Pharmaceuticals : Simplifying FDA Regulatory Compliance Through Automation

THE SITUATION

Pharmaceutical and bio-medical companies have extra scrutiny placed on them when it comes to following FDA regulations. To follow these regulations, this particular pharmaceutical processing and distribution company also falls into what the supply chain industry calls “Cold Chain” distribution. This means that all orders are either single container or multi-container, with each container made from a corrugated carton lined with Styrofoam or a Styrofoam only container, with most containers requiring dry ice (frozen CO2). Due to the dry ice, these containers require special labeling and a packing slip along with other instructions on the outside of the container. Many of the pharmaceutical products this company distributes are considered narcotics, so some of the shipping containers—in addition to the dry ice and specialized labeling requirements—have a small footprint, allowing for only a small label and instruction packet to be placed on the top.

And, in a final expensive twist, this distribution center only hires pharmaceutical university graduates to guarantee that the transactions at the packing station are 100% correct for each order.

THE PROCESS

The Integrator’s distribution center design bypassed the previously manual packing stations. The orders were now checked using barcode scanning verification, automatically closed, dry ice warning labels applied to the container sides, and PSI’s AutoSlip applies a combination packing slip, instruction set, and shipping label facing outward through the clear plastic pouch to the box top. After all these automated transactions are completed and rechecked within the database, the orders are sent to the shipping area and palletized.

THE SOLUTION

To address these very specialized concerns, the Integrator working with this distribution center approached PSI Engineering with a focus on PSI’s AutoSlip—an order fulfillment automation product designed specifically to laser print, fold, insert into a plastic pouch, and automatically apply any combination of packing slip, other document, and the shipping label facing outward.

This Integrator recognized PSI’s expertise, knowing PSI had installed other systems of this nature in the past. PSI was able to demonstrate to the customer how the Autoslip met their stringent FDA requirements of 100% accuracy of all document automation components for the outside of the containers using PSI’s 2D barcode scan and compare system.

THE RESULTS

The end user bio-pharma distributor is now shipping an increased order throughput, and achieving 100% correctly assembled orders with the automation supplied by PSI Engineering. ROI was achieved in less than 18 months with the same technology to be installed at each of their facilities worldwide.

 

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