Dispositivos de Monitoreo de Temperatura

WHO/EPI/LHIS/97.09 REV.

1
Original: English
Distribution: General

Equipment
performance specifications
and test procedures

E6: Temperature monitoring

devices
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GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION

EXPANDED PROGRAMME ON IMMUNIZATION
World Health Organization, Geneva, 1997
Date of last revision of this module: 1 January 1998

E6: Temperature monitoring devices
This module is part of the following series:
E1: Equipment performance specifications for cold rooms and freezer

rooms
E2: Equipment performance specifications for motorcycles
E3: Equipment performance specifications for refrigerators and freezers
E4 & E11: Equipment performance specifications for insulated containers
E5: Equipment performance specifications for icepacks
E6: Equipment performance specifications for temperature monitoring
devices
E7: Equipment performance specifications for cold chain accessories
E8: Equipment performance specifications for injection devices
E9: Equipment performance specifications for steam sterilizers
E10: Equipment performance specifications for injection accessories
Annexes
ii Equipment performance specifications and test procedures

Equipment Performance Specifications
Contents
Equipment Specification Applies to Page

reference test procedure
Equipment descriptions 1
7-Day Temperature Recorder, Fixed E6/TR.1 E6/PROC/1 3
7-Day Temperature Recorder, Portable E6/TR.2 E6/PROC/2 4
Electronic Thermometer, Portable E6/TH.1 E6/PROC/1 5
Gas or vapour pressure dial E6/TH.2 E6/PROC/1 6
thermometer, fixed
Alcohol or Bi-Metal thermometer, E6/TH.3 E6/PROC/2 7
portable
Bi-metal stem thermometer, fixed E6/TH.4 E6/PROC/1 8
Liquid crystal thermometer, portable E6/TH.5 E6/PROC/2 9
Temperature threshold indicator E6/IN.1 E6/PROC/3 10
Cold chain monitor E6/IN.2 E6/PROC/4 11
Freezewatch indicator, irreversible E6/IN.3 E6/PROC/3 12
Freezewatch indicator, reversible E6/IN.4 E6/PROC/3 13
Vaccine vial monitors (VVM) for OPV E6/IN.5 E6/PROC/5 14
Test Procedures
Equipment Procedure Applies to Page

reference specification
Test Conditions 18
Recorders and thermometers for Remote E6/TR1 E6/PROC/1 21
temperature reading (Recorders)
E6/TH1, 2, 4
(Thermom)
Recorders and thermometers where read- E6/TR2 E6/PROC/2 23
out unit and sensor have same (Recorders)
temperature E6/TH3
(Thermom)
Indicators monitoring temperature alone E6/IN1, 3, 4 E6/PROC/3 25
Indicators monitoring temperature & E6/IN2 E6/PROC/4 26

time
Vaccine vial monitors for polio vaccine E6/IN5 E6/PROC/5 28
This module contains references to the following annexes, printed separately in

WHO/EPI/LHIS/97.14:
Annex 1: Testing institutions
WHO/EPI/LHIS/97.09 iii
Equipment performance
specifications
Equipment descriptions
Performance specifications cover the following types of temperature monitoring device
required for the vaccine cold chain:
Temperature recorders:
E6/TR.1 7 day temperature recorder, fixed. To record the storage temperature
in cold rooms containing vaccine stocks.
E6/TR.2 7 day temperature recorder, portable. Used by supervisors or

technicians to check the performance of cold chain equipment.
Thermometers:
E6/TH.1 Electronic digital thermometer, portable. Used by supervisors or
technicians to check temperatures in vaccine stores.
E6/TH.2 Gas or vapour pressure dial thermometer, fixed. To monitor

temperatures in refrigerators or freezers in urban or district health
centres and vaccine stores.
E6/TH.3 Alcohol or bi-metal thermometer, portable. Used inside refrigerators

in small health centres; can also be packed with vaccine during
transport.
E6/TH.4 Bi-metal stem thermometer, fixed. Can be fitted to cold boxes or

smaller carriers.
E6/TH.5 Liquid crystal thermometer, portable. Used inside cold boxes and
vaccine carriers during transport.
Indicators:
E6/IN.1 Temperature threshold indicator. Monitors temperature of
consignments of DT, DTP or TT vaccine during international or
national transport.
E6/IN.2 Cold chain monitor. Monitors temperature and time in the vaccine
cold chain.
E6/IN.3 Freezewatch indicator, irreversible. Warns if adsorbed vaccine (DTP,

DT, TT, Hepatitis B) has been exposed to freezing.
WHO/EPI/LHIS/97.09 1
E6/IN.4 Freezewatch indicator, reversible. Indicates when it is safe to pack

icepacks together with DTP or TT vaccine for transport in insulated
containers.
E6/IN.5 Vaccine vial monitors. Serves primarily to warn health workers when
the cumulative heat exposure of a vial of vaccine has exceeded a
preset limit, beyond which the vaccine should not be used. In
addition: changes in the appearance of the VVM before this limit is
reached, will serve to guide health workers to use more exposed
vials of vaccine first .
2 Equipment performance specifications and test procedures

7 DAY TEMPERATURE RECORDER, FIXED

Specification reference: E6/TR.1
Applies to procedures: E6/PROC/1
Date of last revision: 1 January 1998
Power source:
7 day clockwork or rechargeable battery.
Temperature ranges & accuracy:

Upper limit: +50°C with over-range protection
Lower limit: -30°C with under-range protection.
Accuracy: ±1°C.
Maximum relative humidity:

90%.
Number of probes:
2
Length of leads:
15 metres.
Alarm contact specification:

Adjustable, break on rise and fall, 2 contacts.
Casing specification:
Non-corrodible, sealed mechanism.
Mounting specification:
Surface vertical mounting. To be supplied with screws and wall plugs.
Application and remarks:

To record the storage temperature in central and regional cold rooms containing
vaccine stocks.
7 DAY TEMPERATURE RECORDER, PORTABLE

Specification reference: E6/TR.2
Power source:
Clockwork or rechargeable battery.

