A Look at Cleaning Effectiveness in Automated Dissolution Systems

Cleaning in any Good Manufacturing Practice (GMP) laboratory is an important aspect of the analytical experiment. The laboratory must ensure the equipment does not contain residual active pharmaceutical ingredients (APIs) or impurities that may affect the outcome of any current or future experiments. While this is standard practice for GMP manufacturing operations, common laboratory equipment is often held to less stringent standards. The potential manhours lost due to investigations for extraneous peaks and contamination can be significant and cause delays in releasing product. Potential compliance issues related to ineffective cleaning are particularly important for dissolution instrumentation. Our laboratory has modeled the challenges of cleaning automated dissolution systems using representative soluble and poorly soluble APIs. Poorly soluble drugs often entail the use of surfactants in the dissolution media which also have a potential carryover issue. Using a manufacturing cleaning validation based approach, the study discussion presented will address the cleaning effectiveness for both sample and media considerations.