Vaccines, Cold Chain and Logistics Management: Manual of Operations
Vaccines, Cold Chain and Logistics Management: Manual of Operations
Vaccines, Cold Chain and Logistics Management: Manual of Operations
VACCINES, COLD
CHAIN AND LOGISTICS
MANAGEMENT
Manual of Operations
5TH EDITION
2018
MANILA, PHILIPPINES
Table of Contents
Table of Contents 3
List of Figures 5
List of Tables 6
List of Annexes 7
Foreword 8
Acknowledgements 9
Introduction 3
Chapter 4. Receiving Vaccines and Safe Injection Equipment 69
Chapter 6. Distribution and Transport of Vaccines and Safe Injection Equipment 113
7.1 Preventive Maintenance Guide for Cold and Freezer Rooms 126
7.2 Recommended Actions if Storage Temperatures are Out of Range 132
7.3 Defrosting Vaccine Refrigerators 133
7.4 General Care of Cold Chain Equipment 134
Introduction 5
List of Tables
Number Title
Introduction 7
Foreword
The country has protected many infants and children against vaccine-preventable
diseases either through the routine or mass immunization campaigns nationwide. Service
providers need to be responsive as the immunization program expands to cover other age
groups coupled with the introduction of new vaccines. Vaccine-preventable diseases affect
not only newborns, infants, children and pregnant women but also compromise the health
and welfare of other vulnerable groups like adolescents and the elderly.
An adequate and readily available supply of vaccines in health facilities is critical to the
delivery of immunization services. The protective potentials of vaccines cannot be realized
without the availability of potent vaccines and their proper storage and management.
The Department of Health would like to acknowledge the support of the World Health
Organization (WHO) and the United Nations Children’s Fund (UNICEF) in the development
of this Vaccines, Cold Chain & Logistics Management Manual of Operation.
Introduction 9
Technical Terms and Acronyms
ADS Auto-Disabled syringe
AVR Automatic Voltage Regulator
AEFI Adverse Events Following Immunization
BCG Bacillus Calmette Guerin
BHS Barangay Health Station
BOC Bureau of Customs
bOPV Bivalent Oral Polio Vaccine
°C Celsius
Cm Centimeter
cm³ Cubic centimeter
CTC Controlled Temperature Chain
DOH Department of Health
DOH CO Department of Health Central Office
DOH RO Department of Health Regional Office
DTP-HepB-Hib Diphtheria, Pertussis, Tetanus-Hepatitis B-Haemophilus influenzae type b
DTRs Daily Temperature Recorders
EPI Expanded Program on Immunization
EVM Effective Vaccine Management
FDA Food and Drug Administration
FEFO First Expiry First Out
FIC Fully Immunized Child
HEPb Hepatitis B
HPV Human Papilloma Virus
IPV Inactivated Polio Vaccine
JE Japanese Encephalitis
LGU Local Government Unit
LMD Logistics Management Division
m³ Cubic meter
MCV Measles-Containing Vaccine
MDVP Multi-Dose Vial Policy
MMR Measles Mumps Rubella
MR Measles Rubella
NIP National Immunization Program
NIST US National Institute of Standards and Technology
PCM Phase Change Material
PCV Pneumococcal Conjugate Vaccine
Introduction 11
Introduction
Introduction 13
Chapter 1
THE PHILIPPINES’
COLD CHAIN SYSTEM
CHAPTER 1
The Philippines’ Cold Chain System
At the end of this chapter, the health worker will be able to:
A complete cold chain system is illustrated in Figure 1. The series of arrows at the bottom
of the figure show the flow of vaccines down to the health facilities; the series at the
top show where data are collected, recorded, checked and analyzed and how reporting
information flows back up the chain. Following this sequence ensures that cold chain
performance is properly monitored and the necessary information is gathered to aid
vaccine forecasting.
In the Philippines, vaccines and immunization supplies are stored and managed at
different locations. It is therefore important to plan and coordinate the delivery of vaccines
and other immunization supplies to ensure that all health centers and other service
delivery points are provided with adequate vaccines; correct diluents; and adequate
syringes, droppers, and safety boxes.
FIGURE 1.
The cold chain system
Manufacturer
Request for
supply
Annual statistics
and estimates
Analysis Airport/
Seaport
Monthly report/
checking Central store
Daily
record
Subnational store
Health centre
Vaccinator/
mother and child
Depending on the capacity required, cold or freezer rooms, refrigerators, cold boxes, and in
some cases, refrigerated trucks for transportation are used at the primary level.
Depending on the capacity required, the secondary level generally uses equipment similar
to the primary level, such as cold or freezer rooms, refrigerators, cold boxes, and in some
cases, refrigerated trucks for transportation.
Depending on the capacity required, cold or freezer rooms and/or freezers, refrigerators,
cold boxes, and in some cases, refrigerated trucks for transportation are used at this level.
Depending on the capacity required, refrigerators (in certain cases, with water pack
freezing/cooling compartment), cold boxes and vaccine carriers are needed at this level.
• Develop policies, guidelines and tools relevant to cold chain and logistics
management
• Develop an evidence-based national plan and strategy to strengthen the country’s
cold chain system, including during times of health emergency and disaster.
• Prepare an annual forecast of vaccines and immunization supplies with set standards
for calculation of sub-national needs
• Procure immunization supplies such as vaccines and diluents, AD syringes, mixing
syringes, and safety collector boxes
• Consolidate and analyze data on inventory, vaccine utilization, and wastage
• Support sub-national capacity-building through technical assistance and offering/
exploring training opportunities relevant to vaccine and cold chain management
• Conduct periodic field monitoring and supportive supervision
• Oversee upgrading of the national cold chain system, including resources to provide
cold chain equipment such as, but not limited to, vaccine carriers, cold transport
boxes, vaccine fridges, ice pack freezers, cold room, cold chain temperature
monitoring devices, and relevant information, education and communication (IEC)
materials
• Conduct periodic national cold chain inventory and assessment of effective vaccine
management (EVM), including cold chain equipment functionality at all levels
• Develop Policies, Guidelines, and tools for the management, storage, distribution, and
transport of vaccines in coordination with Supply Chain Management
• Implement the national plan to strengthen Cold Chain Management including
vaccines
• Maintain, manage, and analyze national database on vaccine distribution
• Provide inventory reports to DOH (SCM, DPCB, Finance, COA)
• Act as a member of the technical working group in relation to the procurement of all
vaccines, supplies, and other ancillaries, if needed
• Ensures that vaccines are in good quality
• Recommends measures to DOH for the improvement, expansion, and rehabilitation
needed
1.4.2.2 Regional Cold Chain Manager
• Receive, store, and manage vaccines properly
• Maintain cold chain facility and equipment in good condition, including maintenance
of ideal storage temperature at all times
• Maintain and manage the regional database on vaccines and immunization supply in
coordination with the regional supply officer
• Coordinate with the Regional NIP coordinator to implement the regional vaccine
allocation and distribution plan, making necessary adjustments based on data
analysis on vaccine requisition, distribution, utilization, wastage, and inventory
• Calculate the annual and quarterly vaccine and immunization supply requirement
based on national standards and the recommended buffer stock
• Furnish the Regional NIP Coordinator and Cold Chain Manager with the provincial /
city vaccine and immunization supply allocation and distribution plan
• Ensure adequate and timely receipt and delivery of vaccines and immunization
supplies
• Ensure data collection, consolidation, validation, analysis of provincial/city report
submission on vaccine requisition, distribution, utilization, wastage, and inventory
• Conduct quarterly inventory of vaccines and annual inventory of cold chain
equipment
• Conduct field monitoring, training and supportive supervision on cold chain and
logistics management
• Provide relevant training, and supportive supervision
• Immediately alert the Regional NIP Coordinator and Cold Chain Manager on risks of
vaccine stock-out at any level of the vaccine supply chain
• Monitor functionality and recommend upgrading of the cold chain system, as needed
1.4.4 Municipal Health Office/ Rural Health Unit / Health Center Level
• Calculate annual and quarterly vaccine and immunization supply requirements based
on national standards and recommended buffer stock and share the information with
the Provincial / City NIP Coordinator and Cold Chain Officer
• Ensure timely and adequate receipt and delivery of vaccines and immunization
supplies
• Ensure monthly report submission to the Provincial NIP Coordinator and Cold Chain
Manager on vaccine requisition, distribution, utilization, wastage, inventory, and cold
chain equipment inventory
• Immediately alert the Provincial / City NIP Coordinator and Cold Chain Manager on
any risk of vaccine stock-out
This chapter introduces the different principles and guidelines for managing
vaccines and the cold chain system.
At the end of this chapter, the NIP Coordinator and Cold Chain Manager
will be able to understand the basic principles, importance and uses of the
following:
All health facilities using and storing vaccines should promptly submit a duly signed report
of wasted vaccines regardless of the cause (such as expiration, frozen vaccines, VVM at
discard point or excessive withdrawal of vaccines from vials, theft or breakage).
TABLE 2.
Causes of vaccine Vaccine wastage in unopened vials Vaccine wastage in opened vials
wastage in unopened
Expiration Discarding remaining doses at end of
and opened vials immunization session not in accordance
VVM at dicard point
with the multi-dose vial policy (MDVP).
Exposure to heat or freezing (Refer to the latest MDVP guideline)
temperatures
Doses administered below the number
Breakage of doses indicated on the label of a vial
Missing inventory Poor or improper reconstitution
practices
Theft
Opened vials submerged in water
Discarding unused vials from an
outreach session Suspected contamination
Patient reaction requiring more than
one dose
Administration of incorrect dosage
Very few children showing up during
immunization session
The wastage rate is the expected percentage of vaccine vials that will be discarded or not
fully used. Table 3 shows the WHO standard wastage rate and their equivalent wastage
factor. The wastage factor is used in calculating vaccine needs.
The NIP will use the WHO recommended wastage rate and wastage factor, as specified in
Table 3.
