This document defines the serialization management OPC UA interfaces to support global regulation reporting requirements and the packaging serialization management process from the enterprise serialization manager to the packaging lines for serialized products.
Healthcare supply chain systems are being deployed to meet the product serialization and track-and-trace country regulations and laws to address the widespread healthcare counterfeiting issues. The regulations and laws require healthcare manufacturers to apply unique serialized identifiers to individual instances of physical objects for supply chain serialization and track-and-trace purposes.
Unique serialized identifiers may be generated within a company, may be obtained from regulatory authorities, or may be obtained by contract manufacturers from product owning company, depending on the regulations or laws that apply to the product and the intended market.
- A Serial Number is a string of characters with a defined syntax used for purposes of establishing uniqueness between otherwise identical objects.
- A Serial Number Collection is a collection of Serial Numbers which have not yet been printed onto a label. Serial Number Collections are defined to provide for efficient exchange of collections of Serial Numbers.
- A Label Collection is a collection of Serial Numbers with the same state and associated information needed for the label such as lot numbers, expiration dates and manufactured dates. Label Collections are defined to provide for efficient exchange of collections of Serial Numbers with the associated other information needed for the label.
- A Serialized Identifier is a unique identifier (serial number) comprising of a string of characters within a defined format that is associated with a physical object such that no two physical objects are associated with the same string of characters. Abbreviated as SID. An example of an SID is an Electronic Product Code (EPC) that is a unique identifier attached to a class of product or aggregation such a pallet, with the addition of a unique serial number for each product or aggregation.
The general lifecycle of a Serial Number is from unassigned, to associated with a production run, to representation on printed label, to a commissioned label, as shown in Figure 1. When the serial number is printed it is combined with other information required on the label, for example: product code, lot number, expiration date, etc. Figure 1 illustrates the stages of Serial Numbers:
- An unassigned Serial Number, where the number has not been assigned to any specific product, production order, or packaging run.
- A provisioned Serial Number containing the serial number in a digital form that has been associated to a specific product, package type, production order, or packaging run.
- The Serial Number as it is printed on a label and combined with other label information, but not yet applied to the physical product, called a printed label.
- The printed label as it is applied to the physical product, called a commissioned label, and identified as a Serialized Identifier (SID).
In some cases, the activity of serialization includes the packing of serialized child objects (packages) into serialized and parent objects (containers) in a process identified as aggregation. Serialization aggregation events usually start with the Lowest Saleable Unit (LSU) (e.g. bottle or blister pack) and potentially include multiple levels in the packaging hierarchy (such as a pallet made up of cases, cases made up of packages, and packages made up of blister packs, with serialization information defined at each level of the hierarchy.) Aggregation Serial Numbers follow the same lifecycle as product Serial Numbers.