Global running regulatory deadlines for pharmaceutical serialization are putting heavy pressure on the production & packaging as well as IT & QA people in pharmaceutical manufacturers and automation integrators alike. Implementing serialization is relatively easy if one has ample room and financial resources to build a new end for a production or packaging line, but many production sites are not so spacious. Often it isn’t financially feasible to replace all of the old equipment, either. Thus discussion about retrofit serialization installations.
Machinery manufacturers are happy to sell new machinery. Installing new machinery to replace existing ones is also quite a straightforward project, given enough room. When there is a case for retrofit engineering, i.e., installing as little new equipment as possible, more automation engineering skills are required. An experienced automation integrator is able to help the pharmaceutical manufacturer through this project, by pointing out the possibilities and providing the skills needed.
At an old manufacturing site most or all of the space is already booked by the existing production and packaging equipment. There may be little room for any new machinery. Adding new functionality to the packaging line may thus need custom design to retrofit due to spacial constraints.
If the production is not already 24/7, there also may be a possibility to unite two production lines with a common packaging end. This helps control the costs to make it financially more feasible to upgrade the level of automation.
In some cases, much of the packaging work is done manually, especially in small-scale production. In some countries, there may be an attitude that with the low local employee costs, automation would not make sense. When a new process phase is introduced, e.g., serialization and aggregation, the situation may change profoundly. As in one of the sites I have visited, there were 8 people in the end of the production line packing the medicines to cartons with leaflets, and then adding the cartons to cases and sealing them. When serialization and aggregation is brought to the same table, even when done manually or semiautomatically, there will be several issues that affect the production economy:
- The more people, the more manual or semiautomatic serialization and aggregation stations, thus higher equipment cost.
- The new process step might make the job unfeasible to the current personnel given the production line output. There might thus be a need to add more people, and thus possibly even more new equipment.
- The new process step increases the risk of human errors.
- There might not exist extra space for the new personnel in the current packaging room. Adding extra room may be expensive or require difficult reorganization of other production rooms.
In this case, the solution might not be to add extra people and tear down the outer wall of the factory building to build more room. The most feasible solution might be to add an automatic cartoner and then have fewer people, maybe two, with semiautomatic case aggregation stations. No need for extra room then.
For custom and retrofit production line upgrades, services of an experienced full-service automation integration company are thus required. With experience from 30 years in the pharmaceutical industry, and of 800 production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization and automation projects. We have experience from various retrofitting projects. Call us for professional help!
Iiro Jantunen, D.Sc.
Chief Technology Officer
+358 44 7868 215