Accuracy: ±1°C.

90%
Number of probes:
0 or 1
Non corrodible, sealed mechanism.
Robustness:
To withstand 5 drops from 1 metre and vibration test in carrying case.
Surface mounting or none.
Accessories:
Protective carrying case.

Used by supervisors and technicians for spot checks and to check the
performance of cold chain equipment.

ELECTRONIC THERMOMETER, PORTABLE

Specification reference: E6/TH.1
Power source:
Rechargeable or replaceable battery

Accuracy: ±0.5°C

90%
Number of probes:
1 or 2
Length of leads:
1 metre
Non-corrodible, sealed
Robustness:
To withstand 5 drops from 1 metre and vibration test in carrying case.
Accessories:
Protective carrying case.

Used by supervisors and technicians to make on-site temperature checks.
GAS or VAPOUR PRESSURE DIAL THERMOMETER,

FIXED
Power source:
Battery or none

Lower limit: -30°C with under-range protection
Accuracy: ±1°C

90%
Number of probes:
1
Length of leads:
1.5 metres
Alarm contact specification:

If it has alarm contacts, contacts must be adjustable to break on rise or fall of
temperature. If it has no alarm contacts, a maximum or minimum needle must
be fitted.
Non-corrodible, sealed mechanism, protected sensor leads.
Surface mounting; to be supplied with screws and wall plugs.

Used to monitor temperatures in refrigerators or freezers in urban or district
vaccine stores and health centres.

ALCOHOL OR BI-METAL THERMOMETER,

PORTABLE
Power source:
None

Upper limit: +50°C
Lower limit: -30°C
Accuracy: ±1°C
Scale markings:
Easily readable with a minimum space of 1 mm between each line:
Long lines (with numbers) for each 10 degrees
Short lines for even numbered degrees
Shorter lines for odd numbered degrees
Safe zones for ranges of 0°C to +8°C and -15°C to -25°C to be marked with a
green bar.

90%
Robustness:
To withstand 5 drops from 1 metre and vibration test.
Construction:
The glass column must be protected against breakage and strongly supported so
that:
• the column cannot be displaced more than 0.5 mm vertically with respect to
the scale;
• the reading angle is between 80/100° to plane of support plate.
Hook to suspend from shelf, or adhesive.
Used inside refrigerators or freezers in small health centres. Can also be packed
with vaccines during transport.
BI-METAL STEM THERMOMETER, FIXED

Power source:
None
Temperature range & accuracy:

Upper limit: +50°C, over-range protection
Lower limit: -30°C
Accuracy: ±1°C

90%
Number of probes:
1 stem
Length of stem:
Stem should be long enough to measure temperature as specified through 100
mm of insulation.
Non-corrodible, sealed mechanism, robust, 60 mm diameter face.
Surface mounting, projecting stem

Can be fitted to cold boxes or vaccine carriers during the transport of vaccine.
Model for cold chain supervisors to have smaller diameter and shorter stem with
a pen type pocket fixing .

LIQUID CRYSTAL THERMOMETER, PORTABLE

Power source:
None
Temperature range & accuracy:

Upper limit: +50°C
Lower limit: 0°C to 20°C
Accuracy: ±1°C
Scale markings:
Safe zones for ranges of 0°C to +8°C and -15°C to -25°C to be marked with a
green bar. Easily readable scale.

90%
Robustness:
To withstand 5 drops from 1 metre and vibration test.
Hook to suspend from shelf, or adhesive.

Used inside cold boxes and vaccine carriers during transport.
TEMPERATURE THRESHOLD INDICATOR

Specification reference: E6/IN.1
Temperature threshold:
48°C, irreversible colour change
Time/temperature function:
None
Features:
Colour spot change at threshold temperature.
Application:
Monitors temperature of consignments of DT, DTP or TT vaccine and warns of
excessive heat exposure during international or national transport.

COLD CHAIN MONITOR

Temperature thresholds:
+10°C, irreversible colour change
+34°C, irreversible colour change
+10°C portion: 14 days to full scale colour change at +12°C.
+34°C portion: 3 hours to full scale colour change at 37°C.
Colour change should not occur unless indicator is activated.
Features:
Progressive colour spread or colour change above threshold temperatures.
Indicator strip attached to a card on which instructions for use are printed, in
accordance with WHO format.
Application:
Monitors temperature of vaccine consignments and warns of excessive heat
exposure during international or national transport.
FREEZEWATCH INDICATOR, IRREVERSIBLE

Temperature threshold:
-5°C, irreversible colour change or
0°C, irreversible colour change
None.
Features:
Colour spot change at threshold temperature
Application:
Packed with adsorbed vaccines (DT, DTP, TT and Hepatitis) to warn of
exposure to temperatures below -6.5°C for the -5°C model and -1°C for the 0°C
model.

