Uploaded on Jul 5, 2022
temperature mapping study and protocol procedure
DETAILED PROCEDURE
AND GUIDELINES
ON
TEMPERATURE
MAPPING STUDY &
QUALIFICATION OF
COLD ROOMS,
WAREHOUSES, VANS,
TRUCKS, REEFERS,
REFRIGERATORS &
BOXES
FOR
PHARMACEUTIC
AL INDUSTRY
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
TABLE OF CONTENTS
1. Temperature Mapping Study / Temperature & Humidity Mapping
study...................................3
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. What is temperature and humidity
mapping study? ................................................................5
1. Do you require a temperature mapping or temperature & humidity
mapping?..........................5
2. What is the recommended humidity level for storage of
medicines? ........................................5
3. How to reduce the humidity for cold rooms and warehouses for medicine
storage?..................5
1.3. Documentation required prior to commencement of a mapping
study......................................6 1.4. Acceptance criteria for the mapping
study?............................................................................6
1.5. How to decide the sampling interval of data collection for the mapping
study ..........................6 1.6. How to use the results of temperature mapping
study ............................................................7
1.7. Temperature mapping study / Temperature & Humidity mapping study for various
assets ........7 1.7.1. Temperature mapping study of Reefer trucks &
vans..............................................................7
1.7.2. Temperature mapping study of a ware
house ........................................................................8
1.7.3. Temperature mapping study of Cold
room .............................................................................8
1.7.4. Temperature mapping study of a
refrigerator.........................................................................8
1.7.5. Temperature mapping study of a shipping
box.......................................................................8
1.8. Reports generated in Temperature Mapping
study .................................................................9
2. What is Temperature Qualification study? (or Temperature & Humidity Qualification
study) ......9
1. Difference between Temperature mapping study and Temperature qualification study
...........10
2. How to decide whether you need Temperature Mapping study or Temperature
Qualification Study? 10
3. ... Do you require a Temperature qualification study or Temperature and humidity
qualification?
..............................................................................................................................................
Vacker1 L0LC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone :4 (+. 971) A4 d2v 6a6n 1t1a g44e s l Faoxf : (+a9 71)T e4 m2 6p6e rature qualificatioGnr oups t Ouudry o fficoevs e: rU AE a(C orpm. Oaffippcein),g In dia, Oman ,
11 55
email:sales.uae@stvuadcyke .r.g.l.o..b.a..l..c..o.m...................10
Kuwait, USA
w
5.Documentation required prior to commencement of a qualification ww
.
process ...........................11 2.6. Reports of a Temperature qualification v
a
study .......................................................................11 3. Reasons for failure of a Mapping c
k
study ................................................................................11 e
r
3.1. Reasons for failure of mapping study of a gl
van......................................................................11 o
b
3.2. Reasons for failure of mapping study of a cold a
l
room ............................................................12 .
c
3.3. Reasons for failure of mapping study of a Ware o
house .........................................................12 m
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. Advantages of a trial
study .................................................................................................13
4.2. How to carry out a trial
study? ............................................................................................14
5. Documents related to Mapping study &
Qualification ............................................................14
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
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 25°C.
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.
1. Temperature Mapping Study / Temperature & Humidity
Mapping study
This article brief about mapping study for Temperature & Humidity
1. Temperature Mapping Study / Temperature distribution
analysis
Firstly we will explain about temperature mapping study and
thereafter about temperature & humidity distribution.
1. Why would you require Temperature Mapping
Study (aka Temperature Distribution study)?
If you are involved in manufacturing, transportation, storage or distribution of
medicines and vaccines, you will be interested to know more about
temperature mapping study. In all these cases your medicine is kept inside an
enclosed area such as a warehouse, cold room, temperature controlled van,
reefer truck, refrigerator, insulated boxes etc.
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
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 8°C.
All these doubts can be clarified only through a temperature mapping study.
1.1.2. How do we carry out temperature mapping
study?
In principle a temperature mapping study involves recording the temperature of
the cold compartment under various conditions. The data will be recorded for
days or weeks as per the nature of the asset. Numerous temperature data
loggers will be placed inside the testing area at various heights and data will be
continuously recorded. Depending on the nature of the property, the following
conditions will be tested:
a. Testing under empty conditions to analyze the distribution of
temperature when there are no loads in the area.
b. Testing under 60% loaded condition to analyze the distribution when
the area is loaded up to 60% of full capacity.
c. Testing under 100% loaded condition to analyze the distribution when
the area is
loaded in full capacity.
d. Door opening test to understand the effects on temperature during and
after a door opening.
