FIJI SCHOOL OF NURSING PRIMARY HEALTH CARE

COLD CHAIN SYSTEM 14th April 2010

Sr. Seini Ravea, Year 3 Manager, FSN

COLD CHAIN

The key to potent vaccine

TOPICS
 Cold Chain Equipment fridges Packing vaccines in the fridge Monitoring tools  Vaccines Sensitivity VVM vaccine vial monitor MDVP- multi-dose vial policy

OBJECTIVES
At the end of the session, students will be able to: 1. Explain the meaning and levels of the cold chain 2. State the correct range of temperature for storing each vaccines 3. Describe the cold chain equipments available in our health facilities 4. Demonstrate how to use and maintain Cold Chain Equipment. 5. Demonstrate how to position vaccines in refrigerators and the proper way of transporting vaccines. 6. State the correct VVM, MDVP and vaccine sensitivity

DEFINITION
Cold Chain: The system of transporting, storing and handling vaccines at the temperature of +2C - +8C to maintain vaccine potency from the manufacturer to the point of vaccine administration.

From Manufacturer Regional store Nadi YCS

How long is the cold chain?

National Level FPSC

Intermediate Vaccine Store

Health Centre/Nursing Station

Cold Chain Equipment Used in Health Facilities.  Fridges Absorption, Compression

(Gas, Electricity including Domestic)

    Cold Boxes Vaccine carriers Foam pads Ice packs

Vaccine Refrigerator
Compression type
 This type is operated by electricity. There is an electric motor (compressor) at the back.  The compression type has powerful cooling, approximately four times more than absorption refrigeration.  The compression type requires less maintenance.

Absorption Type RCW50EG

   This type is operated by electricity and gas. There is a heating unit at the back. This can alternatively be operated with Gas or Electrical energy. The device will not function and might be damaged if it is operated with both energy supplies simultaneously. This has two compartments; one for vaccine storage and one for ice-pack freezing and storage of icepacks (4pcs. of 0.6 liter). After setting into operation, the refrigerator needs a minimum of 24 hours to reach suitable temperature for storage of vaccines. For gas operation, the gas cylinder of 13kg should last 1 months, 45kg should last 3 months. This will vary with conditions to use (The approximate consumption rate for one day is 0.43kg)

RCW50EG
Freezer section 4 icepacks

for

Top-opening chest refrigerators and Frontopening models.

Top-opening chest refrigerators Insulation Ice-lined model Better insulated Front-opening refrigerators

Poorly insulated Available (Holdover Not available time: more than 20hrs.) (No holdover time) Less cold air is lost when the lid is opened. Awkward Cold air is lost every time the door is opened. Easy to follow EEFO.

Lid open

Access to the vaccine

COLD BOXES In addition to transport, cold box is used for temporary storage for when a refrigerator is out of order or being defrost. Health facilities need one or more cold boxes.

Foam Pad
 Use Foam pad to keep vaccine cool during immunization session.  Do not use ice pack for this purpose because the practice may freeze vaccines.

Ice-pack
 Every health facility should have minimum two sets of icepacks for each of their cold boxes and vaccines carriers. 1) one is to freeze ice-pack (reserve). 2) the other is to use in a cold box or vaccine carrier.

Cold Chain Monitoring Equipment

Health facility staff use dial or stem thermometers to monitor the temperature of refrigerators. On a dial thermometer the needle moves around the scale, pointing to plus (+) numbers when it is warmer and to minus (-) numbers when it is colder. On a stem or bulb thermometer, coloured fluid in the bulb moves up the scale as it becomes warmer, and down the scale as it becomes colder.
Thermometer

Freeze Tag Monitors

It consists of an electronic temperature. If the indicator is exposed to a temperature below 0C for more than 60 minutes the display will change from the good status into the alarm status as indicated below. The indicator is used to warn of freezing and is packed with freeze sensitive vaccines. The shelf life is five years.

General rules about refrigerators

Opening the refrigerator door raises the temperature. Before you open the door, plan what you are going to do. When you open the door, do what you have to do quickly and close the door as soon as possible. Try not to open the refrigerator door more than three times a day.

