Cleaning validation for a new pharmaceutical molecule

As part of the introduction of a manufacturing and packaging suite for a new semi-solids manufacturing plant, the client needed an expert to introduce the new molecule into its cleaning validation program and to qualify its new clean-in-place (CIP) system.

Genipro was mandated to complete the operation qualification of the automated CIP system and proceed with the cleaning validation of the equipment train in contact with the product. This validation had to cover the CIP cleaned equipment train as well as the manually cleaned equipment and utensils.

The first challenge was to fully understand the work previously performed by the client in order to ultimately present a coherent validation file. Also, given the complexity of the equipment to be cleaned, we developed different sampling methods depending on the accessibility of the sites (swab sampling, CIP rinsing water, syringe rinsing for small areas that could not be swabbed). In addition, some gaps in the drainability of the system had to be remediated by manually disassembling certain equipment sections to ensure adequate drying of all surfaces. Since the equipment trains were used in different configurations of manufacturing campaigns, several protocols were developed to adequately cover all combinations. The client greatly appreciated our practical experience, which allowed us to apply simple and inexpensive solutions to complex problems.