21cfr1271

§ 1271.195

21 CFR Ch. I (4–1–06 Edition)

(c) Operations. You must divide a facility used in the manufacture of HCT/
Ps into separate or defined areas of
adequate size for each operation that
takes place in the facility, or you must
establish and maintain other control
systems to prevent improper labeling,
mix-ups,
contamination,
cross-contamination, and accidental exposure of
HCT/Ps
to
communicable
disease
agents.
(d) Procedures and records. (1) You
must establish and maintain procedures for facility cleaning and sanitation for the purpose of preventing the
introduction, transmission, or spread
of communicable disease. These procedures must assign responsibility for
sanitation and must describe in sufficient detail the cleaning methods to be
used and the schedule for cleaning the
facility.
(2) You must document, and maintain records of, all cleaning and sanitation activities performed to prevent
contamination of HCT/Ps. You must retain such records 3 years after their
creation.
§ 1271.195 Environmental control and
monitoring.
(a) Environmental control. Where environmental conditions could reasonably
be expected to cause contamination or
cross-contamination of HCT/Ps or
equipment, or accidental exposure of
HCT/Ps
to
communicable
disease
agents, you must adequately control
environmental conditions and provide
proper conditions for operations. Where
appropriate, you must provide for the
following control activities or systems:
(1) Temperature and humidity controls;
(2) Ventilation and air filtration;
(3) Cleaning and disinfecting of
rooms and equipment to ensure aseptic
processing operations; and
(4) Maintenance of equipment used to
control conditions necessary for aseptic processing operations.
(b) Inspections. You must inspect each
environmental control system periodically to verify that the system, including necessary equipment, is adequate
and functioning properly. You must
take appropriate corrective action as
necessary.

(c) Environmental monitoring. You
must monitor environmental conditions where environmental conditions
could reasonably be expected to cause
contamination or cross-contamination
of HCT/Ps or equipment, or accidental
exposure of HCT/Ps to communicable
disease agents. Where appropriate, you
must provide environmental monitoring for microorganisms.
(d) Records. You must document, and
maintain records of, environmental
control and monitoring activities.
§ 1271.200

Equipment.

(a) General. To prevent the introduction, transmission, or spread of communicable diseases, equipment used in
the manufacture of HCT/Ps must be of
appropriate design for its use and must
be suitably located and installed to facilitate operations, including cleaning
and maintenance. Any automated, mechanical, electronic, or other equipment used for inspection, measuring,
or testing in accordance with this part
must be capable of producing valid results. You must clean, sanitize, and
maintain equipment according to established schedules.
(b) Procedures and schedules. You
must establish and maintain procedures for cleaning, sanitizing, and
maintaining equipment to prevent
malfunctions, contamination or crosscontamination, accidental exposure of
HCT/Ps
to
communicable
disease
agents, and other events that could
reasonably be expected to result in the
introduction, transmission, or spread
of communicable diseases.
(c) Calibration of equipment. Where appropriate, you must routinely calibrate
according to established procedures
and schedules all automated, mechanical, electronic, or other equipment
used for inspection, measuring, and
testing in accordance with this part.
(d) Inspections. You must routinely
inspect equipment for cleanliness, sanitation, and calibration, and to ensure
adherence to applicable equipment
maintenance schedules.
(e) Records. You must document and
maintain records of all equipment
maintenance, cleaning, sanitizing, calibration, and other activities performed
in accordance with this section. You

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