The use of a single cleaning agent will greatly reduce the work required to determine if residues of
the agent remain after cleaning.
For multi-product facilities, it may be necessary to use several
different agents to remove the various types of excipients that are present in different products. When considering the product formulation and equipment groupings, it is appropriate to also consider and subdivide systems based upon the cleaning agents utilized on those systems.
The agent grouping should display analogous profiles in the ability to remove similar product formulations if all other cleaning method variables are the same.
Care must be taken to ensure that worst-case products are chosen.
Typically, this approach is best if used in combination with other groupings.
Groupings should help to develop baseline data on which to establish the ongoing validation program.
New products should be added to the grouping or tested if they fall outside of the established
baseline.
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