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Pharmaceutical
Pharmaceutical, biotech and life sciences companies use Cloudleaf to collect data in real time about time-sensitive samples and environmental conditions, increasing FDA compliance and decreasing waste.

The pharmaceutical industry loses approximately $12B in revenue each year due to penalties and material waste. With a growing risk of counterfeit drugs, inability to verify ingredient movement history or transaction handoffs––transparency and tracking in the value chain has never been in greater demand.

A Closer Look: Pharmaceutical Case Study

Challenge

Lack of insight and visibility throughout the handling process leads to biomedical material ending up in quarantine for retesting or complete material loss.

Solution

Location-enabled insight across all processes and touchpoints minimizes waste and provides the detail to meet FDA regulations efficiently.

Results

Real-time location and inventory tracking of biomedical material containers results in annual savings of $10-$15M dollars.

Customer: Biotech company that collects and transports time-sensitive biomedical material from 82 donor centers.

1. Critical Tracking Points: Arrival

Raw material bottles arrive at the facility, are unloaded and transferred to a facility pallet, which have to be moved to the freezer right away. The loading dock is not refrigerated, so it’s critical to move the pallets into the freezer as soon as they are unloaded.

2. Critical Tracking Points: Excursions

At the time of production, pallets are moved to a cold room for sorting by origin and profile. The sorted bottles are then placed on new pallets and returned to the freezer. As the bottles spend time out of the freezer, temperature excursions occur. Material must remain within the FDA excursion thresholds for time out of the freezer environment.

Summary of Tracking Needs

The company wants to track dwell time in each zone so that bio material spends the minimum amount of time in each zone, therefore preventing it from having a temperature excursion. They also want to capture complete movement history for seamless compliance with FDA regulations.

Cloudleaf Solution

Providing a complete system to accurately monitor location, dwell times, condition and history, the company has experienced a reduction in re-testing, spoilage and waste, amounting to millions of dollars saved. When the FDA does a compliance check, a complete record of movement history is always available with the click of a button, resulting in significant administrative cost savings.

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