Biomedical Engineering Reference
In-Depth Information
Any of these soils can contaminate the regulated product and
must be reduced to an acceptable level.
4.2.1 Cleaning and sanitizing activities are
controlled by SOPs
Facilities are to be cleaned and sanitized according to cleaning
and sanitizing SOPs. The CFR stipulates that there must be
written procedures assigning responsibility for sanitation
and describing in suffi cient detail the cleaning schedules,
methods, equipment, and materials to be used in cleaning the
buildings and facilities. The CFR continues “such written
procedures shall be followed.”
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An illustrative example of
such a cleaning and sanitizing procedure is included in the
next part of this chapter.
Cleaning and sanitizing of facilities occur according to
specifi c schedules that are typically appended to the cleaning
and sanitizing SOP. These schedules allow the rooms to be
used for production purposes, while still permitting the
rooms to be cleaned and sanitized. Not only are the rooms
scheduled for cleaning and sanitizing, but the specifi c surfaces
within each room are also scheduled. For example, cleaning
schedules for ceilings are different from cleaning schedules
for fl oors. Ceilings tend to bear less soil than do fl oors, and
are in less close proximity to the product. Thus fl oors will be
the focus of more intensive and frequent cleaning
and sanitizing efforts than will ceilings. This differential level
of effort will be refl ected in the cleaning and sanitizing
schedules for each room. Illustrative examples of a cleaning
schedule and a sanitizing schedule follow as Figures 4.5(a)
and 4.5(b).
All cleaning and sanitization activities must be documented
as soon as completed, in the appropriate cleaning log and
