Aggregation Complexity vs Serial Reconciliation
Updated: Aug 6, 2019
One thing I often hear is that Aggregation is too complicated to install or that it makes the production process too inefficient. My instant reaction, quite honestly is "Rubbish!!" - being English helps sometimes. :-)
In my previous role together with my excellent team and partners (one of whom I now work for) I oversaw and physically installed many or the 80 or so serialization solutions employed. 100% of these contained full aggregation, unit to pallet.
The challenge of not aggregating is relatively simple to portray. You print a carton, it gets inspected, if it fails, it is rejected and the majority that pass get packed into the next stage of production. Or do they? The problem is that most companies who do not aggregate also have no idea as to whether a unit level item has been packed at any stage of the process. At best, they can hope that the total of full pallets plus the full cases on the final pallet and the partial case is close to the number of 'passed' serials - in general it isn't for a whole range of reasons. On occasions, I've heard of failed units being packed in error and that the total number of units sent to the warehouse of 1-8% different (up or down) to the verified quantity.
In a world where the industry is trying to ensure that only real product gets handed to the patient, this situation is really unhelpful and actually dangerous.
Often, I hear that the reason why a company hasn't aggregated their lines is that "the regulations don't require it". Whilst, in many countries, this is true, what pharma is failing to recognize is that by saving money today (approx 20% of a line cost is in the aggregation to case and a further 5-10% to get to the pallet) - they are committing themselves to a world where no-one really know that the passed or failed product has actually been packed or not - this is good for no-one. Further, by deferring the install to later, the cost will grow to 40%+, not to mention the whole extra set of validation and second change controls that will be needed.
For cartons, aggregation is, depending of the choice of provider, simple and relatively quick. Numerous methods exist from reading serials in a case on a table using a top camera to integration into an automatic case packer. With a number of basic steps in place, these processes not only give the assurance that the failed pack isn't in a case somewhere, but also are extremely efficient. The basics involve good sized ECC200 codes on the packs, nicely spaced characters for the human readable and the use of a god quality print & apply for the case label. The palletizing is really easy and 100% accurate.
In the case of the bottle, it is usually necessary to apply a 'helper code' to the top of bottom of the bottle, pass through a 360 station (which links the helper code to the serial) and then use this to enable a picture in case of a layer of helper codes to perform the aggregation. In this case, the helper code needs to be as large as is practical - UV ink can be used to reduce the impact of the end patient.
The net result is, that in most software, it is now possible to achieve 100% serial reconciliation within minutes of a batch ending. Contrast this to the 'search' for why the quantity doesn't match in the unit serialization only world. Not only is the process more secure, but you stop sending items into government or 3rd party systems that shouldn't be present.
The other aspect of aggregation, which again, has not been well considered is that by creating the accurate relationship between unit and pallet (via optional Bundle and Case) - it is now possible to ship pallets of product to different locations and only send the receiver the serials relating to what they have received in terms of physical stock. Without this, if a batch is split into two destinations, each location has to receive 100% of the data - which means there is 100% redundant data in the supply chain. 200% for 3 and so on.
Another excellent case for aggregation is the ability for the 3PL to be able to pick and ship by case and thus be able to send just the actual serial numbers to the next step in the chain. Again, without this, one of three things occurs:
- All data has to be sent to the case recipient (creates huge waste)
- No data is sent (not really legal)
- 3PL has to scan each pack before sending it (expect a bill from them)
No of these are great for modern industry. IN a world where we are talking about connected devices and Industry 4.0, not aggregating, just doesn't make sense.
Xyntek has both the relationships (through AntaresVision) and the internal expertise to make your Aggregation journey as simple as it can be. Indeed, the Antares suite can be used at the end of any packing line for Aggregation, irrespective of the chosen unit serialization solution. Data is either integrated or learnt live and the result is a properly aggregated Unit/Bundle/Case/Pallet (as needed). Give us a call if you are suffering or undecided - the business case is there and it's not as expensive as you might think.
Ian Parsonage
Senior Director, Global Management & IS Consulting