Development of a process to clean the outside of the closed injectable ampoules.

Abstract

The project presented below was generated from a real need of a pharmaceutical plant to improve the production of one of their products. The proposed improvement project affects the manufacture of injectable ampoules, exactly the external washing of them once been filled and sterilized. The external ampoule’s washing is necessary because they will pass through an inspection stage where it will be detected if there are any impurities inside the ampoules. If ampoules are not externally clean the inspection line cannot distinguish whether the product have internal impurities or external, therefore, all of this ampoules will be rejected due to they will be unfitted for consumption. This external dirt mainly result during the sterilization stage due to rising temperatures and especially the pressure some of the ampoules do not withstand these conditions and endlessly they breakdown. Until this moment, the company uses the autoclaves to carry out the ampoules external washing. In this project three different ideas for improving this process stage are proposed. The first two ideas, propose improving the ampoules external washing using elements and equipment the plant already have, meanwhile the third option proposes a totally innovative washing design. The first option studied was the possible modification and improvement of the autoclave cycle to ensure, as already known, that there is no possible way an autoclave would carry out a good external washing. Its use is unique and exclusive to perform sterilizations. The second option was proposed was to optimize the ampoules trays. They are used for transporting the ampoules between the different stages of the process. Trays are holoed stainless steel "boxes". Their holes allow draining any remaining water from sterilization, and until now, from the washing. Thus, their dimensions, material and even the pass area of water through it were studied, but this option presented limitations regarding its improvement as it was seen that all the were almost ideal for the process. Finally, the last option was to design an ampoule’s washing tunnel. Using the washing tunnel it was ensures a good external wash of the ampoules so they would pass through the inspection line without any problem. This last option was the one presenting more improvements related to cost savings and especially time spent for company’s workers hand-washing those ampoules detected for the inspection line one by one.