Basic Documentation

applied to the device. Alarms should be checked for
correction function against specified design
documents.
Written Procedures and Records
Written procedures should be available to describe
the control and monitoring of storage temperatures
and the calibration of measuring devices.
Procedures should include alert and action limits
and the corrective actions to be taken if the
temperature falls outside these limits.
Designate one person to act as lead-person to
review monitoring records at least monthly. The
back-up person should learn proper storage
procedures and be familiar with monitoring reports.
The review of records should be part of the quality
control program.
Training
Suitable training should be provided for personnel
who handle medicinal products. Personnel should
know how to monitor temperatures and how to react
to situations where adverse temperatures are
identified. Procedures for temperature monitoring
should include:
 Frequency of monitoring
 Location of recording devices
 Acceptable temperature limits
 Calibration of monitoring devices
 Temperature mapping
 Alarms and corrective actions taken in event of
an temperature excursion
 Records
Qualification of Cold Equipment
Page 4 of 6 Siemens Industry, Inc.
Large refrigerators (in excess of 6 m
2
) or walk-in
cold rooms should undergo an initial thermal
mapping in their empty and full state. After that, the
temperature distribution should be checked annually
under normal use conditions. For walk-in units,
thermal mapping should be repeated, if the unit has
undergone significant repair, replacement of
refrigeration or changes to internal storage layout.
Walk-in units should use multiple sensors for
temperature monitoring.
Compromised Temperature
Conditions
Excursions above or below established limits require
a history leading up to and including the period out
of tolerance and a documented rational for the
excursion, including corrective actions.
Reliable Emergency Power
Emergency power should be available to all critical
equipment during power outages. A gap analysis
should be performed on the emergency power
system to match critical equipment and systems
needed in an extended emergency against the
equipment and systems actually on the emergency
power system. This kind of planning will help assure
that emergency power feeds critical systems.
Mean Kinetic Temperature (MKT)
The MKT is a calculated, fixed temperature that
simulates the effects of temperature variations over
a period of time. MKT is not a weighted average.
MKT gives more weight to higher temperatures than
the arithmetic mean calculation. By giving a unequal
weighting to higher temperatures in the series, MKT
takes into consideration the cumulative thermal
stress experienced by the product at varying
temperatures during storage and distribution.
The temperatures for calculating MKT can be
collected using the building automation system that
trends temperatures at frequent intervals (e.g., every
15 minutes).
8
Trend data can be downloaded to a
computer for processing.
Design Considerations
The following list describes important design criteria
for monitoring critical storage areas:
 Temperature sensors shall be NIST-certified or
guaranteed by manufacturer to meet NIST
standards. Temperature sensors should have an
accuracy of ± 0.25°C
 Storage unit temperature should be readable
from the outside of the unit (for example,
refrigerator, freezer or incubator).
8. Blackburn, Timothy, USP-Controlled Room Temperature,
Ispe Carolina-South Atlantic Chapter Newsletter,
Spring/Summer 2002, Vol.9, No.3
Document No. 1
49-925