Note that each vaccine type has a different wastage rate, which can be calculated using
the formula below. This formula applies to all administrative levels for monitoring and
reporting wastage rate.
Formula for Formula for computing the vaccine Wastage Rate (WR):
computing the WR = Number of doses supplied - Number of dose administered x 100
vaccine Wastage Number of doses supplied
Rate (WR)
Example: A facility received 200 doses of a vaccine. Of this, 150 doses were
administered.
Note: The doses supplied is calculated from stock recorded for a given time
period by adding the starting balance of usable vaccine doses to new doses
received during the period and subtracting the ending balance:
Doses supplied =
(Starting balance of viable doses + new doses received) – ending balance
The formula for computing wastage factor based on defined wastage rate
is as follows:
Example: Assume that the wastage rate of a vaccine is 25%. Using the
formula, the WF will be:
WF = 100 = 1.33
100-25
Interpretation: This means that for every administered dose of this particular
antigen, 1.33 dose is needed to compensate for the 25% wastage.
Given Values:
Number of used doses for routine immunization in a month: 150 doses
Number of doses administered to children in a month: 100 doses
Total Wasted Doses: 50 doses (30 doses wasted during immunization session + 20 doses discarded)
1 = 1
1-0.33 1- 1
3
1 = 3 = 1.5
0.67 2
Figure 2 illustrates the proportion of MMR vaccine wasted in Health Center A in every
reporting cycle.
From the example, the estimated wastage rate of MMR in Health Center A is 33%, which
is higher than the national standard. This should be investigated as to why the wastage is
higher. Health Center A may rquest for additional MMR vaccines to cover the wastage.
FIGURE 2.
Proportion of MMR Vaccine Wasted in Health Center A
50 50 30 20
The wastage factor given for other immunization supplies to avoid shortage is set at 1.11,
which is equivalent to 10% wastage rate. This wastage factor is used for estimating the
needs for AD syringes, mixing syringes and safety boxes.
“All opened WHO prequalified multi-dose vials of vaccines should be discarded at the end
of the immunization sessions, or within six hours of opening, whichever comes first unless
the vaccine meets all of the criteria listed below. If the vaccine meets the four criteria,
the opened vial can be kept and used for up to 28 days after opening.” (WHO Policy
Statement: Multi-Dose Vial Policy [MDVP], Revision 2014 Handling of Multi-Dose Vaccine
The WHO policy document spells out the following criteria for the vaccines:
In addition to the WHO statement, the DOH also highlights that MDVP policy only applies
when the opened vaccine vials have no sign of breakage or contamination and aseptic
technique has been observed throughout the handling of the vaccine vial. Vials after
Opening)
All vaccine stores are expected to strictly follow and maintain the ideal buffer stock at all
times. In case of vaccine shortage or significant delay in national procurement or delayed
arrival of vaccines, the buffer stock may be temporarily adjusted to at least one month
until a sufficient supply of vaccine is available to maintain the ideal buffer stock. The NIP
and national vaccine store shall issue an advisory in case of any significant delay in the
procurement of vaccines. The cold chain manager/ supply officer should closely coordinate
and monitor stock level at the higher level vaccine store.
TABLE 4.
DOH-Recommended Buffer Stock Level and Usual Distribution Cycle
The stock management record (Annexes 2 and 3) is used to monitor the availability of
vaccines and immunization supplies against the minimum and maximum stock levels; order
adequate monthly or quarterly supplies; and distribute supplies to peripheral levels on a
timely basis. This record should be updated regularly through physical or manual count of
supplies. The stock record should be adjusted as needed.
The use of a continuous time temperature monitoring device (Annex 11) is one way of
ensuring that the cold chain equipment is functional (that is, always maintained at the
recommended storage temperature for vaccines). In addition, a freeze indicator is required
to detect whether freeze-sensitive vaccines were exposed to a freezing temperature.
Using bimetal, alcohol-stem type, or integrated thermometers are not reliable indicators
as temperatures are only obtained on the spot (that is, when the health workers read
the temperature display). On weekends and holidays when nobody is in the facility, the
reliability of the cold chain equipment is not assured.
Whether the continuous time temperature monitoring device or on the spot thermometer is
used, temperatures of the equipment still have to be recorded at least twice daily: first thing
in the morning and before leaving the post in the afternoon, seven days a week (including
Make sure vaccine boxes are arranged with adequate spacing in-between and that tray
boxes are used to allow internal air circulation. This helps maintain proper temperature
inside the unit. (Do not remove the basket/tray inside the ice-lined vaccine refrigerators.)
What is important to keep in mind is all the immunization supplies are calculated and
scheduled for delivery in such a way that the number of injection safety devices matches
the number of doses of vaccines to be delivered to the recipient store in the same period.
Bundling applies to delivery of supplies from regional level to the LGU.
However, at the service delivery point - especially when conducting outreach vaccination
session - matching vaccines, diluents and injection safety equipment should be brought
together by the vaccination team in charge of the vaccination session. Any unused
logistics should be returned to the store for use in the next vaccination session.
The tool for bundling calculation is found in Annex 1. An example of calculating bundled
immunization logistics using a standard excel tool is shown in Table 6.
Number
Target of doses Doses Wastage Wastage 0.05 0.5 ml 2 ml 5 ml
Doses Safety
Vaccines popula- per per factor for factor for ml AD AD mixing mixing Diluent Droppers
needed boxes
tion target vial vaccines syringes syringes syringes syringes syringes
group
A B C D E F= G H= I= J=F/D K=F/D L=F/D M=F/D N=
B*C*E B*C*G B*C*G (H+I+J+K)
/100
BCG 130,000 1 20 2.50 325,000 1.11 144,300 16,250 16,250 1,606
HepB 130,000 1 10 1.18 153,400 1.11 144,300 1,443
Pentavalent 130,000 3 1 1.05 409,500 1.11 432,900 4,329
bOPV 130,000 3 20 1.33 518,700 25.935
PCV 130,000 3 1 1.05 460,200 1.11 432,900 4,329
IPV 130,000 1 10 1.18 136,500 1.11 144,300 1,443
MMR 130,000 2 5 1.33 345,800 1.11 288,600 69,160 69,160 3,578
MR 130,000 2 10 1.33 345,800 1.11 288,600 34,580 34,580 3,232
Td 130,000 2 10 1.18 306,800 1.11 288,600 2,886
(Adolescent)
Td (Pregnant) 130,000 2 10 1.18 306,800 1.11 288,600 2,886
JE 130,000 1 5 1.33 172,900 1.11 144,300 34,580 34,580 1,789
HPV 130,000 2 1 1.05 273,000 1.11 288,600 2,886
PPV 130,000 1 1 1.05 136,500 1.11 144,300 1,443
Flu 130,000 1 10 1.18 153,400 1.11 144,300 1,443
Rotavirus 130,000 2 1 1.05 273,000
The shake test tells you whether your suspected vials have been damaged by freezing.
Do the shake test when the temperature monitoring device indicates temperature
exposures below 0° or if a freeze-sensitive vaccine was left in direct contact with a frozen
icepack. Both the Cold Chain Manager and NIP Coordinator should be trained to perform
the shake test.
Only the vaccine vial suspected of freezing should be tested. For better comparison, use
a minimum of five vials to conduct the shake test. Do not conduct the shake test for a
vaccine vial that is already frozen. The frozen vial should be reported as wastage and
disposed of.
FIGURE 3.
Samples of frozen vaccine vials of Tetanus toxoid (right) and DPT (left)
Note: The Shake Test is not applicable to IPV. IPV suspected of freezing needs to be discarded immediately.
a. Select one vial from each type and batch of SUSPECT vaccines as CONTROL sample.
Freeze the control vials until they are solid frozen and label them “FROZEN”.
b. Allow the FROZEN control vials to thaw completely.
c. Shake the FROZEN control and SUSPECT vials from the same batch in one hand for
10 to 15 seconds.
d. Observe the sedimentation rate on both vials (the FROZEN control and the SUSPECT
vials) by placing both on a flat surface side-by-side in a well-lighted location. Natural
light is better. The sediments on the suspect vial fall to the bottom of the vials faster
or at the same rate.
2.6.2 Subsequent Action if Shake Test indicated that Vaccine was Frozen
Expired vaccine vials should be properly recorded in the vaccine stock card and disposed
of immediately (after accounting and auditing procedures have been completed), labelled
and stored outside the cold chain to avoid being mixed with unexpired vaccines.
FIGURE 6.
VVM label locations
• Aside from checking the expiration date, always check the VVM status:
› When receiving a vaccine shipment: If the cold chain temperature monitoring
device, such as a fridge tag, displays a high temperature alarm, it is possible
that temperatures of more than +8°C for a continuous time of at least 10 hours
occurred. If this occurs, randomly check the VVM and do not accept the delivery if
the VVM reached discard point.
› When preparing vaccines for distribution to health facilities or during immunization
outreach activities: Do not distribute vaccines with VVM that reached discard
point.
› Before opening a vaccine vial for an immunization session: Check VVM status to
see if the vaccine has been damaged by heat. Do not administer vaccines with
VVM that reached discard point.
• VVMs do not measure exposure to freezing temperatures (for freeze-sensitive
vaccines). A VVM still at start point does not exclude the possibility that the vaccine
has been frozen. If a freeze-sensitive vaccine with VVM still at start point is
suspected to have been frozen, perform a shake test.
Checking for the status of VVM is easy but can be tricky. Check the VVM under natural
lighting to properly view the degree of change in color of the VVM on the vial. Figure 8
provides a simple guide for interpreting the status of VVM on a vaccine vial.
The starting color of the square inside the Once a vaccine has reached or
VVM always has a bluish-gray tinge; is never exceeded the discard point, the color
perfectly white. The inner square remains lighter of the inner square will be the same
than the outer circle until the temperature and/ color or darker than the outer circle.
or duration of heat reaches a level known to
degrade the vaccine beyond acceptable limits.
