Purpose

This Procedure describes the process of unpacking and storing frozen the COVID-19 ComirnatyTM (Pfizer) dilute to use (concentrate) multidose for 5 to ˂12 years of age formulation vaccine (Comirnaty (Pfizer) 5 to <12 years formulation) in an ultra-low temperature freezer. The nature of this vaccine requires it to be kept at extremely low temperatures during shipment and storage after it arrives. To achieve this, the multiple dose vials of the frozen vaccine are shipped in insulated thermal shipping containers containing dry ice. This allows the vaccine to remain frozen at this low temperature.

Scope

Unpacking of COVID-19 Comirnaty (Pfizer) 5 to <12 years formulation vaccine from shippers containing dry ice (carbon dioxide) and storage in ultra-low temperature freezers, and safe disposal of the dry ice.

Responsibility

  • Only staff suitably trained and competent in handling dry ice (carbon dioxide) may perform this activity. In addition to the PPE provided, staff must wear clothing that covers their legs and arms, and shoes must be completely enclosed.
  • Handling of the frozen vaccine cartons and vials should be performed in pairs. COVID-19 safety measures should also be maintained as far as reasonably practicable.
  • It should be noted that the shipper can weigh as much as 14kg so safe manual handling practices need to be observed.
  • At all stages the vaccine should be handled carefully, avoiding jarring and shaking as much as possible.

Health and safety rules for handling dry ice and working with ultra-low temperature freezers

  • Local safe work practices for using ultra low temperature freezers and dry ice must be observed.
  • Dry ice and ultra-low temperature freezers may cause cold burns, and carbon dioxide gas may cause asphyxiation if it is not allowed to escape into the atmosphere.
  • Always work in pairs when unpacking deliveries from dry ice in a well-ventilated area.
  • PPE for working with the shippers and ultra-low temperature freezer includes goggles or face shields, temperature resistant gloves (or gauntlets) and apron.
  • In addition to the PPE, staff must wear clothing that covers their legs and arms, and shoes must be completely enclosed.
  • Always ensure good ventilation:
    • Ensure that the area is well ventilated and not enclosed
    • Never have personnel accompany shippers containing dry ice if moving via a lift
    • Never place shippers containing dry ice in a cold store or fridge, or other unventilated areas
    • Never drive in a car or other vehicle with dry ice and no ventilation.
  • Always leave the dry ice in the shipper.
  • Do not store dry ice in a sealed airtight container as it will expand and become carbon dioxide gas. This can cause an explosion.
  • First aid for dry ice burns is the same as for heat burns: treat with tepid running water and seek medical attention.
  • Dry ice rapidly sublimates to carbon dioxide gas even at very low temperatures, which may cause difficulty breathing or suffocation. If dry ice has been in a closed area, trailer, or container, open doors and allow adequate ventilation before entering. If you feel short of breath or develop a headache, these may be signs that you have inhaled too much carbon dioxide. Leave the area immediately.
  • Carbon dioxide is heavier than air and accumulates in low, poorly ventilated spaces. Operational practices for accessing a closed area where dry ice is present should be reviewed and agreed upon with your Work, Health and Safety officer.

Specifications for COVID-19 Comirnaty (Pfizer) 5 to <12 years of age formulation candidate packaging

 Thermal shipping container dry ice replenishment instructions - Unpacking the thermal shipping container (page 3)

Vials Cartons Thermal shipper
2mL type 1 glass preservative freeSingle carton holds 10 vials Holds up to 60 cartons per freezer case
A single dose of COMIRNATY™ 5 to <12 years of age formulation once diluted and drawn up is 0.2mL Shippers can hold up to 8 freezer cases
Estimated 9 doses per vial using standard stock needles and syringes 90 doses using standard stock needles and syringesPayload carton submerged in dry ice pellets
10 doses per vial using low dead space needles and syringes (recommended)100 doses using low dead space needles and syringes (recommended)Vials must not be stored in the thermal shipper

Procedure

  • A local safe work practice must be developed to manage this procedure. If there is any distance to travel between the shipper and the ULT freezer use a trolley instead of carrying the shipper box.
  • Familiarise yourself with the shipper, how you will move within the space you are in, who will do which task and safe handling before commencing.
  • Collect ultra-low temperature handling PPE and disposable gloves to wear under the gauntlets.  
  • Work in the designated well-ventilated area, as close as possible to the ULT freezer.
  • Check the lot number, manufacture date and quantities of ordered vaccine vial in thermal shipping container.
  • Check the control panel on the freezer to check that the temperature is within range (check 'temp-alarm' light is not illuminated) and record this on the appropriate documentation.
  • Put on the PPE.
  • Unlock the freezer.
  • Break the seal on the shipper.
  • When you open the thermal shipping container, you will see a temperature-monitoring device embedded in the foam lid. In the thermal shipping container, this lid will be attached to the thermal shipping container. Take caution when opening the lid as you will notice one flap of the thermal shipping container is permanently affixed to the lid. Do not pull this flap. When opening the lid, use the three finger holes in the foam lid, which will then allow the lid to swing open.
  • The temperature-monitoring device continuously tracks the temperature during shipment to ensure the frozen vaccine product has been maintained at the required temperature during transport to vaccination centres. Upon receipt, press and hold the stop button for 5 seconds. Sites are responsible for continuing to monitor the product storage temperature, vials must not be stored in the shipper. NB These devices need to be returned to Pfizer.
  • If any shippers, cartons or vials need to be quarantined following the checks, ensure they are clearly identified in the ULT freezer e.g., in a separate bag. Such quarantine may be for deliveries where the temperature logger shows a temperature excursion.
  • Make sure that you are now wearing waterproof insulated gloves and safety glasses with side shields or safety goggles as you prepare to handle layers of the container that have dry ice. Beneath the foam lid is the dry ice pod, which holds a layer of dry ice to maintain the temperature of the multiple dose vials. There will also be dry ice in compartments in the container that surround the box that holds the vial cartons. Using your waterproof insulated gloves, remove the dry ice pod.
  • You will now see a lid for the box that holds the vial cartons. Open the box and you will see the vial cartons. There will be up to 10 vial cartons inside. Check you have the number of cartons you expected.
  • Remove the box that holds the vial cartons from the thermal shipping container in order to access the vial cartons. 