FREEZEWATCH INDICATOR, REVERSIBLE

Temperature thresholds:
-4°C, reversible colour change
None.
Features:
Colour spot change at threshold temperature
Application:
Attached to the surface of an icepack, the indicator shows when it is
safe to pack DT, DTP and TT vaccine with icepacks for transport in insulated
containers.
VACCINE VIAL MONITORS (VVM)

Specification reference : E6/IN5
Applies to test procedures : E6/PROC/5
Date of issue : 25 March 20021
Purpose
Vaccine vial monitors serve primarily to warn health workers when the
cumulative heat exposure of a vial of vaccine has exceeded a pre-set limit,
beyond which the vaccine should not be used. In addition, changes in the
appearance of the VVM before this limit is reached will serve to guide health
workers to first use more exposed vials of vaccine.
Format and dimensions
The VVM is a circle of colour, minimum diameter 7.0mm with a square of
colour, minimum dimensions 2.0 x 2.0mm positioned in the centre of the
circle (see Figure 1). The ratio of the area of the square to the area of the circle
(including the square) is at least 0.1, whatever dimensions are chosen.
Figure 1. Format and dimensions of VVM
SQUARE CIRCLE
minimum minimum
2.0mm 7.0mm
Design
The circle of the VVM acts as a static, reference colour and the square is a
changing, active colour change device. The colour change is limited to a
change of shade, from light to dark. Any colour is permitted for the VVM
design, but changes in hue are not permitted.
Colour
The colour density change of the indicator is illustrated in the Figure 2 below.
At the start point the colour of the square is lighter than the circle. The end
point is indicated when the colour of the square matches the circle. The end
point is exceeded when the colour of the square is darker than the circle. The
following paragraphs describe the colour change in more detail.
1
Replaces the previous version of 13 August 1999.

Figure 2. The colour density change of the indicator

(the central square is the active surface)
· Start point · Square lighter than circle
· End point · Square matches the circle
· End point exceeded · Square darker than the circle
Definition of the start-point

The colour of the active surface of the VVM at the time of labelling of the
vaccine vial is called the "start point".
At the start point, the colour density of the square as measured by a colour
densitometer,2 must be lighter than the colour shade of the circle by a
difference of at least 0.25 OD densitometer units.
Definition of the end-point
The colour of the active surface of the VVM at the limit of use of the vaccine
vial is called the "end point".
The end point is reached when the difference in the average colour density
obtained from readings at least two different points on the circle and the
colour density of the square is 0.00 OD, as measured by the densitometer.
The end point is exceeded when the colour of the square is darker than the
colour of the circle.
Homogeneity of the reference colour
The colour density of one 2mm diameter portion of the circle must be within
0.01 OD of the colour density at any other two 2mm diameter portions of the
circle, when measured with a colour densitometer.
VVM reaction rates
Reaction rates are specific to four different models of VVM, relating to four
groups of vaccines according to their heat stability at two specific
temperature points (see Table 1).
2
Colour reflection densitometer Xrite Model 404 GS or GSX
Table 1: VVM reaction rates by category of heat stability
Category: No. days to end No. days to Time to end

(Vaccines) point at +37°C end point at point at +5°C
+25°C
VVM30
30 193 > 4 years
HIGH STABILITY
VVM14
14 90 > 3 years
MEDIUM STABILITY
VVM7
7 45 > 2 years
MODERATE STABILITY
VVM2
2 NA* 225 days
LEAST STABLE
*VVM (Arrhenius) reaction rates determined at two temperature points
At +37°C, RH 33% +/-5% and RH 75% +/-5%, at least 90% of VVMs tested
should reach the end point within a range of time whose upper limit is
shown in Table 1 or a period set by the vaccine manufacturer, based on
published vaccine stability data, and whose lower limit is 25% below the
upper limit (see Figure 3).
At +25°C (ambient humidity in submerged plastic/foil pouch) at least 90% of

VVMs tested should reach the end point within a range of time whose upper
limit is shown in Table 1 for VVM30, VVM14 and VVM7 categories, or a
period set by the vaccine manufacturer, based on published vaccine stability
data, and whose lower limit is 40% below the upper limit (see Figure 3).
At 5°C (ambient humidity in submerged plastic/foil pouch), all VVM30,

VVM14, and VVM7 samples should reach the end point after the lower time
limit specified in Table 1. Conformance can be determined by extrapolation
from high temperature (25 and 37°C) data. At 5°C (ambient humidity in
submerged plastic/foil pouch), at least 90% of VVM2 samples tested should
reach the end point within a range of time whose upper limit is 225 days and
whose lower limit is 40% below the upper limit (see Figure 3).
A tolerance is allowed in the above tests for up to 5% of VVM samples tested

to reach the end point after the upper limit and 5% before the lower limit (see
Figure 3).
The colour change shall be monotonic in its response to cumulative heat

exposure within the limits of the allowed variation. The observer shall be
able to distinguish between unchanged, 50% and the end point of the
indicator.

