In November of 2013, the Federal government in the United States passed the Drug Supply Chain Security Act (DSCSA) to identify and trace certain prescription drugs as they are distributed in the United States. The FDA, in partnership with drug supply chain partners, will phase in development of the DSCSA-mandated drug tracking system by implementing a series of requirements over a ten- year period. It mandates a unique product identifier on certain prescription drug packages on primary and secondary pharmaceutical packaging beginning in 2017.
Global traceability initiatives, such as the DQSA, are designed to impair the replication, production and distribution of imitation or counterfeit pharmaceuticals. These initiatives can require identification and authenticity features on primary, secondary and tertiary packaging levels typically in the form of unique, non-predictive, serialized and machine readable codes.
Selecting valuable, trusted partners is a primary objective for pharmaceutical companies as they prepare for the challenges that will come with serialization. Planning required for 2017 starts now. Put your trust in the experts. Brenton has adjusted and developed business processes to successfully install numerous stand-alone machines and completely integrated systems complying with the DQSA.
Why Brenton and Currie?
Brenton and Currie have extensive experience in designing, integrating and manufacturing legislative compliant end-of-line solutions for customers in the pharmaceutical and healthcare sectors. We recognize our customers’ challenges to comply with emerging global legislation. Brenton carefully and diligently reviews specifications and incorporates technology to meet the demanding requirements of pharmaceutical companies while ensuring high overall equipment effectiveness and maximum uptime. Brenton can support customers with appropriate plans as customers obtain FDA validation.
- We can integrate ID Technology or customer specified printers and/or labelers to provide a bar code that can be easily read electronically.
- By incorporating redundancy within our controls system Brenton helps manufacturers insure the functionality of the system is sound.
- Integrated vision systems and processes verify the product identifier on prescription drug packages.
The following real life application highlights technologies for end-of-line solutions such as case packing, palletizing, material handling and robotics that are optimal for secondary packaging in cooperation with FDA key provisions that need to be implemented within ten years of the Act being signed into effect:
Real Customer Solution
The Brenton system tracks identifiers for each of the bottles in the case and communicates that information, along with the case identifier to the customer’s database. The bar code scanner scans cases prior to the second robot bottle sorting.
The operator enters a SKU. The case conveyor feeds a single case to the scale/pick station where the robot vacuum picks the case from the scale and presents the case to the label applicator and signals the applicator to apply. Once the labeler signals that the cycle is completed, the robot lifts the case to the inspection station where the integrated vision system inspects the applied label. The robot then rotates the case to present the adjacent panel for label application and again the applied label is inspected. Cases that do not pass either label inspection are placed in a reject location.
Good (sorted) cases convey to the end of the case trunk conveyor. The flaps are mechanically closed and then delivered to the taper. Taped cases are discharged from the taper and then transferred to the palletizer.
Cases are metered into the pick station. The robot picks a group of cases and passes them in front of bar code scanner. Case data is captured and tracked to the pallet being palletized. The robot continues to cycle until the pallet is complete. Completed pallets are indexed out of the palletizing cell.
Processed and completed pallet loads are indexed onto the Orion turntable stretch wrapper. The system prints and applies a License Plate Number label and shipper label to all four sides on the exterior of the stretch wrapped pallets. Case identification data for cases on the pallet are associated with this pallet License Plate Number and are communicated to the customer’s database. At the discharge of the print and apply station, a bar code reader confirms readability of the code.
At the end of the process operators have the option to print out a lot record. The data includes quantity of shippers palletized, number of completed pallets discharged, lot number run, and operator badge number who opened and closed out that lot.
We are the preferred partner for pharmaceutical and healthcare companies.
More on DQSA via http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm