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

ELPRO and Dividella Cooperate in Making Pharmaceuticals Safe –

From Packing to Patient.

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