Temperature Mapping Study & Qualification Protocol Procedure
Temperature Mapping Study & Qualification Protocol Procedure
GUIDELINES
ON
TEMPERATURE MAPPING
STUDY & QUALIFICATION
OF
COLD ROOMS,
WAREHOUSES, VANS,
TRUCKS, REEFERS,
REFRIGERATORS & BOXES
FOR
PHARMACEUTICAL
INDUSTRY
TABLE OF CONTENTS
1.
1.1.1. Why would you require Temperature Mapping Study (aka Temperature Distribution study)? .....3
1.1.2. How do we carry out temperature mapping study? .................................................................4
1.2.
1.2.1. Do you require a temperature mapping or temperature & humidity mapping? ..........................5
1.2.2. What is the recommended humidity level for storage of medicines? ........................................5
1.2.3. How to reduce the humidity for cold rooms and warehouses for medicine storage? ..................5
1.3.
1.4.
1.5.
How to decide the sampling interval of data collection for the mapping study ..........................6
1.6.
1.7.
Temperature mapping study / Temperature & Humidity mapping study for various assets ........7
2.
What is Temperature Qualification study? (or Temperature & Humidity Qualification study) ......9
2.1.
Difference between Temperature mapping study and Temperature qualification study ........... 10
2.2.
How to decide whether you need Temperature Mapping study or Temperature Qualification
Study? 10
2.3. ... Do you require a Temperature qualification study or Temperature and humidity qualification?
.............................................................................................................................................. 10
2.4.
2.5.
2.6.
3.
3.1.
3.2.
3.3.
3.4.
What is the validity period of a temperature mapping study and temperature qualification
study? 13
4.
How to improve the results of the test and eliminate chances of failure? ............................... 13
4.1.
4.2.
5.
Temperature mapping study and Temperature qualification study are carried out generally in
pharmaceutical industry. There are different kind of medicines and vaccines which need to
be stored and transported at certain temperatures. Majority of these medicines and vaccines
are under two categories viz. Those to be stored between 2 to 8 Degree Centigrade and
those to be stored between 15 to 25C.
It is important for the efficacy of the medicine that the
same be stored and transported at the recommended
temperature limits as above. If the medicine or vaccine
goes above these temperature limits, the medicinal
properties will be gradually lost and most importantly
the products will not show any indication that it has
been compromised. In such case the ultimate distributor
and user will be unaware of the efficacy of the medicine.
The storage is done in warehouses, cold rooms or
refrigerators and transportation is carried out in boxes,
vans, reefers and containers.
The whole set of study is carried out to analyze the temperature distribution in a warehouse,
cold room, refrigerator, van or reefer trucks to find out whether the temperature inside such
facility is always maintained between the desired temperature.
In such cases you need to ensure that the temperature inside the enclosed area is within
the desired limits. eg. If you want to keep the medicine between 2 to 8 C and you are
keeping inside a cold room, how do you ensure that all
the entire cold room is between these temperature
limits? You might be keeping the medicine at one shelf
inside the cold room. You will not have any idea
whether this particular place is within the limits.
Generally you will have an indicator connected to the
cooling unit to display the current temperature. This
display picks up the temperature just from one sensor
placed at a certain location near the duct opening of the
cooling unit, based on which the cooling unit has its
switch ON and OFF cycles. This might be indicating a
temperature between 2 and 8 C. Most of us tend to believe that this displayed temperature
is the temperature across the entire cold room.
However how about various shelves and corners of the cold room where you are keeping
your medicines which are far away from this particular sensor?
How does a third party like an auditor can check whether the entire cold room is under
correct temperature?
How can you ensure that the display at the front door is exact in relation with the
corresponding sensor?
How do you know about the variations when a door is opened? The sensor might be far
away from the door and hence may not reflect any variation. However it really happens that
the area near the door suddenly goes above 8C.
All these doubts can be clarified only through a temperature mapping study.
1.2.
The methodology is same as a temperature mapping study. However in this case humidity
also will be recorded for the same duration and will be analyzed. If there are dehumidifiers
already installed, the settings of the same also will be recorded to compare against the
actual results. Nowadays for many of the storage areas, humidity also is important and
hence need to be included in the study.