2.8.3 General Guidelines when Using the VVM for Immunization Sessions
taking place outside of the Health Facility
• During distribution, always maintain vaccines in the cold chain as long as possible.
This ensures the maximum viable life of the vaccine in the field.
• Health workers and others handling the vaccines must be trained to interpret VVM
readings correctly. They must also be trained on how to properly discard vaccine vials
with VVM at discard point.
• Remember that freeze-dried vaccines (measles, BCG, yellow fever, and freeze-dried
formulations of Hib) lack either adjuvant, preservative or both. Thus, these vaccines
should not be transported to their point of use if the availability of ice cannot be
guaranteed. Ice is necessary in order to keep the vaccines cool and potent after
reconstitution.
• Conditions where vaccines can be taken out of health facility and where cold chain
must still be maintained:
› Outreach immunization sessions
› School-based vaccination activity
› Mass immunization activity
› Outbreak response immunization
› House-to-house vaccination activity
› Storage and transportation of freeze-sensitive vaccines (Hepatitis B, Hib Vaccine,
DPT, TT, TD, Td, Pentavalent vaccine) where the risk of freezing is greater than the
risk of heat exposure
Vaccine inventory must be regularly monitored either manually using the Stock
Management Record for vaccines, diluents and safe injection devices (Annex 2 and 3,
respectively) or through an electronic monitoring system (if available). Once the stock level
goes down to the level of the buffer stock even prior to the next delivery cycle, immediately
send an order to the vaccine store at the next higher level. The reason for rapid depletion
of stocks should be determined and corrected if it is due to poor management of supply.
This proactive action will prevent stock-outs. A sample of the Vaccine Stock Card is shown
in Table 8.
Beginning Balance
Ice packs are leak-proof containers complying with performance, quality and safety (PQS)
specifications, filled with tap water or with a phase-change material (PCM). PCM is a
substance other than water with a high heat of fusion. PCM melts and solidifies at a
certain temperature and is capable of storing and releasing large amounts of energy.
FIGURE 9.
Sample of Ice Packs
These are taken directly from a freezer between -20°C and -25°C. When frozen ice packs
are placed in a passive container, the container temperature immediately drops to below
0°C and stays there for a period of up to several hours. For this reason, they must never be
used to transport freeze-sensitive vaccines even if they ensure a long cold life.
These ice packs contain liquid water at an initial temperature of between +2°C and +8°C.
Cool water packs eliminate the freezing risk, but cold water lacks the cooling performance
of ice and protects vaccines for a much shorter period of time. Use of cool water packs
is validated based on the argument that it is safe to expose vaccines other than OPV to
temperatures of up to +20°C for short time periods but only if the vaccines have VVMs.
These are ice packs that have been removed from the freezer and left at room temperature
until they begin to melt and contain a mixture of ice and water at a temperature of about
0°C. Ice pack conditioning eliminates freezing risk without much reduction to cold life.
The proper freezing and use of ice-packs is essential for good quality of the vaccines.
Make sure that ice packs used correspond to the size and number required for each type of
temporary cold chain equipment such as vaccine carriers and transport cold boxes.
a. Fill the ice pack container with tap water, leaving a little air space at the top, and
screw the cap tightly.
b. Hold each ice pack upside down and squeeze to ensure it does not leak.
c. Place the ice packs upright or on their sides in the freezer so that the surface of each
pack touch the evaporator plate (Figure 10) and close the freezer door tightly.
d. Leave ice packs in the freezer for at least 24 hours to ensure solid freezing.
e. After the immunization session, put the ice packs back in the freezer.
FIGURE 10.
Layering Ice Packs inside the Freezer
If all the ice packs do not fit into the freezer, place the extra frozen packs at the bottom
of the main refrigerator compartment. This will keep this section cold in case of a power
outage. Ice packs placed in the freezer will freeze relatively quickly as the water inside is
already cold. Do NOT store already frozen ice packs in the refrigerator compartment as
this will increase the risk of freezing vaccines.
Ice pack conditioning is a process of removing ice packs from a freezer at - 25°C and
keeping them at room temperature long enough to allow the packs’ core temperature to
rise to 0°C. The guideline is that an ice pack is adequately “conditioned” as soon as beads
of water cover its surface.
The time it takes to condition ice packs varies depending on the ambient temperature. It
can take more than 30 minutes.
• Remove ice packs from the freezer compartment and keep them at room temperature
until the ice melts.
• Shake the ice packs one at a time every few minutes as shown in Figure 11.
• Once the sound of water moving inside is heard, the ice packs are ready to be loaded
into the cold box or vaccine carrier.
FIGURE 11.
Checking Conditioned Ice Packs.
Left: Shaking the ice packs to ensure that sound of moving water is heard. Right: Ice packs being melted
at room temperature.
• There is no need to refill the ice packs after every use. Use the same water repeatedly.
• Clean the ice pack containers before putting them back into the freezer
• Never use vaccine ice packs to transport specimens to the laboratory and vice versa.
• In case ice packs were used for another purpose, ensure that each ice pack container
is thoroughly disinfected and the water replaced before using them for vaccines.
Consult your sanitation officer for guidance on proper disinfection.
• Never use ice packs with signs of breakage or contamination (such as growth of
molds) for storing or transporting vaccines or medicines.
At the end of this chapter, the NIP coordinator and cold chain manager will be
able to:
The following parameters are necessary to properly calculate the annual requirement for
vaccines and immunization supply:
• Total projected population – use the official projected population from the Philippine
Statistics Authority (PSA), as endorsed by the DOH
• Target population or eligible population – calculated using a multiplication factor
established by NIP
• Recommended number of doses – use vaccine-specific required number of doses
• Number of doses per vial for each vaccine – check the package insert that comes
with the vaccine
• Wastage factor – use vaccine-specific wastage factor
• Vaccine distribution cycle – depending on the store level
• Recommended buffer stock – depending on the store level
The same basic formula presented in this chapter will be used for calculating the
requirement regardless of the delivery cycle. However, the resulting figure has to be
divided by either 4 or 12 when estimating quarterly or monthly needs, respectively.
Then, calculate the number of vials required annually per vaccine using the following
formula.
Annual Requirement =
Further, both the WHO and UNICEF recommended to always aim for
100% coverage in calculating the annual vaccine requirement for routine
immunization because every child has a right to immunization. Any
adjustments on the target coverage shall be made only if DOH has a
budgetary constraint in procuring vaccines. In this case, adjusting the target
coverage to 95% coverage to achieve the National Objectives for Health is
conditionally acceptable.
Prior to submission of the requisition, check that the required buffer stock is maintained.
This will help prevent stockouts in case of procurement or delivery delays.
Assess existing vaccine cold chain storage capacity to plan the appropriate delivery
cycle per vaccine store. The recommended sub-national delivery cycle for vaccines and
immunization supply is quarterly for the region, province, city and district levels, while
monthly for municipal, RHU, HC and BHS levels. However, the delivery schedule may be
more frequent in areas where cold chain storage capacity is limited.
Mixing Syringes =
Stock-outs resulted in missed opportunities to vaccinate the eligible population. The NIP
requires strict compliance with the required quarterly vaccine inventory and to submit the
inventory status report to the next higher levels through the Vaccine Usage and Wastage
Reporting Form (Figure 12).
• Stock available for the reporting month – provides information on the quantity of
vaccines received during the previous month from all sources and those returned or
distributed to other health facilities
• Utilization and wastage report – contains data on the quantity of vaccines wasted,
used for immunization service delivery, vials unused and estimation of the wastage
rate
• Inventory report – indicates the ending balance of the vaccines available for use
in the current month and other relevant information, such as the reason for high
wastage rate, among others.
3.3.3 How to fill out the Vaccine Usage and Wastage Reporting Form
This form is completed at and submitted to the next higher level by the health facility
providing immunization services. The following table provides a stepwise guidance in
completing the Vaccine Usage and Wastage Reporting Form.
The data in the submitted form is consolidated at the next higher level using the Vaccine
Usage and Wastage Consolidation Database. Figure 13 is an example of the database.
Data for each vaccine is encoded in separate worksheets. Except for the first column which
lists all the catchment area of a given health facility, the rest of the columns are similar to
the Vaccine Usage and Wastage Reporting Form.
Name of Facility: _________________________________________________ Reporting Month: _________________ Date of Report: __________________ Reported by:____________________________________________
Name of Region: ______________________ Name of Province: __________________________________ Name of City/Municipality: ____________________________________
Reporting Level: Province City/Municipality Barangay Others (please specify): ______________
INVENTORY
STOCK AVAILABLE FOR THE REPORTING MONTH UTILIZATION AND WASTAGE REPORT
REPORT
a b c d e f g h i j k l m n o p q r s t u v w
BCG 20
HepB 10
Pentavalent 1
bOPV 20
Sample Vaccine Usage and Wastage Reporting Form
IPV 10
PCV 1
MR 10
MMR 5
Rotavirus 1
Td 10
HPV 1
JE 5
TT 20
Measles 10
Dengvaxia 5
Flu 10
PPV23 1
59
***Based on actual physical count or inventory after the last immunization session of the reporting month.
60
Consolidation Report Form 2: Vaccine Usage and Wastage Database
FIGURE 13.