Figure 3. Stability limit criteria by sample group
Stability time limit set in Table 1

or manufacturer’s data
20.0% 20.0% at +25°C & 5°C

12.5% 12.5% at +37°C
Samples 5% 90% 5%
Time
Global measurement accuracy

The allowable total error for measuring the difference between the colours of
the circle and square is ± 0.04 OD when using an X-Rite 404 GS(X) colour
reflectance densitometer. Major sources of error are instrument error for both
the circle and square, repeatability, and variation in end point caused by an
allowed temperature variation of ± 0.2°C.
Water bath precision and control
The VVMs should be tested in water baths controlled to within ± 0.2°C. (Any
additional 0.1°C variation in temperature control requires an allowance for
additional measurement error.)
Reversion
The indicator shall not revert to a lighter colour at any point in its life when
exposed to conditions likely to be found during normal use. After the
endpoint is reached, the square shall remain the same colour as the circle or
become darker than the circle.
Integrity of VVMs
The integrity of VVMs depends on the presentation of the vaccine:
For liquid vaccines:

The VVM shall be permanently attached to the vaccine vial, even after the
vial has been opened and remain readily observable before, after and
during use. Prior to opening, the VVM should not be removable: it should
resist removal from the vaccine vial as much as a label meeting current
requirements.
For freeze-dried vaccines:

The VVM shall be attached to the vaccine vial or ampoule, remaining
readily observable until the vial or ampoule is opened but not observable
after opening. Prior to opening, the VVM should not be removable: it
should resist removal from the vaccine vial as much as a label meeting
current requirements.
The performance of the VVM should not be changed by soaking in water for
8 hours. They should conform to within +/-0.04 OD units.
Safety
The exposed surface of the VVM shall not be able to endanger human health.
The materials of the VVM shall be non-toxic and non-irritant. The VVM
should meet any requirements in force concerning toxicity of labels or
packaging in the country of manufacture.

Test Procedures
Standard test procedures
General test conditions
1. Introduction
Equipment used for monitoring vaccine storage in the cold chain falls into ten
categories:
Category Procedure Ref

Specification
Seven day temperature recorders (fixed) E6/TR/1 E6/PROC/1

Seven day temperature recorders (portable) E6/TR/2 E6/PROC/2
Electronic thermometers (portable) E6/TH/1 E6/PROC/1
Dial thermometers (fixed) E6/TH/2 E6/PROC/1
Alcohol, bimetal and other simple therm. E6/TH/3 E6/PROC/2
(portable)
Bi-metal stem thermometers (portable or E6/TH/4 E6/PROC/1
fixed)
Temperature threshold indicator E6/IN/1 E6/PROC/3
Cold chain monitor E6/IN/2 E6/PROC/4
Freezewatch indicator, irreversible E6/IN/3 E6/PROC/3
Freezewatch indicator, reversible E6/IN/4 E6/PROC/3
Vaccine Vial Monitor E6/IN/5 E6/PROC/5
TST indicator E6/IN/6 E6/PROC/6
2. Inspection
On receipt, all monitoring instruments should be checked for similarities
between different brands, dissimilarities between samples of one brand, and any
defects or damage. Also describe any differences between the instrument
ordered and that received. Code each brand and tabulate the following
information where relevant:
Identification:
· code,
· brand/model,
· manufacturer/distributor,
· type of thermometer (e.g. mercury in glass, mercury in steel with remote
sensor, bimetallic coil, indicating/recording etc.), and category as described
above:
· country of origin.
Temperature range and scale:

· indicated working range,
· scale/dial markings,
· scale colour,
· any safe/range marking,
· assessment of legibility.
Materials and construction:

· materials of all major external components,
· major rectangular dimensions (±l mm),
· maximum distance of any remote sensor unit,
· weight (± l g),
· special features (where relevant),
· presence of airtight seal against dust and moisture,
· power source,
· presence of maximum/minimum temperature indicators,
· maximum recording time,
· number of alarm contacts,
· method of fixing.
A black and white, three quarter view photograph should be taken of the sample.
The presence of instructions and the languages in which they are printed should
be reported.
3. Activation
Monitoring instruments which require mechanical activation or other
preparation before they are used should be prepared precisely to the
manufacturer's instructions before they enter any tests which require them to be
active.
4. Effect of high humidity

It is expected that humidity variation will not normally affect the calibration of a
thermometer, but it may cause internal condensation which will result in
corrosion and hence jamming of internal components over a longer time period
for the following thermometer types:
20 Equipment specifications and test procedures

Test Procedures
· clockwork recorders;
· vapour pressure thermometers;
· bi-metal thermometers.
It is difficult to simulate this in an accelerated test, and the best that can be done
is to see whether the sealing of the thermometers is sufficient to prevent
problems of this nature from occurring.
Place one sample of the thermometer in an ambient temperature of +43°C, 90%
RH, and leave to stabilize for 3 hours. Remove the thermometer and place in cold
water. Examine the thermometer for evidence of water ingress.
For those thermometers which, from the above test are not fully sealed, carry out
an additional test as follows. Place the thermometer mechanism, removed from
its case if possible, into a 2% saline solution, and allow to dry for 3 hours. Repeat
this operation twice a day for 5 days and then examine for signs of corrosion.
Indicate the extent of any deterioration by photographs and reporting.
5. Combined indicators
If an indicator consists of a combination of various independently functioning
indicators, it should undergo all tests relative to each individual indicator. It can
only qualify if it passes all tests.
RECORDERS AND THERMOMETERS FOR REMOTE

TEMPERATURE READING
Procedure reference: E6/PROC/1
Applies to specification: E6/TR1 (Temperature recorder)
E6/TH1, 2, 4 (Thermometers)
1. Calibration and measurement accuracy
Test condition:
to +25°C ambient temperature in the area of the read-out units;
the sensors at calibration test temperature.
Procedure:
One sample of each thermometer or recorder should be tested. Mount the sensors
on one side of a 100 mm insulated partitioning where the temperature can be
controlled between +10°C and -10°C with an accuracy of ±0.5°C. The reading unit
should be placed on the other side where the temperature can be controlled
between +20°C and +50°C with an accuracy of ±1°C.
Position each sensor close to a standard reference thermometer and when the
indicated temperatures on both are stable, record the reading given by each.
Calibrations should be carried out at 3 temperatures:
· +10°C
· 0°C,
· -10°C.
Present the data showing the measurement error in °C against the reference
temperature.
Test criteria for qualification:

Specification
· E6/TR1 Reading accuracy ±1.0°C.)
· E6/TH1 Reading accuracy ±0.5°C,
· E6/TH2,TH4 Reading accuracy ±1.0°C.
2. Variation of performance with ambient temperature
Test condition:
· +43°C local temperature in the area of the read-out units;
· 0°C ambient temperature at the sensors.
Procedure:
While the temperature on the sensor side is maintained at 0°C, the temperature
on the reading side is raised to +43°C. Observe any change in the reading of the
sensor temperature when compared with that of a reference thermometer which
is placed as close to the sensor as.

Test Procedures

· E6/TH1 Less than 0.5°C difference.
· E6/TR1,TH2,TH4 Less than 1°C difference.
3. Exposure to over-range temperatures
Test condition:
-30°C and +50°C.
Procedure:
Examine the construction of each sample of monitoring equipment and, if this
suggests the risk of damage outside the nominal working range, test to find what
actually happens if the ambient temperature exceeds this range by up to a
maximum of 20°C. (Do not test outside the range -30°C to +50°C). Record all
instances of distortion, change of calibration, or permanent damage.
Test criteria for qualification (Specifications E6/TR1, TH1,2,4):

No damage.

Let the thermometer undergo the humidity test as described in General Test
Conditions E6, procedure 4.
Test criteria for qualification (Specifications E6/TR1,TH1,2,4):

No water entry into instrument.
5.Resistance to vibration/dropping
Test condition:
+20 to +25°C ambient temperature.
Procedure:
Perform a drop test on one sample of Category E6/TH1 thermometer. Drop 5
times from a height of l metre onto a hard floor, and from different angles.
Category E6/TH1 instruments should be in their cases, if available. Record
damage occurring at each drop.
Mount each Category E6/TH1 instrument on a programmable vibrating table.
Vibrate for 30 minutes at an amplitude of l0 mm, (20 mm peak-to-peak), with the
frequency varying between 2 Hz and l0 Hz at a rate of change (up and down) of l
octave/minute. Check for visible damage and any obvious loss of calibration.
Test criteria for qualification (Specification E6/TH1):

No damage recorded which affects the performance of the instrument.
RECORDERS AND THERMOMETERS WHERE

READ-OUT UNIT AND SENSOR HAVE SAME
TEMPERATURE
Applies to specification: E6/TR2 (Temperature recorders)
E6/TH3 (Thermometers)
1. Calibration and measurement accuracy
Test condition:
Calibration test temperature.
Procedure:
One sample of each thermometer or recorder should be tested. Place the
thermometer where the temperature can be controlled between +10°C and -10°C
with an accuracy of ±0.5°C.
Position each sensor close to a standard reference thermometer and when the
indicated temperatures on both are stable, record the reading given by each.
Calibrations should be carried out at 3 temperatures: +10°C, 0°C and -10°C.
Present the data showing the measurement error in °C against the reference
temperature.

Reading accuracy ±1°C.
2. Exposure to over-range temperatures
Test condition:
-30°C and +50°C.
Procedure:
Examine the construction of each sample of monitoring equipment and, if this
suggests the risk of damage outside the nominal working range, test to find what
actually happens if the ambient temperature exceeds this range by up to a
maximum of +20°C (do not test outside the range -30°C to +50°C). Record all
instances of distortion, change of calibration, or permanent damage.

No damage.

Let the thermometer undergo the humidity test as described in General Test
Conditions E6, procedure 4.

Test Procedures

No water entry into instrument.
4. Resistance to vibration/dropping
Test condition:
· +20 to +25°C ambient temperature.
· Sample in carrying case or packaging, if provided.
Procedure:
Perform a drop test on one sample of Categories TR2 & TH3 thermometers.
Drop 5 times from a height of l meter onto a hard floor, and from different
angles. Record damage occurring at each drop.
Mount each Categories TR2 and TH3 instruments on a programmable vibrating
table. Vibrate for 30 minutes at an amplitude of l0 mm, (20 mm peak-to-peak),
with the frequency varying between 2 Hz and l0 Hz at a rate of change (up and
down) of l octave/minute. Check for visible damage and any obvious loss of
calibration.

No damage recorded which affects the performance of the instrument.
INDICATORS MONITORING TEMPERATURE ALONE

Applies to specification E6/IN1, 3, 4
1. Efficacy of mechanical activation
Test condition:
+43°C ambient temperature, 90% RH.
Procedure:
Indicators which require mechanical activation are exposed to the above ambient
condition for a period of 48 hours, then examined for changes in state without
mechanical activation having taken place.
Test criteria for qualification (Specifications E6/IN1,3,4):

No change in state to be observed.
2. Accuracy of threshold temperature
Test condition:
3°C over/under activation temperature.
Procedure:
20 samples of active indicators to be exposed to a temperature 3°C ±0.5°C on the
safe side away from the threshold temperature for a period of five hours. Then
the temperature is in or decreased by 0.5°C increments each hour closer to the
threshold temperature and up to four 0.5°C increments past the threshold
temperature. (Or until all indicators have begun to change; whichever is the
sooner). The condition of all indicators to be recorded by photography each hour
of the test.
Test criteria for qualification (Specification E6/IN1,3,4):

Colour change to begin in 100% of samples within 1.5°C of the nominal threshold
temperature in the time specified by the manufacturer.
3. Reversibility of indicators
Test condition:
Temperature required for reversal.
Procedure:
20 samples of the reversible indicators are exposed to the temperature and time
at which the manufacturer claims reversal to take place. The condition of all
indicators is then inspected and noted.
Test criteria for qualification (Specification E6/IN4):

Reversal to take place in 100% of samples.

