Basic Documentation

Siemens Industry, Inc. Page 7 of 8
Document No. 149-224
• Temperature and Humidity monitoring
equipment must be calibrated or verified for
accuracy at least every 12 months or as
recommended by the manufacturer.
• Differential pressure monitoring equipment must
be calibrated or verified for accuracy at least
every 6 months.
Monitoring Controlled Storage
Areas
USP <795> and <797> require documentation that
medications are stored under necessary conditions
to ensure stability.
Controlled storage areas in the pharmacy should be
monitored at least once per day and the results
documented on a temperature log. If the facility uses
a continuous temperature-monitoring device or
system, then personnel must verify at least once
daily that the recording device is functioning
properly.
Storage conditions (as defined in USP <659>) are
as follows unless more restrictive conditions are
provided from the manufacturer:
Component
°F
°C
Freezer
-13 to 14
-25 to -10
Refrigerator
36 to 46
2 to 8
Cold
< or = 46
< or = 8
Cool
46 to 59
8 to 15
Room
Temperature
Prevailing area
Prevailing area
Controlled Room
Temperature
68 to 77
20 to 25
Warm
86 to 104
30 to 40
Excessive Heat
> 104
> 40
Dry Place
Average relative humidity not > 40%
Storage area humidity should be maintained at or
below 60%.
Audible and visual indication of controlled storage
temperature alarms should be provided for
healthcare workers, and the time of the alarm should
be recorded. Integration of controlled storage area
monitoring into the BAS allows historical data,
alarms, and alarm acknowledgements to be
collected and archived to document compliance with
USP requirements.