Cold Chain Protocol - Vaccines and Biologics



8.  Managing Cold Chain Problems

Relevant Reference Materials:

Cold Chain Failures Happen…Regardless of How…Take Action!

8.1.  What to do when the temperature in the refrigerator goes out of the recommended temperature range for the product

For refrigerated vaccines, a temperature reading of below +2°C or above +8°C means that the vaccines and biologics have been exposed to temperatures outside of the manufacturer’s storage recommendation and may have lost potency. This is referred to as an Adverse Storage Condition (ASC).

If a cold chain failure occurs, the Vaccine Coordinator or back-up should be informed as soon as possible.

Required Actions by the Vaccine Coordinator or designated back-up in the case of an Adverse Storage Condition in a regrigerator (recommended storage between 2-8°C
Action 1
  • Conduct a quick assessment of the situation to determine if the issue can immediately be identified (i.e. power disconnected, fridge door ajar or opened too frequently, temperature probe misplacement, etc.)
  • Put affected product into a separate container (ex. paper bag) marked “DO NOT USE.”
  • Place product in a functioning and monitored refrigerator or cooler until clear instructions have been received about next steps.
  • The vaccines and biologics may still be viable. Don’t assume the vaccines cannot be salvaged.
Action 2
  • Begin completing the Adverse Storage Condition Form according to the Manitoba Health Adverse Storage Condition (ASC) Form and Procedure document. For Public Health Information Management System (PHIMS) users, create a new ASC directly in PHIMS (unless otherwise directed to use the online form).
  • Begin to rectify any large issues as needed to bring the refrigerator into working order.
Action 3
  • Calculate the maximum length of time the stock was possibly exposed to temperatures outside the manufacturer recommended 2°C to 8°C range. If the specific time and temperature details are not available, use the time of the last temperature check as when the refrigerator malfunctioned.
Action 4
  • Review the most current product monographs for stability information outside of 2-8°C.
  • If required, contact the manufacturers and provide details on the exposure and request direction regarding viability of the product. Indicate the results on the Cold Chain Failure Response Form.
Action 5
  • If deemed useable, clearly identify on the product (e.g., with a sticker) the date of the cold chain failure and the number of hours exposed. Use at the first opportunity.
Action 6
  • Fax completed Adverse Storage Condition Form to Communicable Disease Control, Manitoba Health at 204-948-2040. If completing an ASC directly in PHIMS, send an email to vaccines@gov.mb.ca to notify Health that an ASC has been completed and include the ASC ID# in your communication.
Action 7
  • Vaccines deemed NOT useable can be removed from the refrigerator and returned to the Provincial Vaccine Warehouse for potential cost recovery and/or destruction.
  • Consult Manitoba Health prior to ordering replacement product or returning product to the Provincial Vaccine Warehouse.
  • After approval for return is given by Manitoba Health contact the Provincial Vaccine Warehouse for return instructions at 204-948-1333 or Toll Free: 855-683-3306.

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8.2.  What to do when the temperature in the freezer goes out of the recommended temperature range for the product

A temperature reading of the following:

  • Below -80°C or above -60°C (for the Pfizer COVID-19 Vaccine)
  • Below -25°C or above -15°C (for the Moderna COVID-19 Vaccine)

means that the vaccines and biologics have been exposed to temperatures outside of the manufacturer's recommended storage conditions and may have lost potency, this is referred to as an "Adverse Storage Condition (ASC)".

If an ASC occurs, the Vaccine Coordinator or designated back up should be informed as soon as possible.

