National Vaccine Storage and Handling Guidelines for Immunization Providers (2007)

Section 9 Vaccine Shipments

Contents

9.1 Standard Operating Procedures
9.2 Receiving and Unpacking Vaccine Shipments
9.3 Transporting Vaccine to Off-site Clinics
9.4 Maintaining Temperature During Off-site Clinics
9.5 References

9.1 Standard Operating Procedures

It is important to establish a routine, systematic process for handling vaccine shipments and vaccine transport. Each facility should develop its own written standard operating procedures (SOP), covering every aspect of vaccine shipping: receiving, storing, packing, and transportation. Written SOPs are useful for reference, training, and evaluation and should be included in the Routine Vaccine Storage and Handling Protocols. (See Section 2—Vaccine Storage and Handling Protocols and the Routine Vaccine Storage and Handling Protocols Checklist in the Resources Section for more details.)

9.2 Receiving and Unpacking Vaccine Shipments

Receiving Vaccine Shipments

All staff members who accept vaccine deliveries must be aware of the importance of maintaining the cold chain and of the need to immediately notify the designated vaccine coordinator of the arrival of the vaccine shipment so that it can be handled and stored appropriately.

Checking and Documenting the Condition of a Shipment

When the vaccine shipment is received, it should be examined and refrigerated immediately.

• Open and examine the shipping container and its contents for temperature monitoring device/indicators and for any signs of physical damage.
  
  
• Read and/or stop the recording of the temperature monitoring device upon receipt to determine if they have been activated or alarmed.
  
  
• Determine if the shipping time was less than 48 hours. If the interval between shipment from the supplier and arrival at its destination was more than 48 hours, the chance of a cold chain break is greater.
  
  
• Crosscheck the contents with the packing slip to be sure they match. Remove all contents of the shipping container before returning or storing the shipping container to ensure that all vaccines have been removed and stored appropriately. If there are any discrepancies with the packing slip immediately notify the designated vaccine coordinator.
  
  
• Check the vaccine expiration dates to ensure that you have not received any vaccine or diluent that is already expired or that is short dated.
  
  
• Examine the vaccine and diluent for heat or cold damage.
  
  • Check the cold chain monitor(s) or data loggers to see if the vaccine or diluent has been exposed to temperatures outside the recommended range during transport.
  • Check that inactivated vaccines are cold but not frozen. Refrigerated packs should still be cold. Frozen packs can be melted but the package should still be cold. Vaccines should not be in direct contact with refrigerated or frozen packs. There should be an insulating barrier between the vaccine and the refrigerated or frozen packs, such as crumpled brown packing paper or bubble wrap.
  • Check that diluent is cool or at room temperature. Diluent should not be in direct contact with refrigerated or frozen packs. There should be an insulating barrier between the diluent and the refrigerated or frozen packs.
  • Check that frozen vaccines are frozen.
    
    
• If there are any concerns about the shipment, mark the vaccine and diluent as “DO NOT USE” and store it under appropriate conditions apart from other vaccine supplies until the integrity of the vaccine and diluent is determined.

When the vaccine shipment is received, it should be examined and refrigerated immediately.

9.3 Transporting Vaccine to Off-site Clinics

General Recommendations

The best assurance of vaccine efficacy is to minimize the number of times vaccines are handled and transported. If vaccine transportation to another location is required, it is critical that vaccine potency is protected by maintaining the cold chain at all times.

When transporting vaccines using a personal vehicle, do not place vaccine inside the trunk of the vehicle. The temperature inside the trunk cannot be regulated. Avoid placing the vaccine in direct sunlight, or directly in line with air from the vehicle's heater and air conditioner. Vaccine should not be left unattended in the vehicle. Staff should be instructed to deliver the vaccine directly to the appropriate personnel as soon as possible.

Ensure you are aware of jurisdictional guidelines on transporting open multidose vials. Before transporting open multidose vials to a hospital or health centre, always ensure you know their regulations. Many facilities do not accept open multidose vials due to potential contamination.

The best assurance of vaccine efficacy is to minimize the number of times vaccines are handled and transported. If vaccine transportation to another location is required, it is critical that vaccine potency is protected by maintaining the cold chain at all times.

Transporting Diluent

Those diluents that can be stored at room temperature may be transported either at room temperature or inside the same insulated cooled container as its corresponding vaccine. If transported inside cooled containers with vaccine, diluent must not be in direct contact with refrigerated/frozen packs and must be refrigerated at least 24 hours in advance so as to not raise the temperature of the cooler and the refrigerated vaccines.

If transporting diluent inside an insulated container with vaccine, diluent must not be in direct contact with refrigerated/frozen packs and must be refrigerated at least 24 hours in advance so as to not raise the temperature of the cooler and thus refrigerated vaccines.

Packing Vaccine for Transport to Off-Site Clinics

Packing vaccines for transportation is an art unto itself with many variables to consider, including the ambient temperature, the distance and time in transit, the mode of transportation, and the amount of vaccine being packaged.

Qualification is the process of testing material resulting in a high degree of assurance that a specific process will meet its pre-determined acceptance criteria⁽¹⁾. It is important to test and qualify the method of packing vaccines in order to maintain the cold chain during transportation. The container and packing materials tested should take into account the variables mentioned above.

A consistent approach to packing vaccines must be developed and qualified. Some of the basic principles include:

• An insulated and temperature monitored container must be used when transporting vaccines.
• Pack enough refrigerated or frozen packs to maintain the cold chain.
• Do not use loose or bagged ice.
• The number and placement of refrigerated or frozen packs inside the container will depend on container size, the ambient temperature, and the volume of vaccine.