Vacker LeL.C lP PoOw Beorx 9fa24il3u8r el D tuebsait l toUA aEnalyze the effects in the event of a power failPuarrte o.f VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 f. Startup test to check the time required for stKaubwialiitz, iUnSgA of the temperature
email:sales.uaine@sivdacek etrhgleob aal.rceoma. w
w
g. Recovery test to check the time taken for temperature recovery after a w
.
door opening. v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
2. What is temperature and humidity mapping study?
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.
1. Do you require a temperature mapping or
temperature & humidity mapping?
As mentioned earlier, this need to be decided by the manufacturer of the
medicines or as per your internal quality policy. For a warehouse,
generally it is preferred that humidity also be included in
the study because a warehouse is directly
affected by the external ambient conditions. For
a cold room the humidity can go to extreme high
levels of up to 100% because of its nature of
operation. Generally the door of the cold room
opens to a warehouse which is at a higher
temperature. Since the cold room is at a lower
temperature, it will attract the moisture and
hence will always have a higher humidity. Hence
irrespective of the
medicine being kept in the cold room, it is ideal that the cold room be analyzed
for humidity as well. However this can be decided by you and your pharma
manufacturer.
We recommend that for warehouses and cold rooms temperature and humidity
mapping study need to be carried out. For vans, reefers, refrigerators and boxes,
only temperature mapping study might be sufficient unless otherwise specified.
2. What is the recommended humidity level for
storage of medicines?
This generally depends on the type of medicine and the packaging being kept in
the storage area either for cold room or warehouse. Hence this is generally
recommended by the medicine manufacturers. Generally most of the
manufacturers are recommending that the humidity should be maintained under
a maximum limit of 65% under all conditions.
3. How to reduce the humidity for cold rooms
and warehouses for medicine storage?
Humidity can be reduced mainly utilizing
dehumidifiers. These are electrical devices which
absorb humidity from the air and convert it into
water. The water thus extracted can be removed
either manually or automatically. In the
automatic method there is a water pump
Vackaetrt LaLcCh el PdO t Boo xt h92e4 3d8e lh Duumbaii dl ifiUAeEr which will pump the Part of VackerGlobal
Phonwe a: (t+e9r7 1to) 4 a 2n 6 6e 1x1t e4r4n al lF aoxu : t(l+e9t.7 1In) 4 t 2h 6e6 manual method Group Our offices : UAE (Corp. Office), India, Oman ,
11 55
the wa Kuwait, USAemail:sales.uaet@evra cgkeertgslo bfialll.ceodm up in a try underneath and w
has to be manually drained periodically. w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
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 Acceptance criteria for the mapping
. study?
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
. for thceo lmleacptipoinng 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
mapap. in3g m stinuudtye:s for 2-8 °C assets such as cold rooms, vehicles, boxes,
refrigerators etc.
b. 5 minutes for 15-25°C vehicles.
c. 10-15 minutes for warehouses maintained at 15-25 °C
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
This is mainly based on the goods to be stored inside the asset. Eg. If a medicine
which should not go above 8°C 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 8°C 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. How to use the results of temperature
mapping study
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
clos1e.d7 condTiteiomn pife yroaut uerxep emcta tphpati npgo wsetru dwyill /b Tee rmesptoerreadt uwriteh i&n such a
dur.ationm. aIfp ypHoiunu gmd osi dt uintodyty e fxopre cvta proiowuesr aressstoertastion within such a duration
the medicines should be shifted to an alternate facility such as a
temperature controlled van or reefer.
Brief details of the study for various kind of assets are detailed hereunder
1.7.1. Temperature mapping study of Reefer trucks
& vans
For all type of vehicles, primarily the following tests are carried out:
a. Distribution analysis under empty conditions (24 hours)
b. Distribution analysis under 60% loaded conditions (24 hours)
c. Distribution analysis under full load conditions (24 hours)
d. Power failure test
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
e. Door opening test
The percentage loading can be decided by the client as per his usual loading
pattern.
1.7.2. Temperature mapping study of a ware house
For a warehouse the following tests are carried out as part of a temperature
mapping study
a. Temperature and humidity distribution analysis is carried out under
loaded conditions.
b. Door opening tests to analyze the effects
For an existing warehouse it will be difficult to carry out other tests such as
empty test, power failure test etc. since it may be difficult to remove the existing
goods form the warehouse. For a warehouse the distribution analysis is carried
typically for 7-14 days. The tests should also include holidays so that the
patterns can be analyzed.