In order to decide the number and type dehumidifiers, special calculations need to be
carried out considering the present temperature, humidity, desired humidity etc.
Generally for ware houses, desiccant type and for cold rooms, rotary type dehumidifiers
have to be used.
1.3.
Documentation required prior to commencement of a
mapping study
The customer has to provide the layout drawing of the asset including details and locations
of cooling units and dehumidifiers if any.
Based on these documents a protocol will be prepared by us which has to be reviewed and
approved by the customer.
The tests will be carried out by us based on this protocol prior to commencement of the
temperature mapping study.
1.4.
The results of the distribution study will be either pass or fail. Also it can be fail or pass with
some deviations. The criteria for acceptance of the study will be defined in the protocol and
typical ones are as under:
a. All readings of the data loggers should be within the desired limits of temperature &
humidity
b. Mean Kinetic value should be within desired limits (We do not encourage this criteria
unless insisted by the client. However we will indicate the value in our reports)
c. During door opening tests, the values should be within limits and should return to
normalcy within the desired duration as defined in the protocol.
1.5.
How to decide the sampling interval of data collection
for the mapping study
Sampling interval is the frequency of data recording of
the data loggers. Generally the data loggers can be
programmed to record the data at different intervals
such as 10seconds, 30 seconds, 1 minute etc. If the
sampling interval of a temperature data logger is
programmed for 5 minutes it means that the
temperature is recorded every 5 minutes.
Sampling interval of data collection should be kept
ideally as follows for a temperature mapping study:
a. 3 minutes for 2-8 C assets such as cold rooms, vehicles, boxes, refrigerators etc.
b. 5 minutes for 15-25C vehicles.
c. 10-15 minutes for warehouses maintained at 15-25 C
This is mainly based on the goods to be stored inside the asset. Eg. If a medicine which
should not go above 8C for 2 minutes is stored inside a refrigerator, it means that you
should keep a sampling interval of at least 1 minute. For a medicine which is permitted to go
above 8C for 10 minutes, a sampling interval of 3 minutes is sufficient.
This also depends on the range of the temperature. 2-8 C is a very narrow range and can
go above this range even for minor fluctuations. Hence ideally a sampling interval should not
be more than 3 minutes.
For a warehouse, 15-25 C is a wider range and the rise in temperature will be slow. Hence
a sampling interval of 10 minutes is sufficient.
1.6.
From the summary of the reports of a temperature mapping study, the following details will
be useful for your practical applications
1. When you decide to place monitoring devices
such as data loggers or real time monitoring
devices, those should be placed in Hot and cold
points. Hot and cold points will be mentioned in
our reports.
2. The report will indicate the duration within which
the temperature will exceed the permitted levels
upon door opening. eg. if such duration is 5
minutes, you should take care that the door
opening should be for a very short duration.
3. The report will indicate the duration within which
the temperature will exceed the permitted levels in the event of power failure. So in
case of a power failure, you should not open the door and should be in closed
condition if you expect that power will be restored within such a duration. If you do
not expect power restoration within such a duration the medicines should be shifted
to an alternate facility such as a temperature controlled van or reefer.
1.7.
Temperature mapping study / Temperature & Humidity
mapping study for various assets
Brief details of the study for various kind of assets are detailed hereunder
The percentage loading can be decided by the client as per his usual loading pattern.
Sampling interval will be generally kept at 1-2 minutes.
b.
c.
d.
e.
The percentage loading can be decided by the client as per his usual loading pattern.
Sampling interval will be generally kept at 3 minutes.
1.8.
2.1.
Difference between Temperature mapping study and
Temperature qualification study
2.2.
How to decide whether you need Temperature Mapping
study or Temperature Qualification Study?
If you want to check only distribution of temperature & humidity, a mapping study is
sufficient. If you want to check whether the whole asset is designed, installed and operated
correctly, it is desirable to carry out a temperature qualification study.
A qualification study is considered to more of international acceptance. An auditor from
another part of the world may not be familiar with various installation and operational
parameters of the asset. If an asset is qualified the asset is considered to be a fully
satisfactory system.
2.3.
Do you require a Temperature qualification study or
Temperature and humidity qualification?
Please see our explanation for similar query under temperature mapping study.
