In a prior blog post I discussed how serialization in the world of prescription drugs provides end-to-end product integrity as it tracks and authenticates each change of ownership of the product through the supply chain. With serialization, pharmaceutical companies can dramatically reduce their economic, regulatory and reputational risks, minimize the probability of product mix-up during the distribution process, and combat the spread of counterfeit drugs.
Now that we have covered the merits of serialization, this blog post will map out a well thought-out implementation. How do you determine which solution best meets your requirements? There are five important questions to ask as you embark on your serialization journey.
1. Is the serialization solution able to meet all needed country current regulations and expected future mandates?
Today, the majority of the world is adopting GS1 Standards. Given the popularity of GS1, it’s critical to select a GS1 compliant solution. In addition, it is logical to assume that at some point in the future, a global serialization standard will be set so countries can exchange information freely. The most likely choice for global serialization is GS1, which makes GS1 compliance even more important. Finally, regulations may evolve over time, so it’s vital that the solution allows for capturing of additional user-defined data fields for future mandates.
2. Is the serialization solution compatible with existing systems?
One of the biggest challenges pharmaceutical companies face is implementing a serialization solution that can be easily synchronized with existing operations management solutions. Solutions that can easily interface with systems such as Enterprise Resource Planning (ERP), quality management systems and Manufacturing Execution Systems (MES) are typically requirements for integration. Advanced software solutions can also reduce the burden on existing systems by generating and managing their own serial numbers (when allowed by local regulations) and communicating that information back to the Electronic Product Code Information System (EPCIS) repository when they are commissioned.
3. Is the serialization solution hardware agnostic?
A serialization system needs to be compatible with all the hardware necessary to support labeling such as vision check cameras, high speed printers and thermal label printers. Consider a solution that is compatible with most of the major hardware vendors – for example, Cognex for vision check cameras, Markem Imaje, Domino, Videojet, HSAJet and Weber for high speed printers, and Zebra, SATO, Avery Dennison, Datamax and ARM Propix controllers for thermal label printers. In addition, it’s critical to consider integration with your current packaging line equipment – select a hardware agnostic solution that allows you to build on top of your existing equipment and devices instead of conducting an expensive rip-and-replace.
4. How many levels of aggregation can the solution handle?
Let’s now take a look at unit-level serial numbers at the packaging line. In the example I have below, consider this scenario:
- 1 unique serial number gets printed onto every mono carton
- 8 mono cartons are packed into an outer box and 1 unique serial number gets printed onto every outer box
- 12 outer boxes are packed into a shipper box and 1 unique serial number gets printed onto every shipper box
- 50 shipper boxes form a pallet and 1 unique serial number gets printed onto every pallet
In this scenario, it is necessary to handle 4 levels of aggregation. When selecting a serialization solution, take into account how many levels of aggregation it can take on.
5. Will the higher aggregation know if a box is rejected at the previous aggregation?
In order for the aggregation information to be accurate, the serialization solution needs to be able to detect a rejected box at its previous level. The various serialization aggregations in a packaging line shares one database, hence the parent level will be made aware of the rejection of any child level. In the same example above, if a rejected mono carton is mistakenly packed into an outer box (usually due to human mishandling or system shortfall), a good serialization solution will detect the error and reject the entire outer box which contains this rejected mono carton at the outer box station.
This is especially critical in pharmaceutical manufacturing – in other industries where the contents of a package do not match the shipping document, the package can be returned. However, in the world of prescription drugs and biologic products, aggregation inaccuracy can result in costly regulatory violations.
Join our webinar to learn more about the benefits of Serialization.
A serialization solution to meet your needs
With the multitude of solutions available, it’s important to select the right one. By asking these 5 questions, it’s possible to choose a serialization solution that best meets your needs. To learn more, join our webinar on Adopting Serialization in Pharmaceutical Manufacturing.
Do you have any additional questions on serialization? Ask us in the comments below.