INVENTORY
STOCK AVAILABLE FOR THE REPORTING MONTH UTILIZATION AND WASTAGE REPORT
REPORT
# of Vials Administered
# of vials Total stock available
# of vials # of unopened
received for the reporting Vials Discarded
# of vials returned # of vials vials Ending
Name of Baran- Starting from month Wasted
received to higher available # of utilized vials balance
gay/Municipality/ balance higher doses
from any level or for Wastage (in vials)
Province/City (in vials) level or during
source trans- routine # of doses Rate for the Remarks
for the other immuni-
in the ferred immuni- adminis- # of vials report-
reporting sources Total Total zation # of
reporting to other # of # of vials zation tered # of # of kept ing
month for the # of vials # of vials # of vials Discarded Discarded (p-n) doses
month* health doses with (f-k) opened doses at the month
reporting (b+c+d)-e expired damaged Vials in Doses (b7
facility (b7 x f) VVM 3/4 vials** (b7 x o) facility
month (h+i+j) (b7 x k) x r)
***
a b c d e f g h i j k l m n o p q r s t u v
Total
Sample of Vaccine Usage and Wastage Consolidation Database
Once the name of the reporting unit is encoded in the first column of the first vaccine
worksheet, the database will automatically generate the name of the reporting unit in all
active sheets, e.g. for the rest of the vaccine worksheets. This facilitates easy encoding.
Data encoded in each vaccine worksheet is automatically consolidated in the summary
Worksheet. The tool automatically provides a graphical analysis of the consolidated data
(Figure 14).
Proper planning for vaccine allocation, requisition and distribution will be guided by the
information collected from this reporting requirement. Ideally, the higher level vaccine
store should review the stock level, rate of vaccine utilization and wastage for the
previous period and make the necessary adjustment either by increasing or reducing
the allocation for the next delivery. It is also important for the supplying vaccine store to
check the sufficiency of the cold chain capacity and buffer stock of the receiving store
prior to delivery.
Finally, it is important to place the order one month or at least two weeks prior to the
next delivery schedule. This will allow sufficient time for the supplying vaccine store to
prepare and deliver the vaccines and logistics on time.
Care must be taken when calculating syringes because there are several vaccines
requiring the use of AD and mixing syringes. When estimating the quantity to be ordered,
review first the total number of vaccine doses requested for the current delivery period
that would require 0.05 ml AD syringes, 0.5 ml AD syringes and the corresponding mixing
syringes.
Figures 15 and 16 are examples of the Vaccine and Safe Injection Equipment Request
Form used by the RHO, PHO, CHO and health centers. Only duly completed and signed,
the VRF will be processed for vaccine delivery. The higher level vaccine store reserves
the right to review the request and make necessary adjustments in the actual quantity to
be delivered for the current delivery period. The adjustment will be based on the review
of the data contained in the order form against the data in the Vaccine Usage and
Wastage Form.
Instruction: Please do not forget to fill-up all columns and the total population of the requesting facility.
All vaccine quantity are calculated in vials.
EPI Vaccines Previous Quantity Quantity Quantity Current Quarterly Buffer Recom- Current Remarks
Stock received issued Damaged, Stock require- Stock mended order/
from Expired, ment Stock request
previous Loss, Etc.) f = (b + c) Level
order - (d + e) h=g i = (g + h) j = (i - f)
a b c d e f g h i j k
BCG (20-dose/vial)
Hepatitis B
(10-dose/vial)
DPT-HepB-HiB
(1-dose/vial)
Bivalent Oral Polio
Vaccine (20-dose/
vial)
Pneumococcal
Conjugate Vaccine
(1-dose/vial)
Inactivated Polio
Vaccine (IPV) (10-
dose/vial)
Measles Mumps
Rubella (5-dose/
vial)
Tetanus diptheria,
Adolescent (10-
dose/vial)
Tetanus diptheria,
Pregnant Women
(10-dose/vial)
Measles Rubella
(10-dose/vial)
Japanese Enceph-
alitis (5-dose/vial)
Rotavirus Vaccine
(1-dose/vial)
Human Papillo-
mavirus Vaccine
(1-dose/vial)
Pneumococcal
Polysaccharide
Vaccine (1-dose/
vial)
Influenza Vaccine
(10-dose/vial)
EPI Vaccines Previous Quantity Quantity Quantity Current Quarterly Buffer Recom- Current Remarks
Stock received issued Damaged, Stock require- Stock mended order/
from Expired, ment Stock request
previous Loss, Etc.) f = (b + c) Level
order - (d + e) h=g i = (g + h) j = (i - f)
a b c d e f g h i j k
bOPV droppers
Safety boxes
0.05ml AD syringes
for BCG
0.05ml AD syringes
(total quantity)
Hepatitis B (10-
dose/vial)
DPT-HepB-HiB
(1-dose/vial)
Pneumococcal
Conjugate Vac-
cine (1-dose/vial)
Inactivated Polio
Vaccine (IPV)
(10-dose/vial)
Measles Mumps
Rubella(5-dose/
vial)
Tetanus diptheria,
Adolescent
(10-dose/vial)
Tetanus diptheria,
Pregnant Women
(10-dose/vial)
Measles Rubella
(10-dose/vial)
Japanese Enceph-
alitis (5-dose/vial)
Human Papillo-
mavirus Vaccine
(1-dose/vial)
Pneumococcal
Polysaccharide
Vaccine (1-dose/
vial)
Influenza Vaccine
(10-dose/vial)
2 ml or 3 ml Mixing
syringes for BCG
5 ml Mixing syringes
(total quantity)
Measles Mumps
Rubella (5-dose/
vial)
Measles Rubella
(10-dose/vial)
Japanese Enceph-
alitis (5-dose/vial)
The recommended timing for submitting requests for vaccine replenishment is as follows:
Each health worker or staff in-charge should understand the basic principles
of storing vaccines and safe injection equipment. Recipient and sending
facilities are responsible for thoroughly checking vaccine quantity and
condition (state of the VVM, potency, expiration, and undamaged state),
appropriateness of transport equipment used and temperature upon
receipt and prior to delivery. Other immunization supplies such diluents,
OPV droppers, syringes and safety boxes should be adequate, in good
condition, and should properly match the vaccines delivered. It is important
to keep in mind to provide only diluents from the same vaccine lot/batch and
manufacturer.
TABLE 13.
Recommended Actions during Vaccines Pre-Arrival and Arrival
Provincial/ RHU/
Actions National Regional
City BHS
Vaccines pre-arrival checklist
Inform details of vaccine arrival and distribution Yes Yes Yes N/A
Vaccines arrival checklist
Check completeness of documents of the vaccines:
• Air way bill Yes Yes N/A N/A
• Bill of lading Yes Yes N/A N/A
• Way bill Yes N/A Yes Yes
• Packing list Yes Yes Yes Yes
• Invoice receipt Yes N/A Yes Yes
Open the boxes and check the temperature (if accompanied Yes Yes Yes N/A
by temperature monitoring device) and the presence and
condition of ice packs
Check status of the ice packs Yes Yes Yes N/A
If the ice packs are either fully melted or frozen hard inform
immediate supervisor for appropriate action
Check VVM status and note any color change and include in Yes Yes Yes Yes
the report
Check expiry date and lot number of each vaccine type. There Yes Yes Yes Yes
may be more than one expiry date and lot number of a single
vaccine type in the consignment
Count the vaccines and compare the quantity recorded in the Yes Yes Yes Yes
documents
Fill up the Vaccine Arrival Report (VAR), including condition of Yes Yes Yes N/A
the vaccines and submit to appropriate body
Immediately transfer and organize the vaccines in the cold Yes Yes Yes Yes
room/freezer room or vaccine refrigerator/freezer
Record the vaccine quantity received, lot number, expiry date, Yes Yes Yes Yes
status of VVM and other needed information in the vaccine
control card or stock card
Prepare and submit report to Supervisor Yes Yes Yes Yes
Immediately report any concern to the next higher level Yes Yes Yes Yes
Ensure that the Invoice Receipt for Property (IRP) contains all the following:
A sample Invoice Receipt of Property form is found in Annex 7. If there are discrepancies
such as short dating and/or supplies that cannot be used before they expire, contact the
supplier and report the problem.
The Vaccine Arrival Report (VAR) serves as the confirmation of receipt of vaccines by the
requesting store. It also serves as a supporting document for the request for replacement
of vaccines that are damaged during shipment. The form should be completed and
submitted to the supplying store within three days of vaccine receipt. This form is used
only at the RHO, PHO and CHO levels. The standard VAR forms are found in Annexes 8
and 9, while the Bill of Lading is found in Annex 10.
The VAR contains information on the confirmation of the consignee’s receipt of an advance
notice; arrival details; and, details on the quantity, lot number, expiration date, number
of delivered boxes, types of documents (such as invoice, bill of lading, and packing list)
received along with the delivered vaccines); status of VVM and accompanying ice packs;
temperature recording at the time of arrival; and, the general condition of the shipment.
Ideally vaccines delivered to the regional level should have an expiration date of not less
than six (6) months’ time. However, if the vaccine is close to expiry within a few months
(such as less than 3 months), DOH will issue prior advice on consumption of the vaccine
within the expiry date.
Vaccines are sensitive to heat, freezing and light. Vaccine cold storage
temperature should be checked at least twice daily. Every time an order or
request for vaccines is made, staff concerned must consider the latest vaccine
inventory and cold storage capacity of the requesting facility. This is to ensure
that vaccines’ safety and potency will not be compromised during storage
and that these are maintained until the vaccines are administered to the
eligible populations.
The following general guidelines must be followed in order to avoid contamination and
wastage of materials:
• Clean and disinfect the storeroom regularly to discourage harmful insects and
rodents from entering the storage area.
• Store injection safety commodities in a dry, well-lit and well-ventilated storeroom.
• Keep the storeroom free from dampness.
• Keep vaccines away from direct sunlight.
• Make functional fire safety equipment available.
• Store latex products away from electric motors and fluorescent lights.
• Limit access to the storage area to authorized personnel.
• Stack cartons at least 10 cm (4 inches) off the floor, 30 cm (one foot) away from the
walls and from other stacks, and no more than 2.5 m (8 ft) high.
• Arrange cartons with arrows pointing up and with identification labels and with
manufacturing and expiry dates clearly visible.
• Store health commodities away from chemicals, flammable products and hazardous
materials.
• Separate damaged and expired health commodities from usable commodities.
• Keep narcotics and other controlled substances in a locked place.