Vaccines should be transported in insulated containers that have been internally qualified (tested to meet the specific transportation requirements of the region or jurisdiction) to ensure they are capable of maintaining the vaccine at the correct temperatures for the necessary duration. The shipping containers the vaccine arrived in from the manufacturer may be used to transport vaccine if they meet the criteria. Alternatively, use hard-sided plastic insulated containers or newer styrofoam coolers with at least 2-inch thick walls. Banged-up old styrofoam containers and thin-walled styrofoam coolers, such as those purchased to hold beverages, are not acceptable because they cannot consistently maintain appropriate temperatures.

Summer and winter packing configurations will vary by jurisdiction. Consult your local public health office or immunization program* for more information. For example, summer configurations might include insulated material on the bottom of the insulated container, ice packs (preconditioned according to manufacturer's recommendations), gel packs preconditioned to +5°C, insulating barrier, temperature-monitoring device and vaccine, insulating barrier, gel pack preconditioned to +5°C, ice pack (preconditioned according to manufacturer's recommendations), insulating material on top, and frozen ice packs on top with an insulated cover. A winter configuration may include the same materials as the summer configuration, except top packs are not frozen but refrigerated packs, preconditioned to +5°C. In extreme conditions, frozen ice packs may not be used at all.

There are two main types of cooling packs: refrigerator-conditioned (refrigerated at +2°C to +8°C) and frozen packs available for packing vaccines. The use of these packs for transporting vaccines will depend on the ambient temperature, the amount and type of vaccine, and the size of the container.

Packing vaccines for transportation is an art unto itself with many variables to consider, including the ambient temperature, the distance and time in transit, the mode of transportation, the size of the container and the amount of vaccine being packaged. It is very important to qualify a consistent approach to packing vaccines in order to maintain vaccines at the appropriate temperatures during transport.

Ice packs

An ice pack is a flat rectangular plastic container designed to be 7/8 filled with water, frozen, and then used to keep vaccines at the recommended temperatures. Ice packs may have a removable lid for filling or be pre-filled and sealed. Ice packs that are filled with tap water and frozen are the safest type for maintaining the recommended vaccine storage temperature of +2°C to +8°C inside a cold box⁽²⁾.

Commercial coolant packs

There are many different types of gel packs that contain coolants that depress the melting point and ensure the coolant remains cooler than 0°C for longer than water-filled ice packs⁽²⁾.

Caution: There are coolant packs that have freezing points below 0°C and may present a risk of freezing vaccines unless they are properly conditioned before use in the cooler⁽²⁾.

Before purchasing coolant products, request the following information from the manufacturer:

• Validation of their claim about the product's cold life
• Clear instructions on how to freeze and condition the product before use, and how to use them to pack vaccines

Note: Insulating and filler material should not be stored in the same refrigerator as vaccines (whenever possible), since placing room temperature items in the refrigerator may affect the fridge's operating temperature and take up too much space.

Basic principles for packing vaccines

1) Vaccines should be packed in layers using the following materials: refrigerated and/or frozen packs, insulating barrier (e.g. bubble wrap, crumpled brown packing paper, styrofoam peanuts), vaccine, a temperature monitor, and filler materials (may be the same as those used as insulating barriers) to prevent shifting of the contents during transport. The number and placement of refrigerated or frozen packs inside the container will depend on container size, outside temperature, and jurisdictional variations in storage and handling materials.

2) Be sure to place an insulating barrier (e.g., bubble wrap, crumpled brown packing paper, styrofoam peanuts) between the refrigerated or frozen packs and the vaccines to prevent accidental freezing.

3) Pack vaccines in their original packaging on top of the barrier. Do not remove vaccine vials from boxes. Be sure to fill any spaces between vaccine boxes with crumpled paper or other filler to prevent shifting of contents in the insulated container.

4) Use a properly placed min/max thermometer, data logger, or cold chain monitor near the vaccine. The temperature-monitoring device should be placed in the middle of the vaccines and should not come in contact with the refrigerated or frozen packs.

5) Record vaccine type(s), lot numbers, brand names, quantity, date, time, and originating facility on a packing slip on the inside of the container.

6) Attach labels to the outside of the container to clearly identify the contents as being valuable, fragile, and temperature sensitive vaccines that require refrigeration immediately upon shipment arrival.

9.4 Maintaining Temperature During Off-site Clinics

Vaccine must be maintained between +2°C and +8°C during an off-site clinic and should be stored in an insulated container. Pack enough refrigerated or frozen packs to maintain the cold chain. The number and placement of refrigerated or frozen packs inside the container will depend on container size, the ambient temperature, the volume of vaccine and jurisdictional variations. The combination of insulated container and packing material should be qualified to take into account these variables in order to maintain vaccines between +2°C and +8°C, during an off-site clinic.

Keep the container closed as much as possible. A thermometer must be kept in the container with the vaccines, and temperatures checked and recorded periodically to ensure that the cold chain is not broken.

Record temperatures before leaving the facility, periodically during the clinic and upon return to the office, as per jurisdictional recommendations.

9.5 References

1. Bishara RH. Qualification versus validation and good cold chain management practices. Pharmaceutical Manufacturing and Packing Sourcer 2005: 102, 104, 106.

2. Kempe A. Bulk storage and transport of vaccines including outreach clinics. In: Langley A, Grant S, eds. Proceedings of the National Vaccine Storage Workshop. 1^st ed. Brisbane: Queensland Health, 2004: 67-86.