Required Actions by the Vaccine Coordinator or designated back-up in the case of an Adverse Storage Condition in a -80°C freezer:
Action 1
  • Conduct a quick assessment of the situation to determine if the issue can immediately be identified (i.e. power disconnected, freezer door ajar or opened too frequently, temperature probe misplacement, etc.)
  • Mark the affected Pfizer product with a removable label indicating: "DO NOT USE."
  • Ensure that the product is kept stored in a functioning and monitored -80°C freezer.
  • If the issue identified is that the freezer itself is malfunctioning, the following options (in recommended order) may be used:
    1. Move the product to a functioning and monitored back up -80°C freezer.
    2. If no back up freezer is available on site, move the affected product to the manufacturer supplied thermal shipper and follow the manufacturer's Thermal Shipping Container: Dry Ice Replenishment Instructions. Ensure that you include an appropriate temperature-monitoring device within the shipper and follow the Safe Handling Guideline for Dry Ice, which is also available for download on the webpage above.
    3. If dry ice is required, refer to Appendix 8: Contact Information and Procedure for Accessing Emergency Dry Ice within Winnipeg
  • If there is no back up freezer available on site or nearby, and the maintenance or replacement of the malfunctioning freezer will not be complete immediately, locations in Winnipeg and surrounding areas may call the Provincial Distribution Warehouse (MDA) to arrange for the vaccine to be returned to the warehouse for temporary storage while the on site freezer is serviced or replaced. An effort should be made using one of the options above to keep the product frozen until it is returned to the warehouse.
  • The product may be placed in a functioning and monitored refrigerator at a last resort. The Pfizer vaccine cannot be re-frozen once it is in a thawed state. If this option is used, timing of when the thawing process began must be documented and the product must be used within the amount of time specified by the manufacturer in the product monograph.
  • The vaccines may still be viable. Do not assume the vaccines cannot be salvaged.
Action 2
  • Begin completing the Adverse Storage Condition Form according to the Manitoba Health Adverse Storage Condition (ASC) Form and Procedure document. For Public Health Information Management System (PHIMS) users, create a new ASC directly in PHIMS (unless otherwise directed to use the online form).
  • Begin to rectify any large issues as needed to bring the freezer into working order.
Action 3
  • Calculate the maximum length of time of the exposure to temperatures outside the manufacturer recommended range. If the specific time and temperature details are not available, use the time of the last temperature check as when the freezer malfunctioned.
Action 4
  • Review the most current product monographs for stability information outside of the recommended storage temperature range.
  • Contact the manufacturer and provide the details on the temperature excursion:
  • Once the viability of the vaccine has been determined by the manufacturer, indicate the results on the Adverse Storage Condition Form (or directly in PHIMS, if applicable). Whenever possible, request a written copy of the decision from the manufacturer.
Action 5
  • If deemed useable, clearly identify on the product (e.g., with a sticker) the date of the temperature excursion and the number of hours/minutes exposed. Use at the first opportunity.
Action 6
  • Fax completed Adverse Storage Condition Form to Communicable Disease Control, Manitoba Health at 204-948-2040 along with any written information received from the manufacturer. If completing an ASC directly in PHIMS, send an email to vaccines@gov.mb.ca to notify Health that an ASC has been completed and include the ASC ID# in your communication.
Action 7
  • Vaccines deemed NOT useable can be removed from the freezer and returned to the Provincial Vaccine Warehouse for potential cost recovery and/or destruction.
  • Consult Manitoba Health prior to ordering replacement product or returning product to the Provincial Vaccine Warehouse.
  • After approval for return is given by Manitoba Health, contact the Provincial Vaccine Warehouse for return instructions at 204-948-1333 or Toll Free: 855-683-3306.
Required Actions by the Vaccine Coordinator or designated back-up in the case of an Adverse Storage Condition in a -20°C freezer:
Action 1
  • Conduct a quick assessment of the situation to determine if the issue can immediately be identified (i.e. power disconnected, freezer door ajar or opened too frequently, temperature probe misplacement, etc.)
  • Mark the affected Moderna product with a removable label indicating: "DO NOT USE."
  • Ensure that the product is kept stored in a functioning and monitored -20°C freezer.
  • If the issue identified is that the freezer itself is malfunctioning, the following options (in recommended order) may be used:
    1. Move the product to a functioning and monitored back up -20°C freezer.
    2. If no -20°C freezer is available on site, move the product to any available functioning and monitored freezer.
    3. If no back up freezer is available on site, move product to a vaccine cooler and pack with ice packs. Ensure that a temperature monitor is included with the vaccine and that the ice packs do not have direct contact with the vials.
  • If there is no back up freezer available on site and the maintenance or replacement of the malfunctioning freezer will not be complete immediately, locations in Winnipeg and surrounding areas may call the Provincial Distribution Warehouse (MDA) to arrange for the vaccine to be returned to the warehouse for temporary storage while the on site freezer is serviced or replaced . An effort must be made using one of either option 2 or 3 above to keep the product frozen until it is returned to the warehouse.
  • The product may be placed in a functioning and monitored refrigerator at a last resort. The Moderna vaccine cannot be re-frozen once it is in a thawed state. If this option is used, timing of when the thawing process began must be documented and the product must be used within the amount of time specified by the manufacturer in the product monograph.
  • The vaccines may still be viable. Do not assume the vaccines cannot be salvaged.
Action 2
  • Begin completing the Adverse Storage Condition Form according to the Manitoba Health Adverse Storage Condition (ASC) Form and Procedure document. For Public Health Information Management System (PHIMS) users, create a new ASC directly in PHIMS (unless otherwise directed to use the online form).
  • Begin to rectify any large issues as needed to bring the freezer into working order.
Action 3
  • Calculate the maximum length of time of the exposure to temperatures outside the manufacturer recommended range. If the specific time and temperature details are not available, use the time of the last temperature check as when the freezer malfunctioned.
Action 4
  • Review the most current product monographs for stability information outside of the recommended storage temperature range.
  • Contact the manufacturer and provide the details on the temperature excursion:
  • Once the viability of the vaccine has been determined by the manufacturer, indicate the results on the Adverse Storage Condition Form (or directly in PHIMS, if applicable). Whenever possible, request a written copy of the decision from the manufacturer.
Action 5
  • If deemed useable, clearly identify on the product (e.g., with a sticker) the date of the temperature excursion and the number of hours/minutes exposed. Use at the first opportunity.
Action 6
  • Fax completed Adverse Storage Condition Form to Communicable Disease Control, Manitoba Health at 204-948-2040. If completing an ASC directly in PHIMS, send an email to vaccines@gov.mb.ca to notify Health that an ASC has been completed and include the ASC ID# in your communication.
Action 7
  • Vaccines deemed NOT useable can be removed from the freezer and returned to the Provincial Vaccine Warehouse for potential cost recovery and/or destruction.
  • Consult Manitoba Health prior to ordering replacement product or returning product to the Provincial Vaccine Warehouse.
  • After approval for return is given by Manitoba Health, contact the Provincial Vaccine Warehouse for return instructions at 204-948-1333 or Toll Free: 855-683-3306.
 

