Materials of Construction

1.The materials of construction of the equipment should be considered carefully when
establishing a cleaning validation program.

2. The attributes of the surface to be cleaned will define the residue to surface interactions, identify possible contaminants and point to areas
which may not be readily cleaned or accurately sampled.

3.The CGMPs (211.65) state that,
"a) Equipment shall be constructed so that surfaces which contact components, inprocess
materials, or drug products shall not be reactive, additive or absorptive so as
to alter the safety, identity, strength, quality or purity of the drug product beyond
official or other established requirements.
"b) Any substances required for operation, such as lubricants or coolants, shall not come
into contact with components, drug product containers, closures in-process materials,
or drug products so as to alter the safety, identity strength, quality or purity of the
drug product beyond official or other established requirements."

4.Equipment should not be reactive, additive or adsorptive with the process materials which
contact them.

5.The use of porous surfaces for multiple products should be avoided (filters,
filter bags, fluid bed drier bags, membrane filters, ultra filters).

6.Any surfaces which have these properties will require review during cleaning validation evaluations to ensure adequate
product removal and minimize the potential for cross-contamination.

7.The interaction of cleaning agents with surfaces that are likely to display these properties (e.g., seals, gaskets,
valves) should be assessed.