Test Procedures
INDICATORS MONITORING TEMPERATURE AND

TIME
Applies to specification E6/IN2
1. Efficacy of mechanical activation
Test condition:
+43°C ambient temperature, 90% RH.
Procedure:
Indicators which require mechanical activation are exposed to the above ambient
condition for a period of 48 hours, then examined for changes in state without
mechanical activation having taken place.

No change in state to be observed.
2. Accuracy of threshold temperature

(D section = 34°C threshold temperature)
Test condition:
3°C under threshold temperature.
Procedure:
20 indicators are stabilized for a period of 2 hours at a temperature of 3°C ±0.5°C
below the threshold temperature without being activated. The samples are then
activated and are exposed to the same temperature for a period of five hours.
Then the temperature is increased by 0.5°C increments each hour closer to the
threshold temperature and up to four 0.5°C increments past the threshold
temperature. (Or until all indicators have begun to change; whichever is the
sooner). The condition of all indicators to be recorded by photography each hour
of the test.

Colour change to begin in 100% of samples within 1.5°C of the nominal threshold
temperature in the time specified by the manufacturer.
3. Temperature and time tests
Test condition:
(1) Stop test.
(2) +12°C ambient temperature.
For each of the following 5 tests samples of 20 indicators should be used:

(1) Stop test: 20 activated monitors are exposed to a temperature of +8°C
for 5 days. If any changes occur the test can be terminated .
Temperature is now raised to +37°C for 8 hours. The colour change is recorded
by photography. Temperature is now decreased to +8°C. After 1 hour and again
after 7 hours the colour changes are recorded by a photograph. Temperature is
now again raised to +37°C for 8 hours. The colour change is recorded by a
photograph.
The procedure is repeated until all windows have changed colour.
(2) 12°C ambient temperature: 20 activated monitors are exposed to a
temperature of +12°C. Times until all monitors have changed colour in
window A, B and C are recorded by photography each 8 hours of the test.
(3) 21°C ambient temperature: 20 activated monitors are exposed to a
?4?? 37°C ambient temperature: 20 activated monitors are exposed to a
?5?? 37°C ambient temperature: 20 activated monitors are exposed to a

window D are recorded by photography each hour of the test.

(1) The stop length shall be less than 1/4 of a window, and a complete stop
shall occur less than 1 hour after the monitors have been returned to 8°C.
After returning to +37°C the monitor shall be active again.
(2) 3 days, all change colour in A.
8 days, all change colour in A+B.
14 days, all change colour in A+B+C.
(3) 2 days, all change colour in A.

6 days, all change colour in A+B.
11 days, all change colour in A+B+C.
?4?? No criteria set.
?5?? 3 hours, all change colour in D.

Test Procedures
VACCINE VIAL MONITORS FOR ALL VACCINES

Applies to specification: E6/IN5
1
Date of issue: 25 March 2002
Test conditions:
§ The temperature of the water bath and the temperature and relative humidity
of the test chamber should be monitored throughout the test and a summary
of the data included in the final report. The temperature stability and
uniformity should be controlled within a tolerance of ±0.2°C and the relative
humidity should be controlled within a tolerance of ±5% RH.
§ Five hundred VVMs and 6 test patches of the active material2 for each VVM
reaction rate category to be tested should be delivered to the laboratory
already in an active state. They should be packed in an insulated container with
dry ice and there should be residual dry ice on arrival at the laboratory. The
VVMs and test patches should be labeled with individual identification
numbers and reaction rate category (2, 7, 14 or 30).
§ The VVMs and test patches should be stored below -20°C in a freezer whose
temperature is recorded continuously. Testing should commence within two
weeks of the arrival of the samples at the laboratory.
§ When the samples are handled in preparation for the tests they should be
removed from freezing, individually for the briefest period possible before
being returned again to storage below -20°C.
§ Humidity in the test chamber should be controlled accurately with salt
solutions, e.g. 33% RH – 370 g of Magnesium Chloride hexahydrate per 100 g of
deionized water and 75% RH – 45 g of Sodium Chloride per 100 g of deionized
water.
§ Colour measurements will be made with a Spectraflash SF600
Spectrophotometer or equivalent and a colour reflection densitometer Xrite
Model 404 GS or GSX or equivalent with the visual colour filter or as agreed
with the manufacturers of the VVMs.
§ Reaction rates are specific to four different categories of VVM, relating to four
groups of vaccines according to their heat stability at two specific temperature
points (see Table 1).
1 Replaces the previous version of 1 January 1998
2 These test "patches" of the active material should be at least 7 mm diameter printed on the same backing
paper as the VVM, but without the printed reference colour
Table 1: VVM reaction rates by category of heat stability

and temperature and time periods for testing
Category: No. days to end No. days to end Time to end

o o
(Vaccines) point at +37 C point at +25 C point at +5°C
VVM30 30 193 > 4 years
HIGH STABILITY
VVM14 14 90 > 3 years
MEDIUM STABILITY
VVM7 7 45 > 2 years
MODERATE STABILITY
VVM2 2 NA* 225 days
LEAST STABLE
*VVM (Arrhenius) reaction rates determined at 5 and 37 degrees C
Unless otherwise specified, the two temperatures and time periods highlighted in
Table 1 will be the agreed test period for testing each VVM category.
Additionally, each VVM category will be tested at a time greater than the end
point time to verify that all VVM samples will reach the end point.
1. Characterizing the colour change