• Store flammable products separately with appropriate safety precautions.
Temperature ranges for which vaccines are stored at each cold chain level are shown in
the table below.
The following two tables show the common risk factors leading to vaccines’ exposure to
heat or freezing and the corresponding actions to mitigate these risks.
TABLE 17.
Causes of Heat Exposure and Recommended Actions
During storage
• Electrical power failures causing • Install standby generators to provide backup power in large vaccine
breaks in the cold chain stores
• Cold chain equipment breakdown • Use appropriate cold rooms, freezer rooms, refrigerators, freezers, cold
(refrigeration system or solar boxes and vaccine carriers for storage of EPI vaccines. WHO/UNICEF
power system) PQS compliant equipment are highly recommended.
• Storing vaccines in non-medical • Choose a power source (electricity or solar) that is appropriate to the
cold chain equipment like domestic location and the climatic conditions
refrigerators or freezers which are
• Conduct routine monitoring, recording and analysis of cold chain
not designed for heat and freeze
temperatures collected from temperature monitoring devices
sensitive vaccine.
• Set thermostat correctly
• Wrong thermostat setting
• Replace old and broken door seal / gasket
• Broken door seal / gasket
• Develop and implement contingency plans
• Carry out standard operating procedures (SOP) for day-to-day
operations
• Train staff to follow SOPs and equipment manufacturers’ user manuals
During transport
• Passive container packed with • Use correct number and size of ice packs as recommended by the
too few or inappropriately sized manufacturer
coolant packs
• Use cold box and vaccine carrier with long cold life for specific
• Delivery or outreach trip exceeding applications
the passive container’s cold life
• Proactively maintain vehicles in good condition for transport of
• Vehicle breakdown vaccines
• Refrigeration system breakdown • Park vehicles in a shaded area
for refrigerated vehicles
• Parking vehicles in direct sunlight
During immunization sessions
• Exposure of vaccines to high • Use foam pad to keep vaccines cool during immunization sessions
temperature during immunization
• Use WHO/UNICEF PQS compliant vaccine carrier and appropriate
sessions
number of ice packs
TABLE 18.
Causes of Freeze Exposure and Recommended Actions
During storage
• Storing freeze-sensitive vaccines close to the surface • Arrange vaccines appropriately in the refrigerator
of the evaporator of the refrigerator or cooler
• Adjust thermostat setting following manufacturers’
• Incorrect thermostat adjustment in refrigerator or instructions
walk-in coolers with adjustable thermostats
• Use vaccine baskets provided by the manufacturer
• Failure to use baskets supplied with ice-lined
• Use WHO/UNICEF PQS compliant refrigerators for
refrigerators, allowing freeze-sensitive vaccines to be
storing vaccines
stored outside the manufacturer’s designated safe
storage zone • Conduct routine monitoring, recording and
analysis of cold chain temperatures collected from
• Storing freeze-sensitive vaccines in domestic
temperature monitoring devices
refrigerators in close proximity to the evaporator
plate • Recognize damaged vaccines through Shake Test
(not applicable to IPV)
• Defective thermostat
• Replace correct specification thermostat.
During transport
• Packing freeze-sensitive vaccines in passive • Use correct number of conditioned ice packs in
containers with unconditioned ice-packs packing freeze-sensitive vaccines
• Transporting freeze-sensitive vaccines in refrigerated • Correct use of cold boxes and vaccine carriers for
vehicles that are poorly maintained and/or incorrectly vaccine transport
packed
As a general rule when receiving vaccine deliveries, always check for the presence of a
temperature monitoring device and record the temperature reading upon opening of the
box. If an electronic device is used, it has to be stopped and the temperature recorded
in memory should be checked and verified for any temperature excursions that may
potentially cause damage to the vaccines.
This temperature monitoring device is primarily used for international shipment of vaccines.
Upon receipt at the national vaccine store, the indicator has to be stopped and
temperatures recorded have to be checked and verified for any temperature excursions
that may cause damage to the shipment. This can be the basis to request replacement of
damaged vaccines either by heat or by freezing.
These are small digital devices placed with freeze-sensitive vaccines during transport or
storage. The device has a visual indicator showing whether the vaccine has been exposed
to freezing temperatures. Once the alarm indicator is triggered, the device is no longer
usable and should be discarded. Otherwise, the device can be used until the built-in
battery expires.
If the freeze indicator displays an alarm or ‘X’ symbol, the health worker should conduct
the Shake Test to verify if vaccine has been damaged by freezing.
This is a computerized temperature recording system. It is the best option for primary
and sub-national stores equipped cold room and freezer room. This is directly linked to a
central computer-based monitoring hub via wired or wireless connections. Multilog 2 is
an example of a continuous temperature monitoring device. Its sensors are connected at
different locations inside the cold room or freezer room. The Multilog 2 is connected to a
computer which can print the temperature readings in graphical or tabular form.
This is a wireless temperature monitoring solution for refrigerators, cold rooms, and freezer
rooms that are used to store vaccines and other temperature-sensitive products. The
Internet-enabled system goes far beyond temperature alerts and alarms. It collects critical
data and provides customizable analytics and report-generating tools to empower health
workers, inform ministries of health, and improve overall cold chain performance.
This temperature monitoring device records and displays a 30-day history of any heat and
freeze alarm violations that have occurred. Alarms are triggered if the temperature in the
refrigerator drops to –0.5°C or below for 60 minutes or if it exceeds +8°C for a continuous
period of 10 hours. As long as the temperature has remained within the recommended
range, the device displays an “OK” or a tick symbol. On newer models data can be
downloaded to a computer via a USB interface.
30-DTRs are not designed to be used in vaccine freezers. Current models have built-in
batteries with a battery alarm feature. These devices contain a non-replaceable battery
with a minimum operating life of 2 years from the date of activation. The device must be
activated within 12 months of receipt. The device must be discarded and replaced when
the battery expires.
• If the refrigerator is used to store vaccines that are not freeze sensitive, place the
An internal temperature sensor monitors the coldest point in the vaccine storage
compartment, and an instantaneous temperature reading is displayed on the unit’s
control panel.
Health staff should record the temperature reading inside the refrigerator or freezer if
possible. Otherwise, record the reading in the built-in thermometer.
The bimetallic dial thermometer only provides an instantaneous temperature reading and
has no memory to retain the temperature reading.
The WHO no longer recommends the use of bimetallic dial thermometers for any purpose
because they lose calibration and accuracy overtime, especially if they are dropped.
These temperature monitoring devices are used for temperature mapping of cold rooms,
freezer rooms, vaccine refrigerators and freezers to determine the temperature at every
part of the cold rooms or vaccine refrigerators.
They are also used for temperature monitoring studies to determine the temperature
variation in the vaccine storage facility, flow route of vaccines, transportation facilities and
vaccination sites.
• The sensors for the continuous temperature monitoring device are fixed by the cold
room installer and should not be moved.
• A minimum of four electronic freeze indicators should be placed on the cold room
shelves in front of the vaccines. If temperature mapping has been previously done,
place the devices in places where the lowest temperatures are found.
• Place one electronic device (30-DTR) on the shelf which is closest to the evaporator
air stream from each of the refrigeration units.
• Place two more electronic devices (30-DTR) on the shelves in the center of the cold
room, one on the middle shelf and one on the bottom shelf.
The sensors for the continuous temperature monitoring device are fixed by the freezer
room installer following the manufacturer’s recommendation and should not be moved.
With freeze-sensitive vaccines and conditioned ice packs, place one electronic freeze
indicator to monitor if vaccines have been damaged by freezing due to ice packs that were
not conditioned correctly. Use a thermometer to monitor instantaneous temperature.
With non-freeze sensitive vaccines and frozen ice packs, use one thermometer to
determine the instantaneous temperature.
Health workers managing the vaccines are required to check and take temperature
readings at least twice daily despite the use of 30-DTRs. This will serve as a check and
balance of other temperature monitoring devices and proof of action taken.
• The shaded part of the chart indicates the safe temperature in each compartment.
• The four rows at the bottom allow health staff to record other necessary information
on the history of equipment malfunction or power interruption, including the name of
the daily recorder.
Ideally, other staff should know the ideal temperature for vaccine refrigerators and freezers,
aside from the cold chain manager. This will ensure that temperature monitoring and
recording is maintained in case of absence or transfer of the cold chain manager. Simple
printed guides and algorithms can be visibly displayed in the vaccine store house to guide
other staff on how to perform temperature monitoring and recording in the event the cold
chain manager could not perform the task.
The person in charge of monitoring cold chain temperature should continue to log the
temperature reading twice a day even during weekends and holidays. Alternatively, the
facility staff may agree to come up with a shift schedule of staff who will be in charge of
temperature monitoring and recording during weekends and holidays. Designating other
staff to carry out the task is also important in case the staff responsible is not available
due to sickness, leave of absence or emergency situations.
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
°C am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm
+16
+15
+14
+13
+12
+11
+10
+9
+8
+7
+6
+5
+4
Temperature chart
+3
+2
+1
0
-1
-2
-3
-4
Once every 24 hours, enter high alarm status and maximum temperature recorded by the continuous monitoring
>+8°C alarm device
Alarm time or OK
Maximum °C
Once every 24 hours, enter low alarm status and minimum temperture recorded by the continuous monitoring
<0.5°C alarm device
Alarm time or OK
Minimum °C
Initials:
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
°C am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm
-9
-10
-11
-12
-13
-14
-15
-16
-17
-18
-19
-20
-21
Temperature chart
-22
-23
-24
-25
-26
-27
-28
-29
-30
FI (OK or X)
Once every 24 hours, enter high alarm status and maximum temperature recorded by the continuous monitoring
>+8°C alarm device
Alarm time or OK
Maximum °C
Once every 24 hours, enter low alarm status and minimum temperture recorded by the continuous monitoring
<0.5°C alarm device
Alarm time or OK
Minimum °C
Initials:
91
City/Municipality:
Health center:
5.5.2 Steps in Completing the Temperature Monitoring Chart
a. Accomplish one temperature monitoring chart for each of the cold chain equipment at
the start of each month.
b. Enter the name of the health facility where the equipment is located and the month
and year when the temperature recording was taken
c. Identify the brand and serial number of the equipment.
d. Read the temperature first in the morning and put a dot at the leftmost part of the line
corresponding to the reading column of date when the reading was made.
e. Read the temperature again in the afternoon prior to departure and put another dot
at the rightmost part of the line corresponding to the reading column (same used for
recording the morning temperature) of date when the reading was made.
f. Connect the dots to plot the temperature recording.
g. Record other information in case of any equipment failure and carry out appropriate
action immediately.
h. Record the name of the staff responsible for reading the temperature daily.
