Approach for selection of cleaning media or solvent for cleaning validation
The selection of the
cleaning media shall be carried out based on following, and shall be documented
in Analytical Method Validation Protocol and Report.
- Solubility
criteria
- Solvent
selection shall be derived from manufacturing process.
- Based
on the available literature or available information on the internet.
- More
cleaning effectiveness with optimum qty.
- Less
hazardous
- Cost
effectiveness
- Easy
to handle and available.
- Past
experience about the process
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