The specification calls for a shade change without a hue change. It is therefore
necessary to study the colour change using both a densitometer and a
spectrophotometer to ensure that the extent of hue change is small enough not to
significantly affect the validity of colour densitometer readings, which are used
for the remainder of the tests.
Three test patches (for each VVM category to be tested) should be incubated at
+37°C ±0.2°C inside sealed pouches (5-mil heat sealable polyester bags
measuring 6” x 8”) in a water bath and readings taken at time zero, and at the
same time each day until the end-point is reached. Each reading should consist of
one measurement taken at room temperature in the shortest possible time with
the spectrophotometer and one measurement taken with the colour densitometer
for each of the three samples, positioning the instrument heads at the centre of
the test patch. The densitometer should be calibrated every day it is used, and the
spectrophotometer should be calibrated according to the manufacturer's
recommendations.
The densitometer readings should be tabulated alongside the spectrophotometer
readings. The difference in L value between the start point and that measured on
each day of the test should be plotted against the corresponding change in optical
density. If these data do not correlate, then the results should be discussed with
WHO before proceeding with the remaining tests.

Test Procedures
2. Format and dimensions

The dimensions of the VVMs should be checked against the limits of the
specification. A random sample of 20 VVMs (for each VVM category to be tested)
should be used to check the ratio of the square area to the reference circle area.
When the samples are handled for measurement, they should be removed from
freezing, individually for the briefest period possible before being returned again
to storage below -20°C.
3. Recording the starting point

The same portion of the active surface on all VVM samples should be read, using a
colour densitometer and recorded. Three different portions of the reference surface
should also be read on 5 samples, recorded and the average reading calculated for
each sample. If the following conditions are not met, the test should be halted, the
readings should be tabulated and the manufacturer should be contacted for a new
batch of sample VVMs.
§ The active surface readings for all samples should be within ±0.03 OD of the
mean of the whole group.
§ The difference between the readings of the active surface and the reference
surface should conform to the specification for the start point when five
samples are selected at random.
§ The three readings taken from the reference circle on five samples should
conform to the specification for homogeneity.
If these conditions are met, the samples should be divided into four sets (I, II, III,
and IV) of 60 samples each for reaction rate tests described in Sections 4 through
8. The remainder of the samples will be used as described in Sections 10 through
11. All samples must be stored below -20°C until testing begins.
4. VVM reaction rate; +37oC, no light, Test 1 (for all VVM categories)
Sample set "I" (60 samples) should be exposed to 37°C ±0.2°C inside sealed
pouches in a water bath. After 75% of the agreed test period in the water bath
without light, the first portion (20 VVMs) of sample set "I" should be removed
from the bath. The active surface on all 20 VVM samples should be read, using a
colour densitometer and recorded.
The second portion (20 VVMs) of the sample set should be removed from the
bath after 100% of the agreed test period. The active surface on all 20 VVM
samples should be read, using a colour densitometer and recorded.
The third portion (20 VVMs) of the sample set should be removed from the bath
after 125% of the agreed test period. The active surface on all 20 VVM samples
should be read, using a colour densitometer and recorded.
For checking purposes: After testing, samples for set "I" should continue to be
stored at +37°C for an additional 30 days. The active surface of the samples
should then be re-read with the colour densitometer and the readings compared
with those taken at the end of the first test.
5. VVM reaction rate; +37oC, 75% RH, no light, Test 2 (for all VVM
categories)
Sample set "II" (60 samples) should be exposed to 37°C ±0.2°C in a temperature-
controlled cabinet without light and with a relative humidity of 75 % ±5%. After
75% of the agreed test period in the cabinet, the first portion (20 VVMs) of sample
set "II" should be removed from the cabinet. The active surface on all 20 VVM
The second portion (20 VVMs) should be removed from the cabinet after 100% of
the agreed test period. The active surface on all 20 VVM samples should be read,
using a colour densitometer and recorded.
The third portion (20 VVMs) should be removed from the cabinet after 125% of
the agreed test period. The active surface on all 20 VVM samples should be read,
using a colour densitometer and recorded.
6. VVM reaction rate; +37oC, 33% RH, no light, Test 3 (for all VVM
categories)
Sample set "III" (60 samples) should be exposed to 37°C ± 0.2°C in a temperature-
controlled cabinet without light. After 75% of the agreed test period in the
cabinet without light and with a relative humidity of 33 % ±5% the first portion
(20 VVM) of the sample set "III" should be removed from the cabinet. The active
surface on all 20 VVM samples should be read, using a colour densitometer and
recorded.
cabinet after 100% of the agreed test period. The active surface on all 20 VVM
The third portion (20 VVMs) of the sample set should be removed from the
cabinet after 125% of the agreed test period. The active surface on all 20 VVM
samples should be read, using a colour densitometer and recorded. These
samples should then be moved to 5°C storage (see Reversion Test, Section 9).
7. VVM reaction rate; +25C, no light, Test 4 (for VVM30, VVM14 and
VVM7 categories)
Sample set "IV" (60 samples) should be exposed to 25°C ±0.2°C inside sealed
pouches in a water bath. After 60% of the agreed test period in the water bath,
the first portion (20 VVMs) of sample set "IV" should be removed from the water
bath. The active surface on all 20 VVM samples should be read, using a colour
densitometer and recorded.