Vaccines and Cold Chain Equipment Management

There should be one person responsible for the refrigerator and the following duties: storing vaccines, diluents, and ice-packs checking and recording the temperature twice daily, even on week-ends maintaining the facilitys cold chain equipment ensuring only vaccines are stored in the vaccines fridge all health workers in a health facility, should know how to monitor the cold chain and what action to take if the temperature is too high or too low.

How to load cold chain equipment

1) 2) 3) 4) 5) 6) 7) 8) 9) Freeze and store ice-packs in the freezer compartment. Place all the vaccines and diluents in the refrigerator compartment if space permits. Keep boxes of freeze-sensitive vaccine away from the freezing compartment, fridge plate, sides and bottom of the fridge freezing may occur. Make use first box to store opened vials to use first to ensure Multidose vial policy. Only keep vials that are good for use in the refrigerator. Arrange boxes of vaccines so air can circulate between them. Keep Vaccines with VVM showing heat exposure in a box labelled use first. Use these vials first in the next session. Keep bottles of water in the bottom shelf to keep the fridge cool in case of power failure. (Domestic refrigerators) Try not to open the fridge door more than three times a day.

Key notes to load vaccines in a refrigerator

1) Store Freeze-sensitive vaccine (TT, HepB, DTP -HepB + Hib) in the top basket (Top-opening chest refrigerator). MR, BCG and OPV in the bottom (Top-opening chest refrigerator). Do not keep expired vaccines, NOR vaccines with VVMs that have reached their discard point, NOR reconstituted vaccines for more than six hours. Food and drinks should not be stored in a vaccine refrigerator. Do not put vaccines on the door shelves.

2) 3)

4) 5)

Loading vaccines in Compression Refrigerators

What to do when a vaccine refrigerator is out of order

1) Protecting the vaccines.

Move the vaccines to another place until the refrigerator is repaired.

2) Restoring the refrigerator to work in order.

Check the power or gas supply. If there is no power, make other arrangements until power is restored. Check if the plug correctly in the socket or not. Report to your repair technician or supervisor.  Minor repairs should be carried out in the health centre.  Major repairs, such as replacing a compressor or spark plug/burner jet (Gas), should be carried out by a qualified technician.

Routine maintenance of refrigerator

1) Every day  Check and record the temperature and adjust the thermostat if necessary.  Ensure that the vaccines are kept in order.  (Gas) Check that the colour of the burner flame is blue. If orange, clean the Gas burner.  Keep the refrigerator area clean and free from dust.

Routine maintenance of refrigerator

2) Every week (Gas) Check that there is enough gas in the cylinder Note: Always keep a spare, full gas cylinder available and replace the cylinder before it is completely empty. Check the lid sealing and verify that the lid is locking tightly.

Routine maintenance of refrigerator

2) Every month Check ice on the evaporator. If the ice layer is .5cm thick or more, defrost the unit. Clean the refrigerator inside and out and wipe dry. Clean and dry the rubber seal. Check that the cooling unit is clean. Remove any dirt or dust with a soft brush. (Gas) Check that all gas lines connections are free of leaks.

Practical Cold Chain Equipment Operation How to light a Gas refrigerator

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
11.

If the refrigerator has been on electric operation turn the power off and pull the plug from the socket. Make sure there are no draughts from doors or windows in the room, as these will make it difficult to light the burner. Identify the control knobs and other parts for gas operation. Connect the gas bottle to the refrigerator with the gas supply line and ensure all connections are tight. Turn the gas on and check all connections for leaks (see below). Turn the gas thermostat to the medium position. Open the gas valve knob on the refrigerator (if there is one). Push the button on the flame failure device as far as possible and keep it pushed in for 20 seconds. Push or turn the igniter button to light the gas. You may need to do this a few times before the gas will ignite. Look through the sight glass to see the flame. Once the flame has ignited you need to keep the flame failure device pushed in for about 20 seconds and then release it. Check the flame stays lit; if it goes out repeat the same procedure.

