified

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WHO PQS E006

Approved by WHO for Performance, Quality and Safety

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NIST-Traceable Calibration Certificate

Proof that LIBERO ITS meets the highest international quality standards

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GAMP5 Compliant

Validated technology for regulatory compliance and your peace of mind

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IATA compliant

No battery declaration or paperwork needed

How to use LIBERO ITS

LIBERO ITS has a simple process to operate. After the electronic indicator is applied at point of packaging, it travels safely attached to the unit-level product through as many depots, handlers and modes of transport as the product faces. At any one of those transit or storage points, the indicator can be read out to give the product status (alarm/no alarm). Finally, download statistics to Smartphone or to the LIBERO Cloud.

1. Break Tab to start

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Break the tab and attach LIBERO ITS to
product with self-adhesive back.

2. Read out data wirelessly

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Monitor during 4 years and check LED: 
Green = OK, Red = ALARM

 3. Upload PDF report to database

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In case of ALARM, download
statistics to Smartphone

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Which LIBERO ITS suits your application?

LIBERO ITS is a configurable device which comes pre-configured for your convenience. We offer various standard configurations in boxes of 10 or 400.
From 3200 pieces and higher, we also offer custom, specific configurations with your temperature limits (up to 6 limits) and allowed excursion times.

COOL

Clinical Trials

Online Pharmacies

Direct-to-Patient

 

 

  • +2 °C to +8 °C (strict profile)
  • 12 Months Shelf-Life
  • Up to 5 Years Battery Life
  • 100% (NIST-Traceable) calibrated
  • Available as Box of 10 or Box of 400
  • No Stability Budget
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ROOM

Art pieces

TATS materials

High-value food

End-to-End Pharma

 

  • +15 °C to +25 °C (strict profile)
  • 12 Months Shelf-Life
  • Up to 5 Years Battery Life
  • 100% (NIST-Traceable) calibrated
  • Available as Box of 10 or Box of 400
  • No Stability Budget
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NO-FREEZE

Online Pharmacies

High-value food

 

 

 

  • Higher than 0 °C
  • 12 Months Shelf-Life
  • Up to 5 Years Battery Life
  • 100% (NIST-Traceable) calibrated
  • Available as Box of 10 or Box of 400
  • No Stability Budget
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WHO TYPE 1

Vaccines Type 1

 

  • -0.5 °C to +30 °C
  • 12 Months Shelf-Life
  • Up to 4 Years Battery Life
  • 100% (NIST-Traceable) calibrated
  • Available as Box of 10 or Box of 400
  • Stability Budget
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WHO TYPE 2

Vaccines Type 2

 

  • Up to +10 °C
  • 12 Months Shelf-Life
  • Up to 4 Years Battery Life
  • 100% (NIST-Traceable) calibrated
  • Available as Box of 10 or Box of 400
  • Stability Budget
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CUSTOMIZED PROFILES

Customizable for Any Application

 

  • Create Your Own Profile
  • 12 Months Shelf-Life
  • Up to 4 Years Battery Life
  • 100% (NIST-Traceable) calibrated
  • Starting at 3200 pieces
  • Up to 6 Stability Budget Alarm Levels
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What our Customers say about LIBERO ITS

Personalization of medicines leads to individualized product items and even individualized distribution. Therefore, temperature monitoring on batch level doesn't fulfill the requirements anymore. For these cases, temperature monitoring needs to be performed on single item level. LIBERO ITS with its size, costs and features offers all what is needed.

Multi-National Biopharmaceutical Company
Global Supply Chain Director

As trial sponsors meet patient needs for at-home clinical trials, we are faced with navigating Direct to Patient distribution challenges. Using LIBERO ITS assures us that the product is temperature monitored until the patient takes the drug and keeps the clinical trials intact.

Clinical Research Company
Clinical Trial Manager
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LIBERO ITS is beating competition in all dimensions

A Time Temperature Indicator (TTI) is a smart label attached directly to the product showing the accumulated time-temperature history of a product over its life cycle. The first versions of Time and Temperature Indicators were Chemical indicators, mainly used in the food industry. These chemical indicators worked in such a way that the physical changes of the indicator coincided with the degradation rate of the food. Therefore, the indicator could help indicate probable food degradation. 

