Melissa Abd RaffurPegawai Farmasi U41

Hospital Hulu Terengganu

An Integrated, Planned And Coordinated System Of Ordering,

Transporting And Storing Vaccines With Specific Safe Temperature Ranges To Ensure Potency And

Efficacy

Vaccine / Cold Medicine Potency

1.Excessive heat or cold exposure damages vaccine/ cold medicine, resulting in loss of potency. Once potency is lost, it can never be restored.

2.Each time vaccine/cold medicine is exposed to heat or cold, the loss of potency increases and eventually, if the cold chain is not correctly maintained, all potency will be lost, and the vaccine becomes useless.

Appearance of Medicine After Exposure to Inappropriate Storage Conditions

1.Some medicine may show physical evidence of altered potency (eg. clumping in the solution that does not go away when the vial is shaken)

2.Other medicine may look perfectly normal. Eg. inactivated vaccines exposed to

freezing temperatures (i.e. 0°C or colder) may not appear frozen and give no indication of loss of potency.

Loss of vaccine potency due to improper storage conditions is a costly mistake.

Patients receiving vaccine with decreased potency caused by improper storage conditions may not be fully protected against the vaccine-preventable disease.

Recalling patients to repeat vaccine doses because vaccine has been stored improperly can damage public confidence in vaccines and in your practice.

Vaccines are also expensive. Avoid extra expenses by following procedures to maintain the cold chain

• An insulated container that can be lined with ice-packs to keep vaccines and diluents cold during transportation and /or for short period storage ( 2-7 days)

• Selected according to their cold life

• Made of polyurethane material – durable and robust

• Insulated container like cold box but smaller in size that can be lined with ice-packs to keep vaccines and diluents cold during transportation or temporary storage, to outreach sites or immunization sessions.

• Stay cold at a maximum of 48 hour with lid closed.

• Used to store vaccines when refrigerator is out of order or defrosted.

• A soft foam that fits on top of the ice-packs in the vaccine carrier.

• Incision are made on it to allow vaccines to be inserted in the foam

• Serve as a temporary lid to keep unopened vaccines inside the carrier cool while providing a surface to hold, protect and keep cool opened vaccine vials.

• Flat, square plastic bottles that are filled with water and frozen.

• Used to keep vaccines cool inside the vaccine carrier / cold box

• The number of ice-pack required for a cold box or vaccine carrier varies.

• It takes 24 hours to freeze 1 ice-pack

0.3L

0.6L

To keep track of the temperature to which vaccines and diluents are exposed during transportation and storage.

a.Vaccine Vial Monitors

b.Vaccine Cold Chain Monitoring Card

c.Thermometer and Thermostat

d.Freeze Watch

A label that changes color when the vaccine has been exposed to heat over a period of time .

1. Indicator strip changes color from white to blue when vaccines are exposed to temperature that are too high, +10C to more +34C for at least 2 hours.

2. VCCM is used to estimate the length of time that the vaccine has been exposed to high temperature.

• Records the day’s high and low temperature

• Right side- register the maximum temperature since the last setting while the left side shows the minimum temperature

• Temperature ranges from 0 - ± 300C / 500C.

The needle moves around the scale, pointing to plus (+) numbers when it is warmer and to minus (-) numbers when it is colder

• Indicator changes color from white to red when vaccines are exposed at temperature below 0 C for 1 hour.

• Used to warn of freezing and is packed with vaccines that are sensitive to freezing temperature : DTP, TT, DT, Td (titik beku -6.5°C), Hepatitis B (-0.5°C), Liq.Hib

• Cold Chain equipment, including refrigerators, cold boxes and vaccine carrier must be loaded correctly to maintain the temperature of the vaccines and diluents inside.

• There should be one person who has the main responsibility for the refrigerator :

1. Storing vaccines, diluent and ice-pack2. Checking and recording the temperature

twice daily, even on week-ends3. Maintain the cold chain equipment

1. Do not put vaccines on the door shelves. The temperature is too warm to store vaccines. When the door is opened, shelves are instantly exposed to room temperature

2. Do not keep expired vaccines or reconstituted vaccines more than six hours

3. Food and drinks should not be stored in a vaccine refrigerator

4. Do not open the refrigerator door frequently since this will raises the temperature inside the refrigerator

1. Fill with water leaving a little air space at the top and put the cap on tightly.

2. Hold each ice-pack upside down and squeeze it to make sure it does not leak

3. Put each ice-pack upright or on their sides in the freezer so that the surface of each ice-pack is touching the evaporator plate, close the door

4. Leave ice-pack in the freezer at least 24 hours to freeze solid

5. Keep extra unfrozen ice-packs on the bottom part of the refrigerator to keep cold in case of a power failure

6. Do not store frozen ice packs in the refrigerator compartment as this will increase risk of freezing.

7. Allow ice-pack to start melting before putting them in the cold box containing freeze-sensitive vaccine to prevent from freezing.