Check for gas leaks

DO NOT smoke or allow any flames near by while checking for gas leaks.
Dissolve some soap in a small quantity of water. Brush all connections and gas supply line with the soapy water. 3. Open the valve on the gas bottle. 4. Watch each connection for bubbles. 5. Bubbles indicate a leak. If there is a leak, turn off the gas supply immediately. 6. Tighten the leaking connection. 7. Check the connection again. 8. If there is still a leak you may need to replace the part. 9. If there is a leak in the gas supply line replace it. 10. If you are unable to repair a leak DO NOT use the refrigerator on gas mode and report it immediately. 11. If the connection no longer leaks check all connections in the same way. 1. 2.

Checking Gas Leaks

Cleaning The Flue and Baffle

1.

2. 3. 4. 5. 6.

7. 8. 9.

Turn off the gas supply. Remove the burner protection plate if there is one. Cover the burner with a piece of cloth to protect it and to collect the dirt. Remove the flue top and remove the baffle from the flue. Clean the baffle with the special brush supplied until dirt stops falling out. Carefully wrap the dirt in the cloth being very careful not to spill any dirt on the burner. Replace the baffle and flue top. Replace the burner protection plate. Light the burner.

Monitoring of Temperature
To monitor the temperature of the main section of a refrigerator you need:
a thermometer; a temperature chart, which you should tape to the outside of the door or have close by the refrigerator.

To monitor the temperature, proceed as follows:

Read temperatures first thing in the morning and before you leave in the afternoon. If the temperature is between +2C to +8C, do not adjust the thermostat. Continue to do this everyday including workdays, weekends, and holidays. Record the temperature for the day and time on the refrigerator temperature chart.

TEMPERATURE

Points To Remember If the temperature is too LOW (below +2C):

Move vaccines to another fridge or store in a cold box or vaccine carrier Turn the thermostat knob so that the arrow points to a lower number. This will make the refrigerator warmer. Check whether the door of the freezer closes properly. The seal may be broken. Check freeze-sensitive vaccines to see whether they have been damaged by freezing by using the shake test

If the temperature is too HIGH (above +8C):

Move vaccines to another fridge or store in a cold box/vaccine carrier.
Make sure that the refrigerator is working: Check if gas or power supply is present. Check whether the door of the refrigerator or the freezing compartment closes properly. The seal may be broken. Check whether frost is preventing cold air in the freezing compartment from entering the refrigerator compartment. Defrost if necessary. Turn the thermostat knob so that the arrow points to a higher number. This will make the refrigerator cooler. If the temperature cannot be maintained between +2C and +8C, store vaccines in another refrigerator until your vaccine refrigerator is repaired.

Vaccines sensitive to freezing

More of a problem if vaccines freeze than if they get slightly warm All vaccines withT: DTP, DT, DTP-HiB, HepaTiTis B and diluenT are sensitive to freezing Therefore vaccines are stored between +2C - +8C

Range
Vaccine HepB Hib (liquid) DTP-HepB+Hib, TT, Hib lyophilised

Cold chain monitoring equipment: Vaccine vial monitors

VVM is a label made of heat-sensitive material, placed on the vial to show cumulative heat exposure over time VVM reduces waste of vaccine, ensuring that only good vaccine is used

Reading Vaccine Vial Monitors

VVM is printed on the vial label or cap
 Show

cumulative, irreversible heat exposure

 As vial is exposed to more heat, the square becomes darker and darker

MULTI-DOSE OPEN VIAL POLICY

Opened vials of Hepatitis B, OPV and TT vaccines May be used in subsequent imm. sessions for a maximum of one month provided the following conditions are met: 1. Expiry date has not passed 2. Vaccines cold chain not broken 3. Vaccine vial septum is not been submerged in water 4. Aseptic technique used to withdraw / administer 5. VVM does not reach discard point Reconstituted vaccine is still within six hours.

THE SHAKE TEST

The shake test can help give an idea whether certain vaccines (OPV, TT or HBV) have been subjected to freezing temperatures which are likely to have damaged them. After freezing, the vaccine no longer has the appearance of a homogenous cloudy liquid, but tends to form flakes which settle at the bottom of the vial after shaking.

THANK YOU