LIBERO ITS can functionally cover and replace any other chemical indicator, freeze indicator or multi-level indicator. In larger quantities, LIBERO ITS is cost competitive with expensive chemical indicators and cheaper than any other electronic multi-level indicators or freeze indicator. 

Normal Electronic Indicator

Larger, limited statistics electronic read-out device. 

  • GAMP5 compliant & traceable with ID number
  • Attached directly to kit with self-adhesive back
  • No infrastructure, no training
  • Show status visually (OK to use?)
  • Safe and easy start
  • Accurate temperature sensor
  • Low cost for kit level (<5 $)
  • Thin (< 3mm) & small for kit level
  • Keep track of remaining stability budget
  • Life-time of a typical kit (up to 4 years)
  • NIST-traceable calibration certificate
  • Document and archive the status
  • Keep track of statistics
  • Keep entire measurement row for further analysis

LIBERO ITS

'Smart' electronic indicator with built-in stability budget and full statistics read-out.

  • GAMP5 compliant & traceable with ID number
  • Attached directly to kit with self-adhesive back
  • No infrastructure, no training
  • Show status visually (OK to use?)
  • Safe and easy start
  • Accurate temperature sensor
  • Low cost for kit level (<5 $)
  • Thin (< 3mm) & small for kit level
  • Keep track of remaining stability budget
  • Life-time of a typical kit (up to 4 years)
  • NIST-traceable calibration certificate
  • Document and archive the status
  • Keep track of statistics
  • Keep entire measurement row for further analysis
Buy Now

Chemical Indicator

Simple visual indication of temperature. Not electronic. 

  • GAMP5 compliant & traceable with ID number
  • Attached directly to kit with self-adhesive back
  • No infrastructure, no training
  • Show status visually (OK to use?)
  • Safe and easy start
  • Accurate temperature sensor
  • Low cost for kit level (<5 $)
  • Thin (< 3mm) & small for kit level
  • Keep track of remaining stability budget
  • Life-time of a typical kit (up to 4 years)
  • NIST-traceable calibration certificate
  • Document and archive the status
  • Keep track of statistics
  • Keep entire measurement row for further analysis

Request a FREE LIBERO ITS Sample Today!

Click below to get your working sample of the world's only smart, electronic, temperature (TTI) data monitoring indicator for pharma supply chain and direct to patient clinical trials.

  • Choose from a variety of popular standard configurations
  • Unique stability budget read-out via Smartphone App
  • 4-year battery life
  • Fully compliant and NIST traceable

 

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Get FREE Sample

LIBERO ITS:
Proven useful for so many Applications 

Clinical Supply Chain

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The clinical supply chain of investigational medicinal products (IMPs) is long and complex. The time from packaging a kit through to reaching the patient can take several months. In addition to the trial sponsor, there are many stakeholders involved including Contract Manufacturers, Distribution Centres, Logistics Service Providers and Clinical Sites. The clinical supply chain frequently includes different countries, several transportation legs and many days and months with product sitting on a shelf in different storage locations. Thus, if a temperature sensitive IMP is not handled correctly (through all this), the patient’s health could be at risk. In addition, the study could face challenges and lose patients as a result of non-availability of kits and/or temperature deviations. A completely managed temperature controlled clinical supply chain of IMP's is therefore a strategic, vital asset.

To sum things up:

Managing the temperature data along this complex supply chain is difficult. LIBERO ITS solves all these problems because:

  • You know immediately all excursions the shipment incurred
  • It can be attached at point of packaging and monitor product until it reaches the patient
  • It can be integrated into any IRT/IxRS system

Vaccines for developing countries

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UNICEF, WHO and many independent NGO’s are coordinating the vaccination programs in developing countries and war regions around the world. When it comes to protecting patient safety there is a whole series of additional challenges in cold chain monitoring. This is why WHO has defined the category of PQS pre-qualified electronic temperature indicators defining reliable and intuitive low cost devices covering the lifecycle of vaccines.

To sum things up:

LIBERO ITS is the perfect device to monitor WHO vaccine shipments because it:

  • Is reliable and intuitive to use − pre-qualified WHO/PQS/E006/TR07.3 Type 1
  • Comes at a lower cost than any other electronic indicator
  • Can download the statistics via Smartphone app

Direct-to-Patient shipments

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Patients in clinical trials prefer to receive IMP’s at home. An increasing trend of Direct-to-Patient (DTP) intensifies the challenge of managing the complete supply chain of pharmaceutical products. But how to document the hand-over at the patient’s doorstep? How can temperature of the valuable and sensitive product be monitored in the patient’s home refrigerator? And when they finally use the IMP - how can they decide at the point of administration, if it is still safe to use? In case of alarm, how can the study owner be informed and the status be documented?

To sum things up:

LIBERO ITS is the perfect device for Direct-to-Patient shipments since it is safe, simple, durable and intuitive to use.

End-to-end monitoring on box level

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With up to six logistics steps (e.g. filling, hub, importer, wholesale, pharmacy / hospital, patient), the supply chain of commercial medicinal products reaches maximum complexity and numerous challenges. The time from filling and packaging through to reaching the patient can take several months and involve many stakeholders, different countries, several transporatation legs and many days with product sitting on a shelf in different storage locations. Managing the temperature data along this complex supply chain is difficult. Where has the product been and what deviations has it seen? How can the status be documented when the product is sold (e.g. to a wholesaler or pharmacist)? A completely managed temperature controlled pharma supply chain is therefore a strategic, vital asset. 

To sum things up:

Stop the puzzle-and-piece of deviation hours along the supply chain. Apply LIBERO ITS directly on each sales unit or even on product item level during filling and packaging. We work with various packaging partners – for example with Dividella an innovative packaging specialist for mono material packaging solutions.

Online Pharmacies

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Internet pharmacies, influx of personalized medicines and direct to patient deliveries all require new approaches in logistics and temperature monitoring for pharmacies. The monitoring that’s used for products going into patient’s homes must be simple and easy to use. Ideally the monitoring stays on the product until the drug is used from the patient’s refrigerator.  In addition, covering the last mile must be a cost efficient solution. Temperature monitoring cannot add more than $5 dollarsper delivery.

To sum things up:

LIBERO ITS is the perfect device for the last mile and online pharmacies since it is intuitive, failsafe and cost efficient.

Medical devices

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Medical devices and many  of their components, often contain temperature sensitive materials. Examples include coated joints, drillable injects or coated stents). However, compared to pharmaceutical products, some medical devices (such as joints) have a much longer shelf life. Yet still they are temperature sensitive! Some have long shelf lives of up to five years, but it’s critical to know the product is okay to use and the temperature has always been in control.

To sum things up:

LIBERO ITS is the perfect device to monitor medical devices along their supply chain, because:

  • Battery life up to four years can monitor the entire supply chain including long-term storage at hospitals
  • Capability to carry enough stability budget and reliably monitor all excursions
  • Small, thin and cheap enough to be attached directly to each medical device

Sample Collection

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Human Biological Samples (HBS) are a key component of any drug development program. They enable researchers to investigate how drugs interact with humans prior to entering clinical trials. They also enable researchers to obtain a better understanding of the mechanism of disease to continue to develop treatments that are more efficacious. Organs, human tissue, and genetic material (all temperature sensitive) are being used more frequently in pharmaceutical research during clinical trials, but also for diagnostic purposes of genetically engineered personalized drugs. There are various challenges connected to the sample collection:

  • Small volumes (cost is an issue!)
  • Time and temperature are critical elements
  • Usually packaging (and data logger) is provided pre-configured to clinic: handling/starting the device must be intuitive, simple and safe

To sum things up:

LIBERO ITS is the perfect device for Human Biological Sample collection because it is pre-configured, device start is simple and failsafe, and monitoring data can be analysed.

