Current through Register Vol. 48, No. 39, March 25, 2024
Subpart 1.
Scope.
This part applies to all devices that may not be the actual
test instrument, but that are necessary to support laboratory operations, if
quantitative results are dependent on their accuracy. Such devices include, but
are not limited to, balances; ovens; refrigerators; freezers; incubators; water
baths; temperature measuring devices, including thermometers and thermistors;
thermal/pressure sample preparation devices; autoclaves; and volumetric
dispensing devices, such as Eppendorf or automatic diluter/dispensing
devices.
Subp. 2.
Requirements.
A. Equipment must
be operated by trained personnel. Up-to-date instructions on the use and
maintenance of equipment, including any relevant manuals provided by the
manufacturer of the equipment, must be readily available for use by the
appropriate laboratory personnel.
B. All equipment must be properly maintained,
including inspection, calibration, and cleaning. Maintenance procedures must be
documented. Calibration of balances, weights, temperature recording devices,
light sources, and detectors must be appropriate to the required precision and
accuracy of the method. Calibrations must be performed at least annually and
must be traceable to appropriate standards.
C. Records must be maintained for each major
item of equipment, including software. The records must include:
(1) the identity of the item of equipment,
including software;
(2) the
manufacturer's name, type identification, and serial number or other unique
identification;
(3) documentation
that equipment complies with the manufacturer's specification;
(4) the current location within the
laboratory;
(5) the manufacturer's
instructions, if available;
(6)
dates, results, and copies of reports and certificates of all calibrations,
adjustments, and acceptance criteria and the due date of the next
calibration;
(7) the maintenance
plan and maintenance carried out to date, documentation on all routine and
nonroutine maintenance activities, and reference material
verifications;
(8) any damage,
malfunction, modification, or repair to the equipment;
(9) date received and date placed in service
or the date on which its first use or repair was recorded; and
(10) if available, condition when received,
such as new, used, or reconditioned.
Subp. 3.
Frequency of
calibration.
A. All support equipment
described in subpart
1
must be calibrated or verified at least annually, using National Institute of
Standards and Technology (NIST) traceable references when available, over the
entire range of use.
B. On each
working day, balances, ovens, refrigerators, freezers, and water baths must be
checked in the expected use range with NIST traceable references, when
available.
C. Mechanical volumetric
dispensing devices including burettes, except Class A glassware, must be
checked for accuracy at least quarterly. All glassware, including glass
microliter syringes used for calibration, must be checked for accuracy and
documented before its first use in the laboratory if the glassware does not
come with a certificate attesting to established accuracy.
D. For chemical and biological tests using an
autoclave, the temperature, cycle time, and pressure of each run must be
documented by the use of appropriate chemical indicators, temperature
recorders, and pressure gauges.
E.
Volumetric equipment must be calibrated as follows:
(1) equipment with movable parts, such as
automatic dispensers, dispensers/diluters, and mechanical hand pipettes, must
be calibrated quarterly;
(2)
equipment such as filter funnels, bottles, non-Class A glassware, and other
marked containers must be calibrated once per lot prior to first use;
and
(3) the volume of the
disposable volumetric equipment such as sample bottles, disposable pipettes,
and micropipette tips must be checked once per lot.
F. Dial thermometers must be checked on a
quarterly basis. All measurements must be recorded. When the thermometer is
used for microbiological methods, all thermometers must be calibrated on an
annual basis against a NIST thermometer. When the thermometer is used for
nonmicrobiological methods, the thermometer is valid for the time period
specified on the vendor's certificate. If a time period is not specified, the
thermometer must be calibrated on an annual basis against an NIST
thermometer.
Subp. 4.
Acceptance criteria.
A. The
results of calibrations must be within the specifications required of the
application for which the equipment is used.
B. The acceptability for use or continued use
must be according to the needs of the analysis or application for which the
equipment is being used.
C. When
the results of calibration of support equipment are not within the required
specifications, the laboratory must remove the equipment from service until
repaired.
D. Records must be
retained to document equipment performance.