Sampling interval of data collection should be kept ideally at 10-15 minutes.
1.7.3. Temperature mapping study of Cold room
For all type of cold rooms, primarily the
following tests are carried out:
c. Distribution analysis under empty
conditions (24 hours)
d. Distribution analysis under 60%
loaded conditions (24 hours)
e. Distribution analysis under full load
conditions
(24 hours)
d. Power failure test
e. Door opening test
The percentage loading can be decided by the client as per his usual loading
pattern. Sampling interval will be generally kept at 3 minutes.
1.7.4. Temperature mapping study of a refrigerator
For refrigerators, primarily the following tests are carried out:
f. Distribution analysis under empty conditions (24 hours)
g. Distribution analysis under 60% loaded conditions (24 hours)
h. Power failure test
i. Door opening test (for different durations such as 60 seconds, 120
seconds, 180 seconds etc., since for a refrigerator the door opening will
be more frequent
compared to other assets)
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.
1.7.5. Temperature mapping study of a shipping box
VackFeor rL LsC l PO Box 92438Phone : (+9h7i1p) p4i 2n g66 b1o1 x4,4 t
lh Dul eFa
b
xf
aoil ll oUwAiE : (+971n)g 4 2te 6s6ts are carried out:
Part of VackerGlobal
Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:saleas.. uaDe@isvtarcikbeurgtlioobnal .aconmalysis under empty conditions (24 hours) w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
b. Distribution analysis under 60% loaded conditions (24 hours)
c. Power failure test (for active cooling boxes)
d. Door opening test
e. For active boxes, the tests will be conducted inside a van as well as
inside a warehouse
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. Reports generated in Temperature Mapping study
The reports of a mapping study will include the following details:
f. Temperature distribution – Pass /Fail
g. Humidity distribution – Pass /Fail
h. Hot and cold points of the asset. These will
be the hottest and coldest points of the
area. Data loggers need to be placed in
these areas
i. Analytical graphs for all the tests
j. Any recommendations for improvement
k. Time taken to reach the desired
temperature after start up
l. Duration for which the temperature
remains within the limits after a power
failure
m. Duration within which the temperature
exceeds the limits during a door opening
2. What is Temperature Qualification study? (or
Temperature & Humidity Qualification study)
Temperature qualification study is a very detailed sequence of tests and analysis
to ensure that the asset is designed and installed in such a way that it is capable
of maintaining the desired temperature. After these series of test and verification
the asset is certified to be qualified for achieving and maintaining the desired
levels of temperature and humidity levels. The various tests covered under the
qualification process in general are as under:
n. Design qualification process – to verify the equipment are designed to
generate the desired temperature and humidity conditions
o. Installation qualification process – To verify whether the installation is
carried out as per the design and as per the installation procedures
recommended by the
respective manufacturers of critical equipment.
c. Operation qualification process – To verify that the operations are carried
out as per the recommended procedures of the manufacturers of the
critical equipment
d. Document verification – To verify whether all documents are maintained
Vacker LLC lb PyO tBhoex 9u2s43e8r l Dubai l UAE Part of VackerGlobal
Phone : (+971in) 4c l2u 6d6i n11g 4S4O lP F,a xc a: l(i+b9r7a1t)i o4 n2 6c6e rtificates etc. Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 e. Temperature mapping study (and Humidity ifK urweaqitu, iUrSeAd) – This test is
email:[email protected] w
more or less same as defined in the first part of this article. w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
2.1 Difference between Temperature mapping
. Tempsetruadtyu raen qdualification study
In a temperature mapping study, only distribution
of temperature & humidity are analyzed. This
study makes sure that the distribution is always
within the permitted range of temperature and
humidity as applicable. However the mapping
study does not check various criteria such as SOP,
whether installation has been done correctly,
whether the machines are working as per the
design, whether written procedures are
maintained, whether these written procedures are
sufficient etc. All such parameters are covered in
a temperature qualification study.
A temperature qualification study incudes mapping
study, but not vice versa.
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.
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
2.4 Advantages of a Temperature qualification study
qualification study will be required.