Tables 21 and 22 summarize the key action points in case of fluctuations in normal
temperatures for refrigerators and freezers.
TABLE 21.
Action Points for Cold Temperature Reading Description
Rooms and Vaccine
Temperature between Normal situation.
Refrigerators +2°C and +8°C
No action necessary.
Temperature at or Vaccine at risk.
below 0°C
Take immediate action to correct the low temperature
and ensure that the problem does not arise again.
Do a Shake Test to establish if vaccine has been
frozen.
Submit a report.
Temperature between Check cause.
+8°C and +10°C
No further action is necessary if there has been a
temporary power failure.
Check that the refrigeration unit is working.
Take appropriate action if the temperature is outside
the normal range.
Temperature above Vaccine at risk.
+10°C
Immediately implement the approved contingency plan
and submit a report.
Temperature mapping may also need to be carried out in spaces without active
temperature control. A mapping study establishes the temperature distribution within the
zone being mapped and locates hot and cold spots. The data collected using the Sensor
Data Recording Sheet (Annex 13) provide an essential source of information to ensure that
all vaccines are correctly stored within their labelled temperature range(s). Mapping may
also be used to identify zones where remedial action is needed.
Following the commissioning stage temperature mapping exercise, the procedure should
be repeated, at least once every three years and / or whenever significant changes are
made to refrigeration equipment, control systems or the loading conditions in the room
such as repair of cold chain equipment, replacement of broken parts or renovation of the
cold room.
No definitive standard exists for the number of sensors required to map a three
dimensional space. The placement of sensors described may have to be modified to suit
actual site conditions.
• In three planes in each direction (top to bottom, left to right, front to back) fully
covering the places where vaccines and other cold chain products will be stored;
• At points where there are known to be high heating or cooling loads;
• A minimum of 16 distribution sensors positioned as shown in Figure 18 and described
in Table 23 (the blank form is found in Annex 14), where the sensors must not be in
contact with the room enclosure;
• More than 16 sensors may be needed for larger rooms, with the sensors placed no
more than six meters apart horizontally or vertically; and,
• Additional distribution sensors placed next to the refrigeration unit control sensors
and next to any alarm sensors or temperature recording device sensors.
All testing equipment must have valid and current calibration certification against US
National Institute of Standards and Technology (NIST) or equivalent standards.
Step 1: Room temperatures are stabilized following Test 1. Room should be empty and the
door closed throughout the test.
Step 2: Run the installation for 48 hours. Record the total compressor running hours over
the test period. Following the procedure described above, record internal and external
temperatures and evaporator and condenser temperatures.
Step 3: From an analysis of the logger data, establish the maximum temperature
differences in the room and the location of any cold or warm spots.
Acceptance criteria: All recorded temperatures remain within the range of +2°C to +8°C for
cold rooms or –15°C to –25°C for freezer rooms for the entire duration of the test.
Each type of vaccine and syringe has a different packaging. Volume per dose refers to the
volume occupied by each dose of vaccine, including its secondary packaging. It is usually
presented in cubic centimetre per dose (cm3/dose).
As some vaccines vary in types of preparation, it is important to know the size of these
packages to properly estimate storage requirements. For example, a 20-dose vial HepB
vaccine will have a 2.5 cm3/dose packed volume, while a single-dose HepB vaccine will
have an 18 cm3/dose packed volume. The volume per dose of each vaccine type may be
found in the WHO Guidelines for International Packaging and Shipping of Vaccines.
Using an incorrect volume per dose in your calculations could have a serious effect on your
vaccine storage requirements.
It is essential to estimate the total storage volume of vaccines in order to determine if the
cold chain storage capacity is sufficient.
Cold storage capacity is adequate if the total available space of the all functional cold
chain equipment (cold rooms, refrigerators and freezers) is greater than or equal to the
required vaccine storage capacity for a specified period of time.
5.7.2.1 Using the Pack Volume per Dose and the Annual Dose Requirement
This is the manual method for calculating the required vaccine storage capacity and
the refrigeration storage capacity requirements. By filling in the values in the worksheet
in Annex 15 the required vaccine storage capacity can be calculated as shown in the
following example.
Table 24a and Table 24b provide guidance in using the tool for estimating total storage
volume required for vaccines.
• Diluents’ storage space inside the cold chain should be considered when calculating
for storage at the service delivery point. Diluents do no need refrigeration at the
higher level stores.
• If there is an upcoming supplemental immunization campaign, the vaccine to be used
must be included in the computation for the quarter it is expected to be delivered.
• Some vaccines may be supplied in different preparations (such as single dose Td and
multi-dose Td). The required storage volume must be calculated separately for each
type of preparation.
• Additional calculation is needed to estimate the number of ice packs required and the
refrigerator space needed to freeze them. The same calculation principle applies for
ice packs.
TABLE 24a.
Sample Estimation of Total Required Storage Volume for Vaccines
Another useful tool developed by WHO that can be used to estimate the required storage
volume per vaccine type is found in Annex 16. Once the total storage volume per vaccine is
known, data can be entered into the worksheet in Annex 17, which will help determine the
total storage volume required to keep all of the vaccines.
Implementing the bundling policy at the lower level stores requires that adequate safe
injection equipment be made available to administer the vaccines. The safe injection
equipment, stored in ambient temperatures in dry storage, can occupy a large volume.
Adequate space must be allocated for these items. Annex 18 provides a simple tool to
estimate storage requirements for safe injection equipment.
A simple tool to determine net storage capacity of cold room is available in Annex 20.
1. Sketch a floor plan of the walk-in cooler, walk-in freezer or dry stores specifying
lay-out, position of evaporator units, door(s) and shelving arrangements. Record the
following dimensions in centimeters as shown in the layout (Figure 19):
• Measure and record the L (length), W (width) and H (height) of the walk-in cold
room or freezer room
• Measure and record the l (length), w (width), t (thickness of shelves), b (distance
from floor to bottom shelf), and n (number of shelves).
2. Calculate the gross volume of cold room:
Gross Volume = l x w x h
5.8.2.1 Determining Storage Capacity based on Information from the PQS Catalogue
The manual that goes with the WHO PQS-compliant vaccine refrigerators and freezers
provides information on the gross and net vaccine storage capacity. It is a reliable source
of information about the capacity of refrigerators and freezers, including information on
installation, maintenance, and other basic information about the equipment.
Immediately record the necessary information in the cold chain inventory record (Annex
21) every time the facility receives new cold chain equipment. Keep a compilation of this
information brochure for future reference. Table 27 shows an example of a documentation
of WHO pre-qualified cold chain equipment storage capacity based on the PQS catalogue.
A B C D E F G H I
Ice-lined Electrolux TCW E3/24-M 169 1 169
refrigerator (ILR) 1152
Ice-lined Electrolux TCW E3/98-M 37.5 1 37.5
refrigerator) 1990
Freezer Electrolux FCW 200 144 1 144
If the gross or net storage capacity is not known, manual calculation of the storage
capacity should be done. The calculation of the vaccine storage net capacity of a front
opening (Figure 20) and top opening refrigerator and freezer (Figure 21) uses the formula
for determining net volume in liters as shown in the box.
The utilization factor for a freezer is 67% (0.67) while 50% (0.5) for a refrigerator. Higher or
lower figures may be appropriate in specific circumstances.
Required:
1) Freezer storage volume
2) Refrigerator storage volume
Solution:
1) Freezer storage volume= (50 x 80 x 60)/1000 x 0.67 = 161 liters
2) Refrigerator storage volume= (100 x 80 x 60)/1000 x 0.50= 240 liters
Required:
1. Storage volume if used as a freezer
2. Storage volume if used as a refrigerator
Solution:
1. If used as a freezer, storage volume
= (80 x 90 x 100)/1000 x 0.67 = 482 liters
2. If used as a refrigerator, storage volume
= (80 x90 x 100) x 0.50 = 360 liters
Use the decision tree in Figure 22 as guide when selecting the most appropriate energy
source for vaccine refrigeration equipment.
The decision tree starts with a question on the availability of electricity (i.e., the number
of hours per day, if not available the whole day) in the intended area. Possibilities to be
considered are the following:
• If electricity is available for only about 3 hours/day, the following options can be
considered: 1) solar direct drive vaccine refrigerator; 2) solar-powered refrigerator
with battery storage; 3) long-term passive refrigeration device; and 4) liquid
petroleum gas fueled refrigerator.
• If electricity is available for at least 4-7 hours/day with more than 20 hours of power
cuts, an ice-lined refrigerator with adequate hold-over time or solar-powered
refrigerator can be used.
• If electricity is available for 8-20 hours/day with no more than 20 hours/day power cuts,
a standard ice-lined refrigerator with or without freezing compartment can be used.
• If electricity is available for 21-24 hours/day with power cuts of not more than 4
hours, an electric compression refrigerator laboratory-tested to PQS standards can
be used.
On average,
how many hours
a day is grid/generator
electricity
available?
