Cold chain and open vial policy for vaccine
Reading File
Finding Sources
Finding Sources
Searching the Web
WHO cold chain vaccine open vial policy guidelines 2024
Reading File
Finding Sources
Reading File
Reading File
Reading File
I now have comprehensive content from Park's Textbook. Let me compile the full answer.
Cold Chain and Open Vial Policy for Vaccines
(Source: Park's Textbook of Preventive and Social Medicine)
THE COLD CHAIN
The cold chain is a system of storage and transport of vaccines at low temperature from the manufacturer to the actual vaccination site. It is necessary because vaccine failure can occur when vaccines are not stored and transported under strict temperature controls. The success of a national immunization programme depends on the supply chain meeting the 6 Rights:
The right vaccine in the right quantity at the right place at the right time in the right condition (no temperature breaks in the cold chain) and at the right cost.
Temperature Requirements
Vaccines are sensitive biological products. Vaccine potency, once lost, cannot be regained.
Sensitivity to Freezing
The following vaccines must never be frozen and must be protected from sub-zero temperatures:
- Cholera
- DTaP-Hepatitis B-Hib-IPV (hexavalent)
- DTwP or DTwP-Hepatitis B-Hib (pentavalent)
- Hepatitis B (Hep B)
- Hib (liquid)
- Human Papillomavirus (HPV)
- Inactivated Poliovirus (IPV)
- Influenza
- Meningococcal conjugate
- Rabies
- Td/TT
Sensitivity to Heat
Heat sensitivity is classified into 6 groups (A = most sensitive, F = least sensitive). Freeze-dried vaccines rapidly lose potency after reconstitution. Opened multi-dose vials without preservative must be used within 4 hours of opening or kept at +2°C to +8°C during the session, whichever comes first.
Sensitivity to Light
BCG and measles vaccines are also sensitive to light and must be protected from direct sunlight.
Cold Chain Equipment (UIP - India)
Cold chain equipment is classified into:
A. Electrical Equipment
| Equipment | Temperature | Use |
|---|---|---|
| Walk-in Freezer (WIF) | -15°C to -25°C | Bulk OPV storage; preparing frozen ice-packs; national/state level |
| Walk-in Cooler (WIC) | +2°C to +8°C | Large quantities of all UIP vaccines; state/regional/district level |
| Deep Freezer (DF) | -15°C to -25°C | OPV storage at district level; freezing ice-packs at sub-district level |
| Ice-Lined Refrigerator (ILR) | +2°C to +8°C | Storage of all UIP vaccines at PHC/district level |
| Domestic Refrigerator | +2°C to +8°C | Used at PHC/sub-district where ILR unavailable |
WIC and WIF have continuous temperature recorders and alarm systems that activate when temperature exceeds the recommended range.
B. Solar Cold Chain Equipment
- Solar refrigerator battery drive: Uses low-voltage DC compressors; battery charged by solar energy; has two separate compartments (+2°C to +8°C for vaccines, and a freezer at up to -7°C)
- Solar refrigerator direct drive: Uses sun's energy to freeze a phase change material (ice bank) that keeps the unit cold at night and on cloudy days; wired directly to photovoltaic generators
C. Non-Electrical (Transportation) Equipment
- Cold boxes: Insulated containers using frozen ice-packs; used for transporting vaccines from state to district levels
- Vaccine carriers: Smaller insulated carriers with ice-packs; used at the field level (ANM/sub-centre)
- Ice packs: Contain plain water (no salt); should be discarded if leaking
Key note: The risk of cold chain failure is greatest at the sub-centre and village level, which is why vaccines are not stored at sub-centre level and must be supplied on the day of use.
Responsibilities at the Facility
One designated person at each health facility must manage the vaccine cold chain. Duties include:
- Checking and recording vaccine temperatures twice daily (including Sundays/holidays)
- Maintaining stock registers (name of manufacturer, batch number, expiry date)
- Not over-stocking or under-stocking
- Returning unused vaccine vials from session sites on the same day in the cold chain via alternative vaccine delivery
Vaccine Vial Monitor (VVM)
A VVM is a chemical indicator label attached to the vaccine container that travels with the vaccine throughout the entire supply chain. It changes color irreversibly with cumulative heat exposure, helping health workers decide whether a vial is safe to use.
OPEN VIAL POLICY (OVP) 2015
The Open Vial Policy allows reuse of partially used multi-dose vials of applicable vaccines under UIP in subsequent sessions (both fixed and outreach) for up to 4 weeks (28 days), subject to fulfilling certain conditions. This reduces vaccine wastage.
Vaccines Covered Under OVP
✅ Applicable: DPT, TT, Hepatitis B, OPV (oral polio), Liquid Pentavalent, PCV, and injectable IPV
❌ NOT applicable: Measles/MR, BCG, Japanese Encephalitis (JE), Rotavirus
Conditions for Reuse (ALL must be met)
- The expiry date has not passed
- Vaccines have been stored at appropriate temperature (+2°C to +8°C) during both transport and storage at cold chain point
- The vaccine vial septum has NOT been submerged in water or contaminated in any way
- Aseptic technique has been used to withdraw all doses (needle/septum not contaminated)
- The VVM has not reached the discard point
- The vial has not been exposed to direct sunlight
- Date and time of opening must be recorded on all open vials
At the End of Each Session
- All open vials must be returned to the Cold Chain Point
- At the cold chain point, vials are segregated into:
- Re-usable: DPT, TT, Hep B and Pentavalent vials fulfilling the above criteria
- Non-reusable: Open vials of Measles/MR, BCG, and JE
- All open vials of BCG, Measles, and JE must be destroyed within 48 hours or before the next session, whichever is earlier
When to Discard a Vial
A vial should be discarded (and the Medical Officer informed) if:
- VVM has reached/crossed the discard point (or VVM is absent/disfigured)
- No label, partially torn label, or illegible writing
- Any vial thought to have been exposed to a non-sterile withdrawal procedure
- Open vials submerged in water or removed from a vaccine carrier that has water inside
- Vaccine is frozen or contains floccules/foreign body
- There is a crack or leakage in the vial
- Any AEFI (Adverse Event Following Immunization) has been reported - such vials must be retained and stored under proper cold chain until investigation is complete
Cold Chain During Distribution (OVP)
- Maintain ILR temperature between +2°C to +8°C; monitor twice daily including weekends
- Use well-sealed, conditioned ice-packs in vaccine carriers
- Water must not be allowed to accumulate in vaccine carriers (risk of vial septum contamination)
- All vials (open or unopened) must be transported in a zipper bag in the vaccine carrier and recorded in the stock register
Summary Table: OVP at a Glance
| Feature | Detail |
|---|---|
| Duration of reuse | Up to 28 days from opening |
| Applicable vaccines | DPT, TT, Hep B, OPV, Pentavalent, PCV, IPV |
| Excluded vaccines | Measles/MR, BCG, JE, Rotavirus |
| BCG/Measles/JE open vial lifespan | Destroy within 48 hours or before next session |
| Key monitoring device | VVM (Vaccine Vial Monitor) |
| Storage temperature | +2°C to +8°C at all times |
- Park's Textbook of Preventive and Social Medicine, pp. 121-125 (Cold Chain, Temperature Requirements, Equipment)
- Park's Textbook of Preventive and Social Medicine, pp. 124-125 (Open Vial Policy 2015)
This is a shared conversation. Sign in to Orris to start your own chat.