Got it bottled
Getting your arms around the bottle – implementing serialisation for high speed integrated bottling operations, by Ian Parsonage, PCI.
Relatively cheap and logistically effective, bottles have steadily become the standard for drug delivery. Bottles come in a variety of sizes and shapes, and the economics of bottles make them attractive for delivering a month or three months’ worth of medication cost effectively. Companies tasked with packaging opt for high speed – high volume bottling lines that are predicated on efficiency. That efficiency is what makes the prospect of integrating product serialisation such a daunting task for most drug companies.
With speeds reaching multiple hundreds of bottles per minute, a typical bottling line is the integration of many parts, each providing vital services to the overall delivery and each a lynchpin for the overall line efficiency. Bottles may be packed in trays, cartons, or bundled into groups by a shrink-wrapping prior to placement into shippers prior to palletisation. Adding supplemental stations for serialisation creates reasonable concerns for companies trying to achieve every percentage point of OEE.
Evolving international requirements around serialisation and track & trace are a patchwork of varying standards. Many developed countries have aligned with GS1 standards, while other developing countries have requirements that vary. In the US and Europe legislation has pushed to 2017, whereas markets such as South Korea, China, and Turkey have more immediate requirements. This creates a burden in serving international markets. When implementing serialisation, these developing requirements add to the complexity of product changeovers, which can impact one of the key elements of achieving favorable OEE and profitability.
Serialisation requirements dictate the application of a unique identifier on the primary unit-of-sale. For bottling operations, this ushers new equipment into the line. Additional complexity is added when the individual unit-of-sale is then married up to its tray, bundle, or shipper. When applying serialised codes to individual bottles, codes are typically applied to the bottle label, readable on the body of the bottle. When bottles are accumulated for the bundling operation these individual codes are then obscured when unitised into bundles. This concern over line-of-sight creates operational challenges for in-process electronic verification. One of the principles of aggregation is the inspection step, verifying what is contained in the grouping. This data must be vetted to ensure the integrity of the aggregation process. Individual bottle codes need to be verified and then aggregated to the bundle and its own code, with electronic verification. The challenge is introduced as individual bottle codes visible on the label are obscured when bundled into larger units. This aggregation cascades through subsequent logistical operations at downstream trade partners in the supply chain.
The simple solution is to apply a redundant second barcode to the cap. This enables a vertical inspection of the bottles. The challenge, however, is negotiating the addition of this extra barcode with Marketing personnel who may view its presence as unsightly. One solution to these aesthetic objections is to apply an ultraviolet (UV) code, imperceptible to the human eye.
Commonly, a more significant obstacle to applying codes to the top of the bottle is that the majority of these plastic closures contain raised lettering for opening instructions, and this uneven area creates a substantial challenge for applying and verifying barcodes.
The first option is to address this is potentially applying codes to the insert should it be adhered to the top of the bottle. Similar to what was described above this can be achieved through an overt barcode, or more subtly, applied with UV ink.
Alternatively, in situations where the insert may not be applied to the top, manufacturers may be forced to look to applying codes on the bottom. Depending on the size, shape, and orientation of the bottle this may also introduce substantial complexities.
Aggregation of bottles-to-bundles is then mirrored as bundles are packed to shippers again with their own serialized code. These shippers are aggregated to the pallet. Each step is electronically captured and verified to ensure a structured and robust hierarchy of codes, critical to the logistical integrity of the supply chain.
In bottling, speed and efficiency is of the essence. Carefully consider proposing new equipment and new systems are installed and validated as the consequences can be substantial on overall cost. At PCI we spent over 24 months carefully reviewing technologies and service providers before settling on a global serialisation solution for our 16 sites. Our experience, and that of our clients, has been the investment in time and consideration was well spent in maintaining efficiencies and supply continuity.