With sections of the DSCSA (Drug Supply Chain Security Act) set to take effect in 2017, several companies have started planning ways to integrate serialisation into their existing packaging lines.
Interestingly, Apace Packaging had already started their serialisation effort, as reported by ePedigree Law of California, when the FDA first announced its DSCSA. Later, when the DSCSA pre-empted that law, Apace Packaging had a choice.
However, it decided to move forward and add a completely aggregated serialisation solution to its existing packaging lines, thus becoming one of the first packaging companies to do so.
Apace Packaging’s 7-Step Process for its Packaging Lines’ Serialisation
By integrating serialisation into its existing blister and bottle packaging lines, Apace Packaging aims to offer comprehensive solutions to its clients. The company uses three components in its process to ensure that all its serialised packages are constantly tracked throughout packaging and shipment.
For the warehouse section, Apace uses ROC IT Solutions, while its packaging line level utilises Optel Vision . it uses OPSM (Oracle Pedigree and Serialisation Manager) for producing serial numbers and storing the EPCIS events (in the Oracle OPSM repository). For its ERP system, accounting, warehouse information and billing, Apace also uses Oracle’s EBS (e-Business Suite).
Apace uses an integrated 7-step procedure to run its wholly aggregated serialisation solution that’s DSCSA-compliant. These include:
* Step 1 Batch startup, where the product master data is retrieved by Optel Vision from Oracle’s EBS in the initial step, after which it requests serial numbers from OPSM that can be applied to the batch. For the master data, EBS is used as the single source of truth (SSOT).
* Step 2 Maintaining an SSOT, especially when using multiple information systems, is particularly important to ensure consistency.
Also packaging process at this point, where serial numbers are applied to every GTIN level (bundles, bottles and cases) by Optel Vision.
* Step 3 Aggregating & commissioning serial numbers, where items are packed on the line and Optel Vision records which products are getting packed into higher-level serialised items. After the full hierarchy is captured, the OPSM repository receives the information and packaging structure is recorded to be used in the next steps (4 to 7) of downstream processing.
* Step 4 of post-batch completion rework is carried out when either rework is required or a need is there to rebuild a damaged pallet or case, or for QA sampling.
* Step 5 involves shipping/receiving serial numbers for finished goods inventory. Once the serialised product is transported to another location or received into inventory, Apace employs the ROC IT solution to process the incident, scan the pallet tags, and then send the resulting EPCIS events to OPSM and the receipt/shipment events to EBS.
* The optional step 6 involves rework of serialised containers in the Distribution Centre (DC). Possible scenarios could involve QA sampling and preparation for packing and picking orders for shipment.
* The last step involves invoicing, distribution and data transfer functions. After the completion of the shipping process, ROC IT communicates with both the OPSM and Oracle EBS so that after invoicing a product, the data transfer for the serial numbers and related aggregation data can be sent to the data management system of the customers for their use.
With the serialisation on each of its four packaging lines (2 bottle and 2 blister lines respectively), Apace Packaging has witnessed a significant growth over the past few years.
It plans to continue its expansion, with the addition of a new warehouse by this year-end, along with plans to add another high-speed bottle packaging line in the next year.
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