0 to 3 4 to 7 8 to 20 21 to 24
No No
Is a Use standard
solar service Use electric
provider available
No ice-lined
compressor
refrigerator with/
or can one be refrigerator/
without freezing
established? freezer* ‡
compartment
Yes
Is battery-
Is solar Is passive
direct-drive No powered No refrigeration
solar
technology technology
technology
suitable? suitable?
suitable?
Yes Yes No No
Use battery-
Use long-
powered solar Consider liquid
Use solar direct- term passive
refrigerator or petroleum gas
drive refrigerator refrigeration
refrigerator- solutions
device
freezer
• Never store vaccines with non-vaccine products such as medicines and laboratory
reagents and with any laboratory specimen.
• Vaccines must always be properly labelled and stored at the recommended
temperature ranges. Labels should be visible at all times.
• Keep Penta vaccines, TT, Td, Hep B, Rota and PCV vials on the middle shelf and away
from the evaporator cooling surface.
• Keep OPV, MR, MMR, JE and BCG vials on the shelves close to the evaporator surface
as shown in Figure 24.
• Place sufficient ice packs on the lowest shelf of the compartment prior to moving to
the freezer compartment.
• Vaccines and BCG/Measles diluents from the same manufacturer must be stored at
the same temperature at the service delivery point (health center, RHU or clinic)
• Arrange vaccines and diluents to ensure good air circulation. Maintain at least 2 cm
of space between vaccine cartons.
• Always use the manufacturer’s vaccine baskets for storing vaccines inside the ice-
lined refrigerators as shown in Figure 25 and follow the manufacturer’s instruction on
how to properly and safely arrange vaccines in the baskets.
• For chest refrigerators without vaccine baskets, follow the recommendations on
vaccine arrangement as shown in Figure 26.
• Keep OPV, BCG, MR, MMR vials on the lower section of the refrigerator.
• Keep Penta vaccines, TT, Td, Hep B, Rota and PCV vials in the upper basket.
• Pack BCG and Measles diluents near the Penta, TT, Hep B vials.
FIGURE 24.
Vaccine Arrangement in a Front Opening Refrigerator
Freezer compartment
(if provided)
Store icepacks upright to
Freezer compartment avoid leaks
on left
Refrigerator compartment
+2C to +8C
Freeze-sensitive vaccines
on middle shelf. Closer
expiry date at front.
FREEZER COMPARTMENT
(some models). KEEP LID
CLOSED.
ICE-BANK COMPARTMENT
(some solar direct-drive
models). DO NOT remove
ice-packs.
FIGURE 26.
Loading Vaccines in a Top-Opening Refrigerator without Baskets
Icepacks in freezing
compartment
This chapter aims to develop the knowledge and skills of health workers on:
Chapter 6 | Distribution and Transport of Vaccines and Safe Injection Equipment 115
6.1 Supplies Distribution Plan
Adequate and timely distribution of the vaccines and injection devices is critical to ensure
that all level of health facilities providing immunization services have vaccine supplies
sufficient to cover the eligible population within their catchment area. Any delay in the
distribution of vaccines or error in calculating vaccine needs may potentially result in stock-
outs and missed opportunities for the intended recipients.
The DOH NIP, in coordination with the RITM SDD, are responsible for preparing the
vaccine allocation and distribution plan. The plan is prepared at the beginning of
the first quarter of each year. The plan is reviewed and adjusted based on inventory
reports and vaccine requirements at sub-national levels, such as during supplemental
immunization or outbreak response activities. The DOH NIP and RITM SDD also jointly
monitor vaccine wastage and utilization quarterly reports submitted by the different
vaccine distribution facilities.
Copies of the vaccine allocation and distribution plan are provided to the different DOH
Regional Offices, which then provide copies to the different PHOs and CHOs. Table 28
shows a sample of a vaccine and immunization supplies distribution plan. The template is
available in Annex 22.
TABLE 28.
Sample Form of Vaccines and Immunization Supplies Distribution Plan
VACCINE ALLOCATION
AND DISTRIBUTION PLAN
The following are recommended actions to be undertaken in every level of cold chain store
before and during transport of vaccines.
Chapter 6 | Distribution and Transport of Vaccines and Safe Injection Equipment 117
6.3 Passive Containers (Cold Box
or Vaccine Carrier)
The WHO prequalified passive containers (Figure 27) are robust, insulated, and reusable
cold chain equipment used for transporting vaccines from place to place. Each comes with
WHO prequalified ice packs. The ice packs provide the thermal mass needed to maintain a
safe storage temperature range for the required transport period. Cold boxes have hinged
lids while vaccine carriers have generally separate lids, although hinged lids are optional.
FIGURE 27.
Samples of Vaccine Transport Box and Vaccine Carrier and the Proper Arrangement of Ice Packs
1. Ensure that the inner compartments of the transport box and vaccine carrier are
clean and free of dust and foreign objects.
2. Line the interior of the cold boxes and/or vaccine carriers with conditioned ice packs or
cool water-packs following the manufacturer’s instructions found on the inside of the
lid (Figure 28).
3. Put an electronic freeze tag indicator with the vaccines if conditioned ice packs are
used.
4. Put vaccines and diluents in a plastic bag in the middle of the cold box or vaccine
carrier to protect them from damage (Figure 29).
5. Place a foam pad in the top of the container if a vaccine carrier is used.
6. Close tightly the lid of the cold box or vaccine carrier.
Rural Health Units, Health Centers, and clinics comprise the last level of the cold chain
system where most of the vaccines are administered. At these levels, vaccines are handled,
transported and protected from heat and light in order to ensure efficacy and potency.
Health staff should have the knowledge and skills in arranging vaccines in a vaccine
carrier and cold box to maintain ideal vaccine temperature.
FIGURE 28.
How to Load a Vaccine Carrier
Chapter 6 | Distribution and Transport of Vaccines and Safe Injection Equipment 119
FIGURE 29.
Five Steps in Preparing a Cold Box for Vaccine Shipment
5
Put the ice packs
on top.
Put the vaccines in
the cold box.
• Place the ideal number of conditioned ice packs in the cold box or vaccine carrier.
• Keep the cold box or vaccine carrier in the shade.
• Keep the lid tightly closed.
• Use the foam pad to hold opened vials during immunization sessions as shown in
Figure 30.
FIGURE 30.
Use of Foam Pad to Secure Opened Vaccine Vial in a Vaccine Carrier
Chapter 6 | Distribution and Transport of Vaccines and Safe Injection Equipment 121
Chapter 7
PREVENTIVE
MAINTENANCE
OF COLD CHAIN
EQUIPMENT
CHAPTER 7
Preventive Maintenance of
Cold Chain Equipment
This chapter will enhance the knowledge and skills of health staff to:
This section outlines the basic guidelines for performing preventive maintenance of cold
chain equipment based on type of equipment and frequency.
This guidance is intended for cold chain technicians at the national, regional and some
provincial/city level health facilities with walk-in cold rooms.
• Check and record cold chain equipment temperatures twice daily: once in the
morning and once in the afternoon.
• Listen for unusual noise(s) coming from the cooling equipment. Contact the
responsible maintenance personnel if you are unable to resolve the problem.
• Check inside the room to ensure that airflow from the evaporator is normal and not
blocked and the evaporator fan is running quietly.
• Ensure there is no water on the cold room floor caused by blocked drainpipe.
• At the end of the day, ensure that all lights in the room are switched off; that nobody
is left inside the room; and, the door to the room is closed and locked.
• Check the room enclosures for any signs of rust at the bottom of the panels, any
evidence of movement from internal and external panel joints or any significant ice
build-up on the panels.
• Check if locks are working properly and all keys are accounted for.
• Check the doors to ensure the internal safety release handle is working properly. This
must be done in the presence of a colleague who will open the door in case it cannot
be opened from the inside.
• Check the freezer room pressure release vent for ice-build up, resulting in difficulty
opening the door.
• Check if the freezer room heater door is working properly.
• Check the strip curtain and replace if damaged.
• Check the spare parts inventory to ensure the stock of spare parts for the cold and
freezer room is adequate. Request for replenishment of levels are low or there are
missing parts from the inventory.
The following are preventive maintenance guidelines for health staff at the lower vaccine
stores using electric compression refrigerators and freezers.
• Check and record equipment temperatures twice daily: one in the morning and one in
the afternoon.
• WHO/UNICEF PQS compliant refrigerators have non-adjustable thermostats fixed at
the correct temperature. If the temperature is not in the correct range, contact your
supervisor.
• Avoid frequent adjustments.
• Do not adjust the thermostat to a higher setting when a new vaccine delivery arrives.
This could freeze the vaccines.
• Do not adjust the thermostat on an ice-lined refrigerator once the thermostat has
been correctly set and taped in position.
• Do not adjust the thermostat when the power is restored after a power outage.
• Ensure that the condensing and cooling unit is clean. Remove any dirt or dust with a
soft brush.
• Clean the outer part with a damp cloth.
• Clean the lid or door gasket with soap and water. Check for damage.
• Check if the lid closes tightly.
• Defrost the unit whenever ice build-up on the inner lining is thicker than 5mm. First
transfer the existing vaccines to another refrigerator, cold box or vaccine carrier.
• If vaccines are at immediate risk, protect the vaccines by temporarily moving them to
another location within the store.
• If the equipment is repairable, carry out repairs within seven days.
• If repairs will not be cost-effective, request a replacement unit as soon as possible.
Dispose of the damaged unit by first removing the doors or lids from refrigerators or
freezers to prevent the children from becoming trapped. Recycle refrigerants.
• Update the spare parts inventory and order replacements as needed.
The following are preventive maintenance guidelines for health staff at the lower vaccine
stores using solar-powered compression type refrigerators and freezers.
• Check and record equipment temperatures twice daily: once in the morning and once
in the afternoon.
• Check the status of the refrigerator/freezer control panel on the display.
• Remove any dirt or dust off the solar array and refrigerator/freezer unit. This reduces
the equipment’s cooling performance.
