Packaging is the final step in obtaining a finished pharmaceutical product. It is important because it ensures product integrity, identification, and presentation, including primary information for the patient (1).
For this reason, the packaging process should be analyzed, and manufacturers should take into account the occurrence of deviations such as equipment and component failures, human error, operational errors, and other deviations that negatively affect the final process result (2–4). Risk analysis (RA) methods are valuable tools for mitigating fault events by focusing on the cause–effect interrelations that create them. RA methods thus facilitate fault elimination or, when faults cannot be eliminated, fault reduction.
In today's pharmaceutical industry, most processes are conceived and designed with a high level of automation to minimize operator intervention. Nevertheless, economic considerations lead companies to retain manual operations in certain situations. The packing process that is the subject of this study is one example. In such a process, a fault-tree analysis (FTA) approach can greatly help determine critical process points. The approach also helps manufacturers introduce barriers against equipment and operator failure and minimize their probability of occurring (5, 6). Following these considerations, the packing line was arranged, bearing in mind the potential failures to which the final result could be exposed. The arrangement was validated by challenging the process to demonstrate its effectiveness.Packing process description and considerations
Refrigerated product vials must pass a room-temperature acclimatization stage to eliminate external moisture on the vials before they are labeled. All other product vials are directly transferred together with label rolls for automatic labeling and imprinting. Printed packing material such as labels for multiple unit boxes (MUBs) and shipping boxes, as well as cartons and leaflets, are semiautomatically imprinted, folded, identified, and prepared as needed. These items are then temporarily stored together with the rest of the materials until vial labeling and manual packaging begins.