| Automated Cleaning | Manual Cleaning |
| Automated cleaning will usually provide reproducible results. | Manual cleaning is a universal practice within the pharmaceutical industry |
| Process control is inherent in
automated systems and process monitoring is frequently integral with the control system | There are many
pieces of equipment and portions thereof for which construction and/or configuration make
manual cleaning a necessity. |
| The validation of an automated
system requires that the cycle is proven to be rugged and will provide reproducible results
under a given range of operating conditions. | The control of manual cleaning is accomplished by operator
training, well defined cleaning procedures, visual examination of equipment after use and prior
to the next use, and well-defined change control programs. |
| Control system validation is a large part of the
validation of an automated cleaning system. | It may be desirable to identify
worst case cleaning situations (in terms of operator experience and/or cleaning methodology)
for validation purposes. |
| | With manual cleaning, concern must also be given to the ruggedness
of the method. Successful reproducibility is a function of strict adherence to written procedure |
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