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 kit-level have existed for decades. However, they are typically not precise enough for IMPs and are difficult to validate; therefore, they are 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 GAMP®5 guidelines and equipped with a unique ID-number to allow traceability

• Low cost. (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 lifetime of a typical kit (up to 4 years)

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

• Continuously monitors temperature and keeps track of remaining stability budget

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

• 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)

• Tracks 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