1. Challenges in
Cold Chain Management
Universal Immunization Program (UIP) and
Supplementary Immunization Activities (SIA)
Dr Pritu Dhalaria
Director Immunization PATH

2. Evolution of UIP
1978 - Expanded Program of immunization (EPI)
1983 - TT immunization of Pregnant Women
1985 - Universal Immunization Program (UIP) For 6 VPDs
1990 -Vitamin A Supplementation was added; UIP and
ORT universalized in all districts
1992- CSSM
1997- RCH-1
2000- Immunization Strengthening Project (2000-03)
2005- NRHM and RCH II

3. UIP - An Overview
• Largest public health interventions, largest in the world
• Target 27 million infants and 30 million pregnant
women every year
• Against the 6 Vaccine Preventable Diseases (VPD)
(Tuberculosis, Polio, Diphtheria, Tetanus, Pertussis, & Measles)
• Since 2006, Hepatitis B and Japanese Encephalitis
vaccines introduced in selected districts and states
• India is close eradicating Polio transmission
• Measles second opportunity is being introduced – SIAs /
RI
• Introduction of the Pentavalent vaccine in the UIP may
also be on the cards

4. SIAs in Recent Times
• Pulse Polio (Polio SIAs) under Polio Eradication
Initiative
• Japanese Encephalitis (JE) Vaccination Program
• Measles SIAs
Maintaining Cold Chain remains
one of the big challenge

5. Cold Chain - Definition
The 'cold chain' is a system of storing
and transporting vaccines at
recommended temperatures from the
point of manufacture to the point of
use - WHO
http://www.who.int/countries/eth/areas/immunization/epi_logistics/en/index1.html

6. Cold Chain System
• High coverage is important, but it is not enough!
• Was potent vaccine administered safely and efficiently
in a timely manner before exposure to disease?
• All Vaccines lose potency on
exposure to heat above +80 C
• Some Vaccines lose potency
when exposed to freezing
temperatures
• The damage is irreversible
Colder is not necessarily better!!

7. Essential Elements of Cold Chain
The cold chain is the combination of people,
equipment and established processes.
processes.
• PERSONNEL to organize and manage vaccine
distribution.
• EQUIPMENT for storage and transport of vaccine.
• PROCEDURES to ensure that vaccines are stored and
transported at appropriate temperature
• MAINTENANCE OF EQUIPMENT
• MONITORING

8. Cold Chain System Needs to be Robust
to Support Various Newer Vaccines
Current RI Vaccines for Potential New
Vaccines SIAs Vaccines
 BCG Monovalent OPV1  Pentavalent1 Vaccine
OPV Monovalent OPV3  Pneumococcal Vaccine
Measles  Measles  Rota Virus Vaccine
DPT  JE, etc.
Hepatitis B
Tetanus Toxoid
1. Pentavalent includes Hib, diphtheria, pertussis, tetanus, Hep B
Hib, pertussis,

9. Impact of New Vaccines on Cold
Chain (Pentavalent, MR, PCV & Rota)
Pentavalent, Rota)
0 50 100 150 200 250 300 350
TV (BCG, DPT,TT,MSL,OPV) 45.6
TV – Traditional Vaccines
Cold chain Space
TV+ Penta 33.6 19.8 required per cm3
TV+ Penta+ MR 33.6 19.8 3.1
TV+Penta liquid+Pneumo(PFS) 33.6 19.8 197
TV = Traditional Vaccines
TV +Penta liquid+Pneumo(2DV) 33.6 19.8 22
TV +Penta liquid+Rota Lyo with Diluent 33.6 19.8 222
TV +Penta liquid+Rota Liquid 33.6 19.8 255
TV (bcg, dpt,opv, msl, tt) TV + Penta TV + Penta + MR Pneumo (PFS)
Pneumo (2 dose vial) Pneumo Uniject Rota Lyo GSK with Diluent Rota Liquid MSD

10. Review of Cold Chain
System in India

11. Vaccine Stores in India
Store Level Numbers Equipments Stock Purpose
GMSDs 4 WIC, WIF & 3 Buffer & Supply for NE
Concrete Cold months States, UTs , J& K
Rooms
State Vaccine Stores 39 WIC, WIF Buffer & Supply to
Divisions/Districts
3
Divisional Vaccine 123 WIC, WIF, DF months Buffer & Supply to
Stores (large), ILR (large) Districts
District Vaccine 618 DF (large), ILR 3 Buffer & Supply to
Stores (large) months Blocks
CHC 4045 DF ( small) & ILR 1 Supply to Session Sites
PHC 22394 (Small) month
 DFs are used for freezing of vaccines / Ice packs besides storage of OPV
 All RI vaccines are kept in ILR at PHC/CHC.
Immunization Division, MOHFW, GoI.

12. Key Cold Chain Issues
• Most cold chain rooms are old & substantial up
gradation is required*
• A large part of the cold chain equipment in the country
is currently operating on obsolete CFC refrigerant
(aging cold chain equipments)*
• Cold chain management is poor in some places
(including private practices), particularly for
temperature recording and risk of freezing the freeze-
sensitive vaccines**
• Inadequacy of trained manpower with essential
qualifications at every level
*www.mohfw.nic.in/…/JS_AMP_Presentation_13Apr2010.ppt accessed on 11th Nov.2010
**www.mohfw.nic.in/nrhm/Presentations/Bhopal…/immunization.ppt accessed on 11th Nov.2010

13. Cold Chain Issues in Field
Untrained Manpower handling the cold chain
• Cold chain handlers are often personnel who lack the
capacity, skill and dedication, generally too old for field
work/office work. Eg. LHVs, senior ANMs
• Comprehensive and hands on training required
• No alternate plan in case the designated Cold chain
handler is on leave
• Trained manpower often transferred and replaced
• Medical officers often themselves lack knowledge on
cold chain maintenance, difficult for them to supervise
• Interpretation of VVM by field workers remains a big
challenge

14. Vaccine Vial Monitor - Interpretation
Earlier
Current

15. Cold Chain Issues in Field…
Inadequate maintenance of cold chain equipment**
• High cold chain sickness rate#
• Long response time to breakdown of equipment
• Not enough cold chain engineers / refrigerator
mechanics in states and districts
• Lack of adequate training
• Lack of adequate equipments
• Voltage fluctuation, equipments not attached to
stabilizers, lack of proper wiring and earthing
• Improper cleaning and defrosting of equipment
#The proportion of cold chain equipment out of order at any point of time.

16. Cold Chain Issues in Field…
Poor Monitoring of the Cold Chain
• Slackness in the field regarding cold chain maintenance
by ANM and MPW male
• Poor supervision, monitoring, contingency plan
• Condemned equipment not disposed off timely
• Shortage of accessories like thermometers, stabilizers,
equipment stands, freeze tag, etc.
• Inadequate recording and documentation
– Power cuts / generator running / defrosting not documented
in log books
– Temperature charting not done meticulously /regularly
There is a saying “if it is not documented , it never happened!”

17. Challenges for Cold Chain
System during SIAs

18. Challenges related to SIAs
• Immunizing large population at one go
• Bulk requirement of vaccine and logistics causing
sudden and excessive burden on cold chain system
• Extra pressure on overburdened health personnel
• Reduction of focus due to other health programs
• Intensive planning and training for campaign
• Communication challenges
• Extra funding
• Waste disposal and safe injection practices

19. Cold Chain Space for SIAs:
(Stress for Cold Chain System)
Cold Chain faces stress during SIAs on following issues:
• Needs to suddenly accommodate large volume
• Storing the RI vaccine poses a big challenge
• Requirement for Ice pack freezing increases
• Transportation to session sites poses a big challenge,
especially in absence of adequate number of cold
boxes / vaccine carriers.
• Vaccine delivery system is often inadequate,
unreliable and no proper plan for AVD (Alternate
Vaccine Delivery System)

20. Shortage of Equipments
Refrigerators and freezers not
timely repaired

21. Transport challenges
Large Volumes to transport
Insufficient cool boxes for
vaccine transportation
Loose vials take less
space, but stock
managements becomes
impossible

