How to Perform a Self Audit Before a Vaccine Storage Regulatory Audit

Posted by Mike Blazes on 22 November, 2017

Vaccine storage is vital to maintaining the accuracy and efficacy of the vaccines administered today. Whether it be in a doctor’s office, medical research facility, hospital or outpatient clinic, vaccine storage requires reliable monitoring  to verify the correct temperature and environmental conditions. Vaccines can be ruined due to careless handling, and without proper monitoring could be administered ineffective. Regulatory organizations perform standard audits to examine procedures for vaccine storage. To ensure your storage methods meet required guidelines, follow these five steps.

1. Timing. Before you even begin the storage methods of vaccines, establish a schedule for ordering, whatever type of vaccines it might be. For instance, vaccinations for the flu season can begin as early asiStock-612624124.jpg August. If you are a healthcare provider, determine when you will begin to administer the vaccine and build out a calendar from that. Vaccines have a shelf life, and their efficacy diminishes beyond it; ordering a supply of vaccines to sit on the shelf for an extended period won’t bode well.

2. Establish Protocol. From ordering the vaccines to accepting delivery to handling the vaccines for distribution, you must have a comprehensive plan for each step to maintain the integrity of the vaccines. Designating specific personnel to handle a this process can eliminate vaccine mishandling. Have this plan visible within the area that the vaccines are stored so that there is a visual degree of accountability apparent to anyone entering the environment where the vaccines are stored.vaccine_fridge.png

3. Refrigeration. Where you store the vaccines is probably the most critical aspect of this process.  You need to make sure there is a reliable refrigerator monitoring system to track temperature fluctuations within the refrigerator or cooling facility, minimum and maximum temperatures; maintain the internal and external environment of the storage facility and the environment it sits in, say a closet or storage room; and send 24 hour monitoring alerts if there are issues that arise like a power outage or surge, a door left open or an issue with internal temperature control.

4. Storing Your Vaccines. You’ve ordered your vaccines, and they are delivered. Before you begin to store them, be aware of the amount of space you have allotted for this. You can not have a crowded storage area; that can result in a temperature variance. Vaccines need space. It is best to place the vaccines in the center of the refrigerator, away from walls or vents; do not place them on the doors or in bins. You want to be sure the vaccines reside in the area that will have the most accurate temperature. Keep the vaccines in their original packing with the date facing forward. Be sure to have a monitoring log for tracking every vaccine order that comes in and out of your facility.

5. Distribution. Transporting vaccines can be a delicate endeavor as you are removing the vaccines from a stable environment to what is hopefully another stable and portable environment. Distribution requires each of the previous steps’ guidelines only in a portable manner. Things to consider in distribution are the type of container used to store the vaccines; the monitoring mechanism used to ensure the temperature within; the amount of space needed to store the vaccines; the handling of the vaccines from one storage container to the next; the timing of the delivery from point A to point B.


Like all of the previous steps, one of the most critical aspects of vaccines storage remains accountability. A comprehensive step-by-step process with specially trained designated personnel as well as an accurate and continuous temperature monitoring system is necessary to ensure the integrity of the vaccines.A cloud-based systemwith a digital data logger will ensure the process and provide ongoing documentation necessary to maintain guidelines for vaccine storage.


Ensure Compliance for VFC

Topics: Ever Wondered....?

Written by Mike Blazes

Michael Blazes is the Chief Executive and champion for Control Company, the laboratory test, measurement, and monitoring instrument company that has been bringing innovative Traceable® branded products to prominent biopharmaceutical and healthcare organizations and institutions around the world for the past 40 years. Mike has 20 years’ experience in the laboratory products and equipment industry. He brings a commitment to developing and manufacturing the most reliable biopharmaceutical packaging, research and manufacturing tools, and test, measurement and monitoring instruments. By working with key opinion leaders and innovators, Mike and his teams’ focus has always been on leveraging technology and optimized processes to make healthcare more effective, efficient and productive. Mike’s experience was founded in education at the United States Air Force Academy, and advanced with a graduate degree from Colorado State University.
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