Temperature mapping study
Purpose
To
lay down the procedure to prepare, review, approve and execution of Temperature
mapping study protocol and report.
Procedure:
Definition:
Temperature mapping: Documented testing that demonstrates with a high degree of
assurance that a specific process will meet its pre- determined acceptance criteria.
General
Checks:
Mapping
study shall be performed to ensure the uniformity of the temperature and/or
Relative Humidity and to identify the point for which monitoring of parameter
shall be performed on routine basis of the respective area as user
specification required.
Mapping
activity shall be performed by outside Agency.
Ensure
the calibration status of instrument for measuring and recording of the
activity.
Persons
performing the mapping study from external agency should have the valid training certificate.
Mapping
study shall be done in the hottest period/month of the year or whenever
required as per defined protocol which shall cover time period for mapping
study.
Criteria
for Mapping study:
Mapping
study shall be performed for all new constructed areas as well as season study.
In
addition, mapping study shall be carried out whenever significant modifications
are made to the controlled storage area.
Seasonal
variation shall be considered for mapping study of newly installed/modified
temperature storage areas.
In
laboratories temperature is required for routine activities. Temperature
mapping study shall be carried out once for new room and thereafter if any
modification done in the room.
Selection
of Data logger:
Data
logger shall be technically suitable for the specific mapping task and for the
intended operating environment.
The
data logger should provide a continuous reliable record of time temperature/RH
data.
The
data logger should have an appropriate temperature & RH range so that all
anticipated temperature & RH extremes can be recorded.
The
data logger should have user-programmable data sampling period, with time
intervals ranging from (10 Sec to 15 minutes) or more and sufficient memory for
he intended length of the study and the chosen recording interval.
The
data logger should have NIST-traceable at least 3-point calibration certificate with a guaranteed error of not more than ±
0.5°C (for temperature) and ± 5% RH (for Relative humidity) at each calibration point.
The
data logger should allow the recorded time –temperature/RH data to
be downloaded in computer system for subsequent analysis.
Location
of Data Logger:
Data
logger shall be affixed as per identification and justification location.
Data
logger shall be arranged in grid fashion along the width and length of the area
so that the area is reasonably covered.
Data
logger shall be located in area where greatest variability in temperature is
expected to occur in order to maximize available safe storage volume.
Distance
between each data logger shall be 5-10 meter.
Location
can be decided on the basis of shelving and produce may affect airflow.
Data
logger placement may also be considered near to return air.
Data
logger shall arrange vertically as follows:
If
the ceiling height is 3.6 meter or less, position data logger directly above
one another at high and level or as mentioned in protocol.
If
ceiling height is greater than 3.6 meter, arrange data logger in vertical
arrays at the bottom, middle and top of the space in grid fashion.
Duration
of mapping study:
Mapping
study shall be performed for 24 to 72 Hrs as per requirement.
Documentation:
Mapping
study shall be performed as per the approval protocol.Report shall be prepared
after execution of activity.
After
execution report shall be prepared by using same content given in protocol.
Copy
of calibration certificates of instruments, raw data of complete mapping and
summarized report provided by vendor shall be verify and attached with the report.
Re-validation criteria:
remapping shall be performing under the following criteria.
Any
major modification in area.
Mapping
study trigger from change control.
Hold
& cold spots need to be determined seasonally as they may be significantly
different in winter, summer & rainy season.