Caution: If you feel resistance when trying to remove the box that holds the vial cartons, do not pull it out by force. Keep the box inside the thermal shipping container and remove the vial cartons separately using the clear plastic straps.

  • Replace the inner lid on the shipper to contain the dry ice.
  • Open the outer and inner freezer door and immediately transfer the vial cartons into the refrigerator or an ULT freezer, close the inner and outer door and lock it (remove gauntlets if necessary).

Receiving ULT shipper

  • Receipt of ULT thermal shipper at point of vaccination

  • Upon receipt, disable the GPS enabled logger by pressing the stop button on Controlant Monitor for 5 seconds.
  • If the LED indicator light turns green: immediately transfer cartons to ULT freezer or refrigerator.
  • If the LED indicator light turns red or no colour: wait for status report to confirm vaccine viability.
  • If ULT freezer available; transfer trays to URL freezer
  • Remove the dry ice pod from the thermal shipping container.
  • Remove payload box. Some thermal shippers may not contain a payload box and may contain a fixed vial carton compartment instead.
  • Remove vial carton(s) from the payload box or the fixed vial carton compartment, inspect outer cartons for damage and transfer to ULT freezer.
  • Vials may be stored in an ULT freezer until the expiration date. Vials expire on the last day of the 6th month after the manufacture date.
  • Closed vial cartons containing 10 vials may be at room temperature (<25°C) for up to 5 minutes for transfer between ULT environments.
  • After vial cartons are placed in the ULT freezer following room temperature exposure, they must remain in frozen storage for at least 2 hours before they can be removed again for transfer to another ultra-low temperature environment.
  • Close the shipper box and use the trolley to remove it to a pre-identified secure, well-ventilated location.
  • Keep on all PPE, except gauntlets if it is essential to remove them e.g., to open a locked door.
  • Put gauntlets back on again (if removed) and position the shipper box with lid ajar.
  • Ensure the location is secured (e.g., a well-ventilated space with a warning sign) and leave to allow the carbon dioxide to turn to gas (sublime) for at least 24 hours.
  • Check the control panel on the ULT freezer again to ensure 'temp-alarm' light is not illuminated according to freezer Temperature Monitoring and Recording.
  • Remove PPE and store in a designated clean, dry location. If the goggles or visor may be worn by someone else, wash in soapy water or wipe them down with a bactericidal wipe and leave to dry.
  • Remove and discard the disposable gloves according to local waste disposal practices and wash your hands.
  • Once the carbon dioxide has completely sublimed, remove the temperature monitoring device from the shipper and return to Pfizer using the included prelabelled foldable return box.
  • Discard the single-use shippers according to local waste disposal practices and wash your hands. This will include covering the labels regarding the shipper containing dry ice. Use peel-off stickers to cover UN1845 markings.
  • Ensure the Dry Ice UN1845 markings and diamond-shaped Class 9 hazard label on the thermal shipping container are covered by placing blank labels over them, as the container no longer contains dry ice.

COVID-19 Pfizer (COMIRNATY™) 5 to <12 years of age formulation vaccine images

Ultra-low temperature thermal shipper

There are multiple types of thermal shipping containers and vial pack sizes, all with similar components. The example shown below are for illustrative purpose only and may not exactly replicate the type of thermal shipping container you receive.

Vial cartons will be inside either a plastic corrugated box or a bag, which is located inside the vial carton compartment.

Item Description
ADry Ice Pod
BVial Cartons
CVial Carton Compartment or Payload Box
DFoam Lid
EThermal Shipping Container
  • External dimensions: 440 mm x 411 mm x 481 mm
  • Total weight: up to 14 kgs
  • Temparature and location tracking during transportation
  • Each thermal shipper has a reusable GPS enabled temperature monitoring device which will be enabled when the shipper is packed.
  • All shipments will be tracked via the onboard GPC monitoring device to ensure end to end distribution within required temperatures
  • Temperature records of shipment will be provided within 1 hour of pushing the stop button.
Current as at: Wednesday 22 December 2021
Contact page owner: Health Protection NSW