22. Vial Protection and Arrangements
Vials not put in plastic bag; exposed to contaminated melt
water from icepacks.

23. Vial Protection and Arrangements…
Different Batches Mixed Mixed Vaccine Vials with
with Missing Labels Missing Labels

24. Vial Protection and Arrangements…
mOPV 1
tOPV
Presence of all 3 types of OPV at Planning units long after
completion of SIA rounds
Stage 3
vaccine
Return all monovalent OPV to DHQ after the round.
mOPV 3

25. Vaccine Delivery
Vaccine carrier lying in area Vaccine left in carrier after
5 days after SIA completed the activity

26. Handling Equipments
Freezing Ice packs: Overfilling Deep
Freezer damages equipment

27. Key Steps for Improvement in Cold
Chain Performance during SIAs
• To increase available cold chain space as per new
requirement
• Effective utilisation of available cold chain space
• Assess Cold chain space requirement for storage of
vaccine and diluents
• Assess Cold chain space requirement for freezing and
storage of Ice packs

28. Cold Chain System Assessment
(Corrective Measures)
• Vaccine arrival procedures
• Stock management
• Vaccine storage temperatures
• Effective vaccine delivery
• Cold storage capacity
• Correct diluents use for freeze dried vaccines
• Buildings, cold chain equipment and transport
• Effective Vaccine Vial Monitor (VVM) use
• Maintenance of cold chain equipment and
• Vaccine wastage control

29. Planning of Cold chain Space
• High expertise is needed on micro planning of cold
chain
• Extra space for the diluents also needs to be taken into
account
• Calculation of dry Cold chain storage space is
imperative for storing syringes, hub cutter, etc.
• Vaccines need to be supplied for vaccines in multiple
cycles e.g State -Division, Districts- Blocks – like :50%
(Before Activity): 25% (End of 1st Week): 25% (End of
2nd Week of Campaign).
• Use of WIF /DF for storage of OPV/Measles vaccine
only during campaigns/Catch up.

30. Planning of Cold chain Space…
• Proper Icepack freezing plan (ensuring enough space
is available for it)
• Use of Cold Box for storage of vaccine and storing
freeze icepacks during campaign
• Storage of diluents in the Cold Box with conditioned
Ice Packs 24 hrs before immunization
• Use cold chain space of near by PHC and District
vaccine stores
• Identification of Ice factory with prior mutual
agreement for storage of vaccine with clear space / Ice
pack frezing

31. Dealing with Shortage and repair of
equipments
• Identify all repairable equipment
• Repair of equipment and proper maintenance
• Making spare parts available : local procurement
• Install and use of WIC/WIFs on a priority basis
before campaign.
• Installation of all new ILRs , DFs and Solar equipment
on war footing
• Expansion of cold chain points beyond Block PHCs
• Quick assessment and Planning for installation

32. Vaccine Delivery System
• Transportation of the vaccines to the site incase the
extra vaccine is required
• Availability of adequate vehicles and manpower for
supplying vaccines, ice packs or diluents where ever
there is shortage of supplies.
• Need for proper management/ tracking of the unused
vials which are returned from the Immunization
sessions
• Contingency plan needs to be such that there is a
prompt supply of any deficit of the stock in terms of
vaccines or the ice-packs.

33. Cold Chain System in Campaign
• Use of generators for continuous power supply of all
the electrical equipment
• Training of cold chain handlers after needs
assessment
• Proper record keeping for temperature maintenance
and vaccine distribution
• Proper recording and reporting
• Effective monitoring and supervision

34. Summary
• Effective utilization of cold chain space
• Regular assessment of cold chain systems to take corrective
measures
• Identify repairable equipment and ensure proper maintenance
• It is essential to use generators for ensuring continuous supply
of power
• Comprehensive training of cold chain handlers is mandatory
And lastly to develop and implement an effective monitoring and
supervisory plan to ensure smooth functioning of the cold
chain system

35. Thank You
Dr Pritu Dhalaria,
MBBS, DCM, MD.
Director Immunization [India]
Project Director
• Japanese Encephalitis
• SCLTI Madhya Pradesh
• RI Project in Mumbai Slums
PATH, India
+91-9910108830
pdhalaria@path.org
www.path.org/je