Thermometer , Thermostat and Temperature Chart

1.Set the refrigerator thermostat during the coldest part of the day to around +2° C to +4 ° C

2.Monitor temperature first thing in the morning and before you leave. If the temperature is bet. +2° C to +8° C, do not adjust the thermostat

3.Continue to monitor the temperature twice a day on weekdays, weekends and holidays

4. If the temperature is too LOW ( below +2° C)a) Turn the thermostat knob to a lower number

to make the refrigerator warmer.

b) Check whether the door of the freezer closes properly. The seal may be broken.

c) Check freeze-sensitive vaccines ( DPT, DT, Td, TT, Hep B, ) to see whether they have been damaged by freezing by using the shake test.

Freezing damaged adsorbed vaccines (DTP, DT, Td, TT or Hepatitis B)

5. If the temperature is too HIGH ( above +8° C)a. Make sure that the refrigerator is working,

check the power supply.

b. Check whether the door of the refrigerator or freezer closes properly. The seal may be broken.

c. Check whether frost is preventing cold air in the freezing compartment from entering the refrigerator compartment. Defrost if necessary.

d. Turn the thermostat knob to a higher number to make the refrigerator cooler.

e. If the temperature cannot be maintained between 2° C to 8° C, store vaccine in another place until refrigerator is repaired

f. Do not adjust thermometer to a higher (cooler) setting after a power cut or when vaccines arrives. This could freeze the vaccines.

Vaccine Refrigerators

a. Defrost when the ice becomes > 0.5 cm thick, or once a month, which ever comes first

b. Thick ice does not keep the refrigerator cool. Instead it makes the refrigerator work harder and use more power

Vaccine Refrigeratorsc. To defrost and clean refrigerator: Take out all the most heat-sensitive

vaccines and diluents, and transfer to a cold box lined with frozen ice-packs.

Take out all the freeze-sensitive vaccines and diluents, and transfer to a cold box lined with conditioned ice-packs.

After cleaning, wait till the temperature in the main section falls to +8° C or lower before return the vaccines, diluents and ice-packs to their appropriate place.

When vaccine refrigerator is out of order…

If < 4 hours, do not open the refrigerator, the temperature will rise 1° C / hour

If > 4 hour, transfer to another refrigerator or cold box or vaccine carrier lined with conditioned ice-packs for temporary storage.

Always keep a freezer indicator with the freeze-sensitive vaccines to monitor eventual freezing.

Cold Box & Vaccine Carrier.

• Must be well dried after use. If they are left wet with lids closed, they will becomes moldy. Mould may affect the seal of the cold boxes and vaccines carriers. Stored with lid open when not in used.

• Protect from knocks and sunlight which can cause cracks in the wall and lids which may exposed the vaccines to heat

  Primary Intermediate Health   Centre

Health            PostRegion District

6 monthsa 3 months 1 month 1 month Daily use

OPV -15oC to -25oC

+2oC to +8oC

BCG WHO no longer recommends that freeze-dried vaccines be stored at

–20°C. Storing them at –20°C is not harmful but it is unnecessary. Instead, these vaccines should be

kept in refrigeration and transported at +2°C to +8°C.

Measles

MMRMRYellow Fever

Hib freeze-dried

Hep B    DTP-Hep B

Hib liquid

DTPDTTTTdNote a. 6 months is the maximum recommended storage time at primary level. This includes the period required to obtain clearance from the National Regulatory Authority.

1. Some vaccines are very sensitive to strong light and their exposure to ultraviolet light causes loss of potency. The must be protected against sunlight or fluorescent ( neon) like.

2. BCG, measles, MR, MMR and rubella vaccines are equally sensitive to light ( as well as to heat)

3. Normally , these vaccines are supplied in vials made from dark brown glass to protect them against light damage, but care must still be taken to keep them covered and protected from strong light at all times

1. ORDERING - DO NOT OVERSTOCK Max – 6wks stock , min 3 wks

stock - Quantity estimation consider : - Qty. used since last order - Safe max. volume for your fridge. - Left over stock - Seasonal variation - Disease outbreak & special

programs

- Use vaccines with shortest exp. date first

2. RECEIVING Check packing/ice pack still cool upon receiving Check the contents match the order Check the monitor cards & record status Immediately store vacc. in fridge

3. STORING - leave vacc. in their packaging as this provide insulation & protect against thermal insult. - keep monitor cards together with the vacc. - Fill the door & drawer with bottles of water. - Vaccine stock not exceed 50% of domestic fridge vol.,

P’ceutical fridge – 90%. - Allow for air circulation in fridge.

4. VACCINES MUST NOT Be stacked against the refrigerator walls Placed by the rear freeze plate or icebox of refrigerator Placed in refrigerator door

5. EQUIPMENT (FRIDGE) In a well ventilated room Away from direct sunlight Away from any heat source (autoclave, heater)