API and Intra-Logistics

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The manufacturing of pharmaceutical products and medicinal products is not usually performed at one single location. Even if production takes place within one campus, temperature sensitive products can be exposed to temperatures outside the ideal storage conditions when moved from one production step to another. Regardless of whether you want to transport API drums from production to filling, move semi-finished products inside your facility or have an intra-logistics situation of finished products, you will need a monitoring solution that is reliable, small and low cost.

To sum things up:

LIBERO ITS is the perfect device for API and Intra-Logistics:

  • It monitors temperatures outside label condition and deducts times from an allowed stability
  • It is small, thin and inexpensive to apply on each drum, bag, box, or device.

Blood Cold Chain

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The blood cold chain is a system for storing and transporting blood and blood products within the correct temperature range and conditions, from the point of collection − from blood donors − to the point of transfusion to the patient. Deviations from the defined temperature ranges during storage and transportation of blood and blood products can affect the quality, thus leading to reduced benefits. It can also increase the risk of bacterial infections and may cause potentially life-threatening transfusion reactions. The World Health Organisation (WHO) therefore suggests using Blood Time Temperature Indicators (BTTI) on blood shipments.

To sum things up:

LIBERO ITS is more reliable than any other Blood Time Temperature Indicator (BTTI) on the market:

  • It is more reliable and more accurate than any other chemical indicator on the market
  • It is small and thin enough to monitor blood products
  • Specific configurations can be designed for the specific fractions: Fresh blood & Red Cells (+4 °C), Pooled pellets (+22 °C), Frozen plasma (-25 °C)

Seafood TTIs

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To avoid foodborne illness, temperature of seafood products must be monitored during storage and transportation along the entire supply chain. In the Fish and Fishery Products Hazards and Controls Guidance, the U.S. Food and Drug Administration (FDA) assists processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. One important requirement in the guideline is the application of Time and Temperature Indicators (TTI) on seafood products. Those chemical temperature indicators are sensitive to temperature and must be shipped temperature controlled.

To sum things up:

LIBERO ITS is the perfect tool to monitor the shipping and storing Seafood TTIs because it is reliable and easy to use; and can cover transportation and storage at the customer site until a TTI is applied.

High Value Food

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Today the cold chain of food products is typically very well organized from the farm to the wholesaler. Warehouses, processing plants, containers and trucks are cooled and monitored along the supply chain. However, the challenges are increasing with online business and in particular the last mile: how can high value foods such as flowers, wines, chocolate or caviar be protected until consumed?

To sum things up:

LIBERO ITS is perfect for monitoring device for high value food items since it is thin and small enough to go on every box. It is simple and intuitive to use.

Time and Temperature Sensitive Materials

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Some industrial materials are sensitive to temperature and therefore classified as TATS (Time and Temperature Sensitive Materials). The main TATS is carbon fiber prepreg – initially only used in the aerospace industry. Other examples of temperature sensitive materials are fiberglass, Kevlar, sealants, color and potting materials, today used in various industries such as aerospace, automotive, sporting goods, and wind energy. 

TATS require proper storage, transportation and handling to ensure quality and integrity. They are often stored several months and years before being used.

To sum things up:

LIBERO ITS is the perfect electronic indicator monitoring transport and storage of the TATS until they are used. LIBERO ITS can be attached directly to the roll and monitor temperature for up to five years.

Art on Loan

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Art pieces are sensitive to humidity. Since relative humidity is changing with temperature, the most important parameter to control and monitor during storage, transport and exhibition is temperature. Attached to the backside of a painting, LIBERO ITS can check temperature every minute and record every deviation from the defined temperature limits. The ideal storage condition of art is +15 °C to
+25 °C at a relative humidity of 40% RH to 60% RH. If temperature drops from +20 °C to +19 °C, relative humidity can increase to 54% RH. How can you be sure that your art piece on loan has always been treated as promised?

To sum things up:

Apply LIBERO ITS to each art piece on loan for complete reassurance.

  • At any given time, you can check if the art piece has ever been outside +15 °C to +25 °C by pressing the button and checking if the LED is green or red
  • Download the statistics to your Smartphone to determine the highest and lowest temperature ever measured and get the exact number of hours the art piece may have been exposed to wrong temperatures
  • Monitor uninterrupted for up to five years with LIBERO ITS battery life

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