If your major parameter is only temperature, they you may limit to a temperature
qualification study. If you also require humidity, a temperature & humidity qualification
study will be required.
2.4.
Advantages of a Temperature qualification study over a
mapping study
The temperature qualification study is considered more of international acceptance. So if
your clients and suppliers are from various countries it is preferred to have a qualification
process done. As an example each country has their own type of design, installation and
operation procedures for a cold room. Hence your client from another country may not be
familiar with such parameters in your country. If a temperature qualification study is carried
out on this cold room, the client need not check any details at all since the cold room is fully
qualified to ensure full compliance to keep a temperature between 2-8C
2.5.
Documentation required prior to commencement of a
qualification process
Prior to commencement of a temperature qualification study, we require the following
document/details from the customer.
a. The customer has to provide the layout drawing of the asset
b. All details of cooling units such as sl. nos., details of sensors, operation manuals,
design drawings etc. have to be provided.
c. Similar details of dehumidifiers also have to be provided.
d. All details of temperature monitoring systems (if any) to be provided.
Based on these documents a protocol will be prepared by us which has to be reviewed and
approved by the customer.
The tests will be carried out by us based on this protocol.
2.6.
3.1.
We are mentioning of small and medium sized vans. There are many reasons for failure of
these vehicles during a temperature mapping study and temperature qualification. The main
ones are listed here:
a. The temperature shown in the display unit of the cooling unit may not be matching
with actual inside temperature. Probably the sensor is reading is not correct. This can
happen for many reasons. Over a period of time the accuracy of the sensor may be
lost. Eg. the display unit might be showing 5C and the driver will be confident that
the cold cabin is at 5C. However it is possible that the inside temperature is at 7C.
In order to avoid such a situation place a data logger next to the sensor of the
cooling unit and record for few hours. Set the cooling unit at desired temperature.
After couple of hours download the data and analyze. The graph will be in
continuous up and down cycles. Check the highest and lowest temperature of these
cycles. If these values are close to the set point, it means that the sensor and display
unit are working correctly. Eg. if the set point is 5C, the highest and lowest readings
should be 7C & 4C. (This varies based on the type of cooling unit, programmed
setting of upper and lower cut off limits etc. However this will give an indication
about correlation of the displayed temperature and actual sensor temperature.
b. Temperature goes to extreme low and high points at all cycles. Eg. The set point is
5C. However the temperature goes regularly to 9C and 3C regularly. This
happened because the cooling unit is programmed accordingly. ie. It has a high cut
off at 4C above the set point and low cut off of 2C below the set point. This can be
programmed for 2C for both high and low cut off points. Thereafter the higher &
lower cut off will be 7 & 3C respectively. (This feature is based on the manufacturer
and models of the cooling unit)
c. Temperature on one end of the vehicle goes beyond limits. This happens mainly in
vehicles which has one cooling unit and having fan only at one end. It is possible
that the other end of the cold cabin is not properly receiving the air. If the fan unit is
not producing strong air flow it may happen. Otherwise air flow ducts will have to be
provided from the cooling unit to the other end of the cooled cabin. Thus the air will
be divided through multiple ducts and distributed at front and rear end of the
vehicle.
d. Temperature goes high at certain points during loaded test. This may happen mainly
due to limited air flow. During a loaded test (and during actual loaded conditions),
goods should not be placed directly in front of the air flow. Also sufficient space
should be left on all sides and on the top for efficient air flow.
3.2.
3.3.
3.4.
What is the validity period of a temperature mapping
study and temperature qualification study?
There are no general rules applicable for the same. However for a new facility we suggest
that the study report can be considered valid for a period of 3 years.
If any modifications are carried out related to shape and layout of the asset, modification or
replacement of cooling units, rearrangement of racks etc., the original report cannot be
considered valid. The reasoning is that any of these changes will affect the distribution of
temperature and humidity.
4.1.
4.2.
Before commencing the actual tests, we will sent you some data loggers for placing at
certain locations as per the drawings. The data need to be collected for a certain duration
and the data loggers have to be returned. We will analyze the data and will provide suitable
recommendations. Generally we include one trial study in our scope to assist customers (To
be finalized at the time of finalizing the order)