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.
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
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.
we prove it.
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