Serialization for Generics: Yes We Can—An Interview with John Clark of Athlone Labs
As generic manufacturers take on increased importance in global pharma, serialization and track and trace efforts must meet their needs. John Clark, commercial director of the Irish generic drug manufacturer Athlone Laboratories, discusses the BRIDGE project and implementation at his facility.
PhM: What software platforms or IT infrastructure did you have in place to help with traceability and this project?
J.C.: None. We are a small antibiotics manufacturer. Although we supply 30 to 40 countries throughout the world, most of our production goes to the U.K. At the moment, there are no requirements for tracking products in the U.K, but this pilot did seem to be an interesting opportunity.
As a generics manufacturer, we’re in a high-volume, low-value market and it’s always tough for us to find some value proposition to sell to our customers. There’s no point just being the cheapest all the time. That never works. One is always looking for an edge.
These days, patient safety is becoming a big issue. This project seemed to offer two opportunities:
- To improve safety and traceability of product
- To give us an edge in the market, so that we can be the first to offer something that, eventually everybody else will have to.
From a commercial point, that’s what drove me. Seemed like a good opportunity.
PhM: What was required from you, your team, your company?
J.C.: We had to do a number of things. We had to allow the team of technicians from Domino, the company that coordinated the Bridge pilot, to put equipment into our production line. We said from the beginning that we would not stop production, but would have to find a way of working around it. People had to come in evenings and weekends, and work around our schedules, to implement the solutions.
For instance, we had to put a laser printer in our blister packaging line that could lase onto each pack a Data Matrix code, then we had to install reading equipment at the end of the line, to make sure that everything went through correctly. We then had to put a label on the shipping box, which said what was inside the package. At the warehouse, a final pallet label was then placed.
It was a challenge to get the reading system to work at production speeds. The coding worked very well. The laser did a great job. We had to change the artwork slightly so that we could burn code into pack.
However, reading the codes was much more difficult.
PhM: How did you solve the code readability problem?
J.C.: In the end we had to slow production speeds, which we expected. After all, this was all new, “first time” stuff, and you don’t expect everything to run perfectly at first.
We had other issues with putting the codes on bottles. We produce bottles for reconstituted product. When you place code on a round bottle, the bottle turns as it goes down the line, so it never ends up in exactly the same place. We wound up solving this problem by coding at the top of the bottle, on the cap.
PhM: By how much did you have to slow down your production lines?
J.C.: We probably wound up dropping by up to 50% on speed. This is by no means a final solution that we put in place, but a starting point.
PhM: How did operators react to the project?
J.C.: People are always skeptical initially, with any new project, but things change when they can see benefits. Being on the cutting edge is exciting, we were leading the industry in a way, so people bought into it. People gave up their weekends. They liked to get involved and they were great.
PhM: What were some solutions to maximize line speed?
J.C.: As far as printing on the cartons, the laser did the job well. We tried several different positions, but eventually the printer was built into the casing inside equipment, we installed a whole rig to hold it there . . . if we needed to get it out of the way, we could switch it off without interfering with production.
For the reading, we tried several times to find the best place to read code and verify that it was correct. Initially, we had one pack going down a chute to be read and we couldn’t position the reader accurately. Eventually, we found a place for the reader—a very small area where we could fit a camera within the equipment itself to read the pack as it went past, at a place where each pack would stop very briefly before moving on. We found that we could read it at that point.
PhM: What are the next steps? Are you using the equipment now?
J.C.: The equipment is still there but we’re not using it. We were just testing traceability from the production line to the hospital pharmacy . . . once it left here it was tracked by satellite, and was tracked to distributors, wholesalers and hospital pharmacies.
The next step for the Bridge traceability pilot will involve tracking from the pharmacy to the patient.
Overall, the challenge with traceability is to get wider industry buy-in to the requirement. Using data matrix on packs is a relatively straightforward process. Putting all the other elements in place will take longer but at least it will use standard, available technology. In the end, it will require government legislation to move forward.