Three broad definitions of cleaning processes follow. The distinctions between these processes is
critical to the establishment of an appropriate cleaning validation program.
1.Manual
Manual cleaning is typically defined as the direct cleaning of equipment by a trained
equipment operator using a variety of hand tools and cleaning agents.
Although some process parameters may be monitored by gauges, the regulation and control of these parameters is the responsibility of the operator.
Critical cleaning parameters for manual cleaning may include: the volume of cleaning agents,
volume of rinse water, temperature of wash and rinse solutions, duration of wash and rinse
cycles, pressure of solutions, and detergent concentration.
It is important to specify in writing the extent of the equipment disassembly to ensure the reproducibility of the cleaning process.
In a manual cleaning validation program, the critical factor is the ability to provide a
reproducible process.
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.
One benefit of manual cleaning is that the operator is cognitive and able to adjust to and report changing conditions.
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