Test Procedures
water bath after 100% of the agreed test period. The active surface on all 20 VVM
The third portion (20 VVMs) of the sample set should be removed from the water
8. VVM reaction rate; +5 oC, no light, Test 5 (for VVM2 only)

Sample set "IV" (60 samples) should be exposed to 5°C ±0.2°C inside sealed
pouches in a water bath. After 60% of the agreed test period in the water bath,
the first portion (20 VVMs) of sample set "IV" should be removed from the water
bath. The active surface on all 20 VVM samples should be read, using a colour
densitometer and recorded.
The third portion (20 VVMs) of the sample set should be removed from the water
9. Reversion test (for all VVM categories)

After testing, the third portion of 20 samples from set "III" should be stored at
+5°C for 30 days. The active surface of the samples should be re-read with a
colour densitometer and the readings compared with those taken at the end of
the first test.
10. Soak test (for all VVM categories)

Two groups of 10 VVM labels should be adhered to water impermeable
substrates (e.g., white plastic picnic plates). The first group should be submerged
in water at 5°C for 8 hours. The second (dry) group of labels should be sealed in
waterproof pouches and subjected to the same temperature treatment. At the end
of the 8-hour period, the labels should be removed from the water and the
soaked labels should be carefully dried with absorbent towels. Both groups
should then be placed in a desiccant chamber at 5°C for 16 hours. Next, both
groups of samples should be placed in waterproof pouches and in a 37°C water
bath. Once a day the labels should be removed from the water bath and the
active portion of each VVM measured until they reach end-point. The results of
the soaked versus dry OD measurements should be compared for conformity to
the specification (less than a 0.04 OD unit difference).
11. Observer perception test (for all VVM categories)

Fifteen VVM samples should be attached to empty 2 ml vials. 5 of the VVM
samples should be at the start point, 5 conditioned to 50% of the colour change to
end point and 5 at end point. The samples should be placed in a box in a random
order and stored in a freezer below -20°C to prevent further colour change.
Five observers should independently sort the vaccine vials into three groups
(unchanged, 50% changed, and end point). The observers should work in a poor
level of indirect natural light. The level of the light used should be recorded.
Reporting
A final report should be issued after all testing is complete. The report of the tests
should contain the following data and analyses:
§ water bath and test chamber temperature and humidity record
§ characterization of the colour change – table of readings and plot of L vs. OD
§ dimensional tolerances of the VVM
§ distribution of active surface starting point readings – maximum, minimum
and mean
§ distribution of the difference between the active surface and the reference
colour starting point readings – maximum, minimum and mean
§ homogeneity readings from the reference colour – table of readings
§ distribution of reaction test readings at all temperatures and times – per cent
reaching the end point
§ reversion test
§ soak test
§ observer perception test

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WHO/EPI/LHIS/97.09 REV.

E6: Temperature monitoring

To navigate, display “bookmarks”

GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION

World Health Organization, Geneva, 1997

Date of last revision of this module: 1 January 1998

This module is part of the following series:

E1: Equipment performance specifications for cold rooms and freezer

ii Equipment performance specifications and test procedures

Equipment Specification Applies to Page

Equipment Procedure Applies to Page

Indicators monitoring temperature & E6/IN2 E6/PROC/4 26

This module contains references to the following annexes, printed separately in

E6/TR.2 7 day temperature recorder, portable. Used by supervisors or

E6/TH.2 Gas or vapour pressure dial thermometer, fixed. To monitor

E6/TH.3 Alcohol or bi-metal thermometer, portable. Used inside refrigerators

E6/TH.4 Bi-metal stem thermometer, fixed. Can be fitted to cold boxes or

E6/IN.3 Freezewatch indicator, irreversible. Warns if adsorbed vaccine (DTP,

E6/IN.4 Freezewatch indicator, reversible. Indicates when it is safe to pack

2 Equipment performance specifications and test procedures

7 DAY TEMPERATURE RECORDER, FIXED

Temperature ranges & accuracy:

Maximum relative humidity:

Alarm contact specification:

Application and remarks:

7 DAY TEMPERATURE RECORDER, PORTABLE

Temperature ranges & accuracy:

Maximum relative humidity:

Application and remarks:

4 Equipment performance specifications and test procedures

ELECTRONIC THERMOMETER, PORTABLE

Temperature ranges & accuracy:

Maximum relative humidity:

Application and remarks:

GAS or VAPOUR PRESSURE DIAL THERMOMETER,

Temperature ranges & accuracy:

Maximum relative humidity:

Alarm contact specification:

Application and remarks:

6 Equipment performance specifications and test procedures

ALCOHOL OR BI-METAL THERMOMETER,

Temperature ranges & accuracy:

Maximum relative humidity:

BI-METAL STEM THERMOMETER, FIXED

Temperature range & accuracy:

Maximum relative humidity:

Application and remarks:

8 Equipment performance specifications and test procedures

LIQUID CRYSTAL THERMOMETER, PORTABLE

Temperature range & accuracy:

Maximum relative humidity:

Application and remarks:

TEMPERATURE THRESHOLD INDICATOR

10 Equipment performance specifications and test procedures

COLD CHAIN MONITOR

FREEZEWATCH INDICATOR, IRREVERSIBLE

12 Equipment performance specifications and test procedures

FREEZEWATCH INDICATOR, REVERSIBLE

VACCINE VIAL MONITORS (VVM)