• In cleaning the solar array, follow the following steps:
1. Clean the array in the early morning or evening when the sunlight is not intense.
2. Make sure appropriate safety equipment and ladder are used, especially when
working on a high location. Do not attempt to carry out this task unless you have
the correct access and equipment.
3. Use soft cloth wet with water. Wipe gently, starting at the top and working
downwards.
4. Do not lean or stand on the solar array panels. This could cause irreparable
damage.
• Report any damage to wiring or hardware to your supervisor.
• In very dusty areas, clean the solar array on a weekly basis
• Defrost the unit whenever ice build-up on the inside lining is thicker than 5mm. First
transfer the existing vaccines to another refrigerator, cold box or vaccine carrier.
• Check the solar array shading. Ensure that solar panels are not shaded by trees,
plants, new buildings or overhead cables between 9 AM to 3 PM. If there is shading
from a newly constructed building or new overhead cables, contact your supervisor
for advice prior to any repositioning or transfer of the solar array to a different or
appropriate location. Arrange to trim or prune the shading vegetation.
• Inspect electrical cables between the solar array, charge regulator and the
refrigerator. Replace damaged cables.
• Inspect grounding/lightning protection.
Note: Report to the supervisor any problem observed in the equipment. In case of
equipment failure and/or long power interruption, act according to emergency
plan.
• If vaccines are at immediate risk, protect them by temporarily moving them to another
location within the store.
• If the equipment is repairable, repair the refrigerator or freezer within seven days.
• If repairs will not be cost-effective, request a replacement unit as soon as possible.
Dispose of the broken unit by first removing the doors or lids from refrigerators or
freezers to prevent the children from becoming trapped. Recycle refrigerants.
• Update the spare parts inventory and order replacements as needed.
7.1.4 Preventive Maintenance Guide for Cold Boxes and Vaccine Carriers
Vaccine carriers and cold boxes must be cleaned and dried after use. If they are left wet
with their lids closed, they will become moldy. Mold may affect the cold boxes’ and vaccine
carriers’ seals’ tight fit. If possible, store cold boxes and vaccine carriers with the lid open,
when not in use.
Knocks and sunlight can cause cracks in the walls and lids of cold boxes and vaccine
carriers. If this happens, the vaccines inside will be exposed to heat. If a cold box or vaccine
carrier wall has a small crack you may be able to repair it with tape with strong adhesive
until you can get a replacement.
All cold chain equipment such as ice-lined refrigerators, walk-in freezers, walk-in cold room
and other types of refrigeration unit used for storing vaccines should have an automatic
voltage regulator (AVR). This will protect the unit from power supply fluctuations as well
as prolong the service life of the equipment.
Every morning, upon arrival in the cold chain facility, the staff in-charge should carry out
the checks described below for each type of voltage regulator.
• Make sure the correct type of unit is connected to the refrigerator or freezer.
• Check that the input and output indicator lights on each of the units are lighted
correctly.
• If the unit is defective, replace as soon as possible.
• Check that the 3-phase meter is reading +-400 volts +-1% (396-404 volts).
• Check that the three individual phase meters on the lower panel are all reading 230
volts +-1% (228-232 volts); If not, contact the responsible maintenance personnel.
• Check that all three red, yellow and green output and input phase indicator lights are
on; if not, contact the responsible maintenance personnel.
• Listen to the unit. If there is a clattering sound, contact the responsible maintenance
personnel.
Defrost the refrigerator when ice becomes more than 0.5 cm thick, or once a month,
whichever comes first.
1. Defrost the unit whenever ice build-up on the inner lining is thicker than 5mm. First
transfer the existing vaccines to another refrigerator, cold box or vaccine carrier.
2. Remove the most heat-sensitive vaccines and transfer them to a cold box lined
with frozen ice packs or to another vaccine refrigerator or freezer.
3. Remove the freeze-sensitive vaccines and diluents and transfer them to a cold
box lined with cool water packs or conditioned ice packs or to another vaccine
refrigerator.
4. Transfer any frozen ice packs to a cold box or to another freezer.
5. Transfer any cool water packs to a cold box or to another refrigerator.
6. Turn off the power supply of the refrigerator or freezer.
7. Leave the lid or door open and wait for the ice to melt. Do not try to remove the ice
with a knife or other sharp object. This can permanently damage the evaporator
pipes and the unit’s cooling ability. To speed up the defrosting process, place a pan
of hot water inside and close the lid or door.
8. Clean and dry the interior of the refrigerator.
9. Turn on the power again. When the temperature in the main section of the
refrigerator falls to +8°C return the vaccines, diluents, and the cool water packs.
10. When the temperature in the freezer falls to -5°C, return the heat-sensitive
vaccines and ice packs.
There are three possible causes for defrosting cold chain unit more frequently:
This chapter will enhance the knowledge and skills of health staff to:
• Ensuring that all affected vaccines are stored within the recommended storage
temperature of +2°C to +8°C as soon as possible;
• Identifying alternative locations where vaccines can be safely stored or where ice can
be obtained at short notice;
• Preparing and maintaining at least two emergency response plans;
• Posting emergency contact details of key personnel at locations where they can be
accessed at all times;
• Clearly describing initial and follow-up actions that can be implemented both inside
and outside of working hours; and,
• Reviewing the plan at least once a year to ensure that it is still valid.
Sample scenarios requiring activation of contingency plan and suggested actions are
found in Annex 24.
• Find someone in your facility trained to conduct simple troubleshooting and repair of
the unit. If none, request support from the next higher level.
• If required repair work is minor, transfer the vaccines to another functional cold chain
equipment or in cold boxes or vaccine carriers.
• If major repair work is needed, transfer the vaccines to functional cold chain
equipment. Look for available vaccine storage equipment nearby if more temporary
storage space is necessary while the problem is diagnosed and repair is in progress.
• Check if the person responsible for the transport of vaccines has the knowledge on
how to protect the vaccines from the ambient temperature during transport delay
and breakdown repair. If not, seek support from a knowledgeable/trained staff.
• Check the cold life of the transport box
• Identify available refrigerator along the route where vaccines can be temporarily
stored if needed.
• Identify available supplier of ice along the route and use them as needed to keep the
vaccines cold (be careful not to freeze the freeze-sensitive vaccines).
• Prepare a contingency plan aligned with the over-all organizational evacuation plan.
• If the event is predictable, as in the case of flooding, immediately transfer all vaccines,
including cold chain equipment (if possible) to a higher, safer location.
• Do NOT try to save the vaccines during a fire, flood or earthquake in progress. Avoid
the risk of getting hurt or being trapped in the vaccine store.
• Do NOT enter the vaccine store after the disaster unless it is declared safe by
authorities.
• Immediately identify alternative cold storage equipment to safekeep the vaccines that
remained potent.
• Any vaccine damaged or potentially contaminated as a result of the disaster should
be recorded and reported as wastage according to national policy.
• A vaccine supply replacement order should be immediately accomplished to prevent
disruption of routine immunization services or any immunization response activity
following disasters, as necessary.
• In case of fire, investigate the cause of fire and carry out necessary intervention to
avoid a similar situation in the future.
• Check if the proper lead time has been followed in making the request for vaccines
and injection equipment.
• Check if the request was submitted based on the agreed distribution plan.
• Ensure that there is sufficient cold storage space for the newly arrived vaccines.
• Document and report the delay after carrying out the usual vaccine arrival
procedures.
• Determine if the store has a supply of the vaccine needed for the immunization
response activity.
• Check if the supply is adequate to respond to the outbreak without compromising
routine immunization activities. If supply is inadequate, promptly submit a request as
needed.
• Determine if the existing vaccine storage capacity, including transport boxes and
vaccine carriers, and ice packs are adequate to store the quantity required for
outbreak response immunization.
• Maintain a communication link to the higher cold chain level for equipment, supply
and personnel back-up.
• Ensure that there is an updated plan to cope with epidemic emergencies, taking into
account the needed personnel, fuel and transport needs.
1. WHO Vaccine Management Handbook, How to Use Passive Containers & Coolant-
Packs for Vaccine Transport and Outreach Operation, VMH-E07-02.1, WHO/
IVB/15.03
2. WHO Vaccine Management Handbook, How to Monitor Temperatures in the
Vaccine Supply Chain, VMH-E02-01.1, WHO/IVB/15.04
3. WHO, EPI, Immunization Supply Chain & Logistics, WHO/IVB/14.05
4. WHO Policy Statement: Multi-Dose Vial Policy (MDVP), WHO/IVB/14.07
5. WHO/UNICEF PQS Devices Catalogue, WHO/IVB/11.08
6. EVM Standard Operating Procedures, WHO/IVB/09.5
7. WHO EVM Assistant Tool, WHO/IVB/09.xx
8. WHO Training for Mid-Level Managers, Cold Chain & Safe Injection Equipment
Management, WHO/IVB/08.01
9. DOH, EPI, Cold Chain and Logistics Management Manual/4th Edition/05
10. WHO Immunization in Practice: The Vaccine Cold Chain WHO/IVB/04.06
11. WHO EPI Safe Vaccine Handling, Cold Chain and Immunizations, WHO/EPI/
LHIS/98.02
12. WHO Guidance Note: Vaccine Diluents, WHO/IVB/15.08
13. TechNet 21, Selecting a Suitable Energy Source
14. WHO PQS Quality Assurance Protocol. Cold Rooms and Freezer Rooms: Guidance
Section. WHO/PQS/E001/CR-FR01-VP2.3
15. VVM Getting Smarter, U. Kartoglu
16. WHO EVM Model Standard Operating Procedures Guide, V3 June 2013
17. Disposal of Mass Immunization Waste without Incineration, prepared of Health
Care Without Harm (HCWH), Jorge Emmanuel, Merci Ferrer and Faye Ferrer
18. Temperature Monitoring Device: An Overview. PATH. https://www.path.org/
publications/files/TS_opt_handout_tmd_overview.pdf