Packing-Line Improvement Based on a Fault-Tree Analysis Approach

This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.
Mar 02, 2008
Volume 32, Issue 3

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

Figure 1: The packing process represented in a block diagram. QA is quality assurance.
The packing process in general can be summarized in a block diagram (see Figure 1). According to in-house procedures, the quality assurance (QA) department must verify the information from quarantined product and the corresponding packing material for approval. A product-release document is therefore indispensable to starting any product packaging activity. A packing-order document is created upon product release. This document matches the product vials and packing material that are involved in the process.

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.

Figure 2: Packing area layout. MUB is multiple unit box.
The original packing-area distribution was modified to physically separate the preparation of packing material from the labeling, imprinting, and manual packaging operations of the main packing line (see Figure 2). Note that the contiguous packing line included a Sensitive 350 labeling machine (Libra Pharmaceutical Technologies, Fairfield, CT) followed by a 6.65-m long conveyor with speed control to transport labeled vials to manual packaging operators. According to the original arrangement, one of the operators near the labeling machine (No. 8) acts as a buffer by collecting vials and returning them to the conveyor in groups of five. The other operator next to the labeling machine (No. 1) simultaneously configures and distributes empty MUBs using the same conveyor. The rest of the operators (Nos. 2–7) package product vials in individual cartons, including leaflets, placing the packed units into the MUBs in groups of 10.

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