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Direct-to-Patient and
End-to-End Monitoring

Monitoring throughout the supply chain

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Direct-to-Patient and
End-to-End Monitoring

Monitoring throughout the supply chain

From Labeling to Last Mile:
Kit-Level Monitoring Throughout the Entire Cold Chain

 

With an increase in direct to patient (DtP) deliveries, the scope of GMP and GCP has somewhat shifted to temperature monitoring capabilities by large couriers and the patient. So, anything that gives the patient a clear “ok” or “not ok” supports compliance and helps ensure patient safety.

Sophisticated automation, such as Dividella’s cartoners NeoTOP and NeoTRAY, enables smart electronic indicators to be applied and started on box-level, so that stability budget can be measured and monitoring from end-to end throughout the entire supply chain. Watch the video below to see this how this automation works.

Let's talk about your next end-to-end project...

 

1. Schedule Project

Start-up /Scoping Call

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2. Receive Proposal of

Services & Costs

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3. Schedule Date &

Resources Required

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Schedule a Call

Electronic “Smart” Indicators vs. Chemical Indicators

 

Monitoring temperatures at kit-level during clinical trials is not a new concept. Chemical indicators applied at box level have existed for decades. However, they are typically not precise enough for IMPs and are difficult to validate, therefore they not considered GxP-compliant.

Electronic "Smart" kit-level indicators offer distinct benefits over chemical indicators. Consider the following checklist when evaluating various electronic Indicators. Ideally, your choice should include the following criteria: 

  • Developed and produced according to GAMP5 guidelines and equipped with a unique ID-number to allow traceability

  • Low cost. (e.g. Can tens of thousands of kits be equipped for less than $5 USD per piece?

  • Must be thin (<3 mm) and small enough for use at the kit level (e.g. less than the size of a credit card

  • Easily attached and activated directly to kit with self-adhesive back; or by the thousands on an automated packaging line

  • Enough battery capacity to cover the entire life-time of a typical kit (up to 4 years)

  • Calibrated and accurate temperature sensor (with NIST-traceable calibration certificates

  • Continuously monitor temperature and keep track of remaining stability budge

  • Easy to read status (OK to use?) at any time without additional equipment; intuitive and easy for healthcare professionals and patients to us

  • Documents and archives the status in compliant way (no manipulation possible); allows for easy feedback to sponsor in case the stability budget is used-up (ALARM)

  • Track statistics (e.g. time per temperature zone, highest and lowest value) as well as date/time of alarm for further analysis by the sponsor

  • WHO Pre-qualified status

The Smart Indicator That Fits Every 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 customer-specific configuration 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
Buy Now

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
Buy Now

LIBERO ITS Indicator for Pharma Supply Chain

 

Small, durable and extremely cost-effective. Smart electronic indicators provide end-to-end quality assurance needed in the Last Mile.

We make Patient-Centric Clinical Trials easier.

 

Book a 15-minute meeting with one of our experts, in which we can discuss: 

  • Temperature Monitoring game plan for your patient centric trials 

  • Deviation SOP 

  • Stakeholder Management

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ELPRO LIBERO ITS end-to-end monitoring solution

New

Whitepaper on Temperature Monitoring for Direct-to-Patient Logistics

A New Approach for Temperature Monitoring in a Changing Clinical Supply Chain Environment

DOWNLOAD

Questions? Contact us today.