Vaccine Storage and Handling

What is Cold Chain?

• Cold Chain includes all the materials, equipment and procedures needed to maintain vaccines in the required temperature range of +2.0°C to +8.0°C. Cold chain must be maintained from the time of manufacture until the vaccines are administered to individuals.
• Vaccines may lose their potency and effectiveness if they are exposed to adverse storage conditions such as light and/or temperatures outside of +2.0°C to +8.0°C. This can lead to a lack of protection against vaccine preventable diseases.

New Premises Startup

• If your premises is interested in storing publicly funded vaccines, please contact Halton Region Public Health by calling 311.
• Halton Region Public Health will provide you with a list of steps to follow to help you prepare for your inspection.

 Vaccine Thermometers and Data Loggers

Vaccine Refrigerators

Refrigerators used for vaccine storage must be inspected and approved by Halton Region Public Health prior to use.

Staff and Training

• Assign one staff member as the lead, and another staff member as the backup, to monitor vaccine storage and handling practices at your premises.
• All staff must read and be knowledgeable on the content in the Ontario Ministry of Health’s Vaccine Storage and Handling Guidelines (2021) (external PDF). Your premises’ designated lead must train all staff on how to read your facility’s vaccine temperature monitoring device and how to monitor and document vaccine storage temperatures.

Cold Chain Inspections

• The purpose of a cold chain inspection is to:
  • provide education and support for vaccine storage and handling practices; and
  • promote vaccine safety and effectiveness.
• Halton Region Public Health will conduct the following cold chain inspections at premises that store publicly funded vaccines:
  • Annual routine inspections
  • New refrigerator inspections
  • Relocation of existing refrigerator inspections
  • New premises inspections
  • Follow-up inspections, as required
  • Cold chain incident inspections, as required
• Cold Chain Inspectors will attempt to book an inspection during a timeframe that will work best with your premise’s schedule. There may be instances when an unscheduled, drop-in inspection is warranted.
• Please allow 1.5 hours for scheduled inspections.
• The lead staff member or designate responsible for vaccine storage and handling at the premises must be present for the inspection.

Temperature Log Book

• The Temperature Log Book is a record that allows your staff to monitor temperatures and recognize when temperatures go outside of +2.0°C to +8.0°C.
• Ensuring accurate, complete, and up to date documentation of refrigerator temperatures is necessary to protect vaccines.
• Incomplete documentation in your Temperature Log Book may result in a delay in processing your online vaccine orders.
• How to document in your Temperature Log Book:
  • Document the current, maximum, and minimum temperatures twice daily, at the beginning and end of each day, when your premises is open.
  • Ensure that the current, maximum, and minimum temperatures are documented in the correct places as indicated on the log book.
  • Ensure that you reset the maximum and minimum temperatures on the thermometer after each time that the temperature readings are recorded.
    • Variation amongst the ‘Max Temp’ and ‘Min Temp’ recordings on the Temperature Log Book indicates that the maximum and minimum temperatures are being reset.
    • For more information, refer to Troubleshooting Thermometers.
  • Document temperatures to the tenth decimal place (for example, 5.1°C).
  • Include the date, time, initials, and name of your premise.
  • Mark days off as “closed”.
  • Ensure writing is clear and legible.

Vaccine Handling

• When handling vaccines, please ensure that you:
  • only take vaccines out of the refrigerator when ready to administer; and
  • protect vaccines from light.
• Please note that there are specific practices required when using multi-dose format vaccines.
• For COVID-19 Vaccines, please refer to:
  • COVID-19 Vaccine-Relevant Information and Planning Resources, Ministry of Health (external link) for the most up-to-date information and the vaccine-specific product monographs.
  • the Halton-generated vial label to:
    • determine the “use-by date and time”; and
    • document the date and time of first puncture or reconstitution (depending on the vaccine).

Vaccine Ordering

• Refer to the Vaccine Information for Physicians page for the vaccine delivery schedule and information on online vaccine ordering.
  • Note: A minimum of 30 days of temperatures recorded in your Temperature Log Book must be submitted with online vaccine orders. Failure to do so may result in a delay in processing your order due to the required educational follow-up from Halton Region Public Health staff.
• Once you receive your order, immediately place vaccines in the refrigerator.

Inventory Management

When managing your vaccine inventory, please ensure that:

• your office can order vaccines from Halton Region Public Health on a regular basis. Refer to Vaccine Information for Physicians for the current vaccine ordering and delivery schedule and the online vaccine order form.
• you store no more than one month’s supply of vaccine at a time. This reduces vaccine loss in the event that refrigerator temperatures go outside of +2.0°C to +8.0°C. Your office can order vaccines from Halton Region Public Health every 2 weeks.
• you rotate your stock and check expiry dates. Use vaccine with closest expiry, first.

Vaccine Wastage and Returns

• Expired or non-useable vaccines that are in whole, un-punctured vials are to be returned to Halton Region Public Health.
• Partial, multi-dose vials and COVID-19 vaccines (full or partial vials) cannot be returned to Halton Region Public Health.
• Vaccines that cannot be returned to Halton Region Public Health must be disposed of in your premises’ biomedical waste container. Contact Halton Region Public Health by calling 311 if you do not have a process for biomedical waste disposal at your facility.
• COVID-19 vial labels must be destroyed by removing, tearing or marking the label before disposal.
• Any COVID-19 vaccines that are not used before the “use –by date and time” printed on the Halton-generated vial label, must be reported as waste in COVax.

Steps for vaccine returns:

1. Place non-reusable vaccines in a secure bag marked as “WASTE”. Label bag with your premise’s name and Holding Point Code (HAL_OK_#####). Non-reusable vaccines that are being returned do not have to be stored in cold chain.
2. Complete a Non-Reusable Vaccine Return Record (PDF file) and include in bag. Document punctured vials that are disposed of onsite as biomedical waste as wastage on the record.
3. Return vaccines with your bi-weekly delivery courier.

Note: Any vaccine that is returned to Halton Region Public Health is considered wasted and will not be re-used.

Responding to Temperatures Below +2.0°C or Above +8.0°C

Contingency Plans for Refrigerator Malfunction or Power Outage

Packing a Hard-Sided Insulated Container

• Hard-sided insulated containers may be used for short-term storage of vaccines.
• The temperature inside the container must be between +2.0○C and +8.0○C before placing vaccines inside.
• Most insulated containers can maintain the required temperatures for a maximum of 3-4 hours depending several factors.
• If vaccines will be stored for more than 3-4 hours in the insulated container, the icepack(s) and/or gel pack(s) should be removed and replaced.
• A maximum-minimum thermometer must be used to monitor and document the temperature of the insulated container on an hourly basis.
• Specific steps must be followed when preparing and packing a hard-sided insulated container.

Note: In the Ministry of Health’s steps for preparing and packing an insulated container, it states that ‘pre-conditioned ice blankets’ must be used, in addition to the icepacks. Halton Region requires that you use refrigerated water blankets instead of 'pre-conditioned ice blankets."