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8.3.  Inventory Management of Cold Chain Failures

In most circumstances, replacement of stock can occur once the cause of the cold chain failure has been rectified and the Cold Chain Failure Response Form has been completed and faxed to Communicable Disease Control, Manitoba Health.

Actions for product exposed to a cold chain failure but deemed useable:

  1. Clearly mark on the product (e.g., with a sticker) the date of the cold chain failure and the number of hours exposed. Two or more exposures may require special consideration by the manufacturer if the product can still be used.
  2. Use up product exposed to a cold chain failure before using other stock.

Actions when product deemed unusable is inadvertently used:

  1. Contact the applicable product manufacturer(s) about appropriate actions/next steps and provide them with the following information to help with assessing the situation:
    •     name of the product,
    •     duration and temperature of exposure,
    •     whether multi-dose vials were open at the time of exposure,
    •     the number of doses, and
    •     the date the dose(s) were administered.
    •     any other information requested by the manufacturer.
  2. People immunized with a vaccine or biologic with questionable potency may need to be tested for serologic evidence of immunity (presence of protective antibody levels) or be re-immunized. The local Medical Officer of Health within the Regional Health or First Nations Authority can be consulted on these matters.
Note: On occasion, vaccines or biologics may be required for an immediate situation. If the current supply has potentially been compromised by a cold chain failure, special arrangements can be made by contacting the Provincial Vaccine Warehouse at 204-948-1333 or Toll-Free 855-683-3306 during regular working hours to obtain a temporary/one week supply of replacement stock.

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8.4.  Refrigerator Malfunctions

When the refrigerator containing vaccines and biologics is not working it is important to determine if the malfunction can be corrected quickly. Please refer to Appendix 3: Malfunctioning Refrigerator Trouble Shooting Checklist and Appendix 4: Algorithm to Assess Problems in Temperature Readings for required actions during a refrigerator malfunction.

Note: If the malfunction cannot be corrected quickly (< 3 hours) alternative storage for the stock is required as products cannot remain in a non-functioning refrigerator for an extended period of time.

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8.5.  Freezer Malfunctions

When the freezer containing vaccines and biologics is not working it is important to determine if the malfunction can be corrected quickly. Please refer to Appendix 7: Malfunctioning Freezer Trouble Shooting Checklist and Appendix 4: Algorithm to Assess Problems in Temperature Readings for required actions during a refrigerator malfunction.

Note: If the malfunction cannot be corrected quickly (< 3 hours) alternative storage for the stock is required as products cannot remain in a non-functioning freezer for an extended period of time.

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