. mappoivnegr satudy
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 2-8°C
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
2.5 Documentation required prior to
. qualicfiocmatmioenn pcreomcensst of a
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. Reports of a Temperature qualification study
The reports of a temperature qualification
study will contain the following details in
general. Please note these may vary
depending on the nature of the asset.
e. Design qualification process – Pass or
Fail
f. Installation qualification process – Pass
or Fail
g. Operation qualification process – Pass or
Fail
h. Document verification – Pass or Fail
i. Empty mapping study – Pass or Fail
j. Loaded mapping study – Pass or Fail
k. Power failure test results
l. Recovery test results
m. Start up test results
n. Hot and cold points
o. Deviation if any
p. Recommendations
q. Corrective actions
If all the above tests are passed satisfactorily during the temperature qualification
study, we issue a certificate indicating that the asset is fully qualified. The details
of the asset will be indicated in the certificate.
3. Reasons for failure of a Mapping study
Common reasons for failure of a temperature mapping study or a humidity
mapping study are listed here:
1. Reasons for failure of mapping study of a van
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:
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
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
5°C and the driver will be confident that the cold cabin is at 5°C. However
it is possible that the inside temperature is at 7°C. 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 5°C, the
highest and lowest readings should be 7°C & 4°C. (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
5°C. However the temperature goes regularly to 9°C and 3°C regularly.
This happened because the cooling unit is programmed accordingly. ie. It
has a high cut off at 4°C above the set point and low cut off of 2°C below
the set point. This can be programmed for 2°C for both high and low cut
off points. Thereafter the higher & lower cut off will be 7 & 3°C
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.
2. Reasons for failure of mapping study of a cold
room
General reasons for failure of a cold room are as under:
The display unit fixed at the outside of the cold room may not be
displaying the correct temperature of the cold room.
The loading and distribution of the shelves may not be uniform thus
hindering proper
airflow
Vacker LLC Hl PuOm Boidx i9t2y4 3m8 al Dyu bbaei lh UigAhEer than the permitted levels Part of VackerGlobal
Phone : (+971T) h4e 2 6p6o 1s1i t4i4o nli nFagx :o (f+ 9t7h1e) 4c 2o 6o6l ing units may notG rbouep iOnu rp oeffircfeesc :t U AloE c(Caotripo. nO ffitcheu),s In dia, Oman ,
11 55 Kuwait, USA
email:sales.uaaeff@evacctkienrggl o buanl.cifoomrm distribution w
Air curtains may be required at the doors w
w
.
3. Reasons for failure of mapping study of a Ware v
a
house c
k
e
r
g
l
o
b
a
l
.
c
o
m
For warehouses the most common reasons for failure are:
a. The number of cooling units or the capacity of the cooling units may not be
sufficient
b. The location of the ducts may not be proper
c. Humidity may be higher than desired levels
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. How to improve the results of the test and eliminate
chances of failure?
It is ideal that before carrying out the actual study, you may carry out a trial study
with few number of data loggers to analyze the data. This trial study will help you
to evaluate major problems if any. For all contracts being undertaken by us, we
carry out a trial study before commencement of the actual test. This will save
valuable time and money for the customer.
1. Advantages of a trial study
Major advantage of conducting a trial study are:
a. Saving time and money – After conducting a full test you may end up with
some deviations. In such case you will have to carry out a retest after
undertaking the corrective actions. By this time you may be in the
midst of a climate change and hence will have to wait for the next
season. If a trial study is planned properly, this can be avoided.
b. Correct settings for cooling units – sometimes just by changing the settings
of the cooling units you may have better results. You may not have noticed
this so far because your current recording devices were not placed at the
correct hot and cold points.
c. Requirement of dehumidifier – In many cases humidity distribution was
not properly
analyzed and hence may require installation of dehumidifiers. This is a
process involving time and money and hence if understood at the proper
Vacker LLC ls PtaOg Beox, 9s2u4i3t8a bl Dleu b ai cl tUioAnEs can be undertaken. Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
4.2. How to carry out a trial study?
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)
5. Documents related to Mapping study & Qualification
a. Case study of a temperature qualification study on a cold room
b. Protocol / SOP for Temperature qualification study of cold room
c. Protocol / SOP for Temperature mapping study of warehouse
NB: For ease of understanding, we generally mentioned about temperature
throughout the article. However all mentions about Temperature mapping study
are equally applicable for Temperature & Humidity mapping as well. Similarly all
mentions of a Temperature qualification study are equally applicable for
Temperature & Humidity qualification study.
Also temperature mapping study is known as Temperature distribution analysis.
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 Group Our offices : UAE (Corp. Office), India, Oman ,
11 55 Kuwait, USA
email:[email protected] w
w
w
.
v
a
c
k
e
r
g
l
o
b
a
l
.
c
o
m
Comments