Time is short: Serialization for the USA

Serialization becomes compulsory in the USA from November 2017

Pharmaceutical companies and contract manufacturers need to act now to obtain market access for their prescription drugs. What does this involve?

Serialization for the USA is centred on the Standardized Numeric Identifier (SNI): this element comprises a national registration number for the medicinal product concerned and a unique serial number for each pack. Each unit must also carry the lot number and expiry date as a mandatory requirement. All data must be condensed in a 2D datamatrix code and printed on the pack. The serialization data are reported to the parties involved e.g. wholesalers along the entire logistic chain via e-pedigrees so that the flow of goods can be seamlessly retraced.

Transferring large data volumes along the logistic chain

The GS1 EPCIS (Electronic Product Code Information Service) standard is available to facilitate the exchange of large data volumes between the individual logistic partners. Events in aggregation hierarchies or from goods transactions can be described and transmitted across systems by means of the XML-based interface. MEDTRACKER serialization software already has an integral EPCIS interface permitting straightforward communication with wholesalers or logistic service providers.

As of November 2023, sharing the codes of higher packaging hierarchies, will become compulsory, making aggregation advisable. A central Level 3 software solution is in turn required to reliably model the entailed steps in the packaging process, including repackaging operations in the warehouse.

The task at hand: to serialize and aggregate HDPE bottles

For serializing the HDPE bottles conventionally used in the USA for packaging tablets and capsules, it is recommended using the product identification labels. These can either be pre-printed with a serial number or coded inline. The DIGILINE Label printing system from Atlantic Zeiser in either the nearline or offline (roll-to-roll) variant is ideally suited for this purpose because of its consistent, abrasion-resistant printing quality and high speed, which is based on the OMEGA DoD UV inkjet. It also has an integrated MEDTRACKER interface. However, the biggest challenge is posed by physically aggregating HDPE bottles in a packaging line in a fully automatic process. This is reliably accomplished inside the case with the aid of helper codes. These are applied to the base or lid of the bottle and refer to the serialized data on the original bottle label which, because of its lateral position, is no longer visible at this point in the automatic packaging process. Camera systems integrated in the case packer then read the helper code rather than the original label (see figure). In this way, a packaging hierarchy can be created in the serialization database and a parent code generated for the case, ensuring process security.

Imprinting the helper code on the base or lid of the bottle and linking it to the label is executed as a separate process stage via a module that must be integrated or several individual components. Irrespective of this, the automatic case packers must be equipped in such a way that they are able to print, apply, verify and reject labels for the cases. Furthermore, scope for manual reprocessing must also be provided. MEDTRACKER software can visualize all of this easily by integrating the necessary hardware components.

Michael Urso
Michael Urso
About Michael Urso

Product Manager Pharma & Packaging Solutions | Atlantic Zeiser

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