In cases of power failure, the infrastructure for medical spaces is heavily impacted. It makes a compelling case for preplanning for such events. For clinical environments, protecting volatile biologics is high priority. While many do not anticipate an extreme event, the likelihood of a blackout is eminent. The causes may vary, but could be due to extreme weather, natural disasters, power-grid failure, or another local catastrophic event.
Unfortunately, most biologics are volatile in nature. Abrupt changes in temperature can alter their molecular structure and provide an opportunity for harmful bacteria to grow. Statistics indicate that adverse reactions and wasted biologic products (I.e., blood supply, vaccines) stems from contamination due to extended blackouts periods.
Why Protecting Biologics Is Crucial to the General Public
Biologics play a key role in public health and in times of natural disaster, having adequate a blood supply on hand is important. It is a major area of treatment and can extend life for those experiencing a traumatic injury. In other situations, vaccines are highly volatile and must be thrown out if consistent temperature is not maintained.
The FDA has issued specific guidance (CBER) regarding the cold-storage requirements for all biologics including plasma derivatives, platelets, blood, and vaccine products. The aim is to protect the overall purity and potency in the case of any natural disaster I.e., floods, earthquakes.
This can force a global crisis as it takes a great deal of time to mass produce vaccines in high quantities. We have seen evidence of this during the pandemic due to coronavirus. For those involved in a medical environment, they actively have disaster plans in place to protect patients, staff, and the public. In fact, emergency planning is a “practiced” event where personnel reenact an emergency event and test their responsiveness to become more prepared.
The same is true for laboratories and blood banks. Safeguarding valuable biologics is an especially crucial step and can save lives, money, and time. Luckily, due to enhanced technology, there are steps you can take to limit heavy product loss in times of a blackout.
How Can You Mitigate the Potential Loss of Biologics During Prolonged Blackouts?
Cold-storage considerations for blackouts during extended periods of power failure involves preplanning. Investing in quality products and tools can help ease the minds of stakeholders and personnel. Cold storage solutions have come along way and can provide some help in the way of protecting valuable biologics. Power failure best practices include:
- Investing in temperature alarm-equipped refrigeration and freezers.
- During the event of a blackout, keep all refrigerator and freezer doors closed to conserve the cold mass index. Make sure you apply signage to the door indicating it must be kept closed. Insulating material such as bubble wrap is also good to have on hand.
- Storing ice packs in the freezer and large jugs of water in the refrigerator along with thevaccines helps to achieve a stable, cold temperature.
- Plan for alternative cold-storage location where biologics can quickly be rehoused if possible.
- Do not place vaccines in bar refrigeration units or home units as they are not temperature-controlled environments and put products at risk before a power failure.
- A back-up power supply is advised.
- A temperature data logging device with text or email alerts is also suggested.
When Power is Restored to Your Site Do the Following:
- Record the minimum and maximum temperatures for any affected refrigeration and/or freezer units.
- Reset the refrigerator temperature when the temperature reaches +8°C or less.
- If the temperature readings are outside 2 °C to 8 °C, complete a cold chain breach report if applicable.
- Do not use or discard vaccine without approval and documentation from guidance professionals.
- Monitor the refrigerator closely (e.g., hourly) to ensure that the temperature is consistently stable, then return to normal SOP practices.
- Keep in mind equipment without surge protection may be compromised during an outage event or upon restart as the initial draw of power to all equipment in your building can create temporary unstable power conditions.
General Information for the Cold Storage of Biologics That Are Contained at In-Home Environments or Smaller Clinics
There are some extended care homes and smaller clinics with limited quantities of various biologics that could be affected during blackouts. Studies have shown that most refrigerated vaccines are stable at room temperature for limited periods of time - this is vaccine-type dependent.
Products stored in a closed refrigerator (or freezer, if appropriate) during a power outage may maintain their potency unless the power outage is of such duration that the internal temperature is affected. It is recommended that thermometers be in the refrigerator and freezer section so that temperatures can be read when power resumes to see if excursions outside of recommended temperatures have occurred.
There is some evidence that lyophilized coagulation products such as Factor VIII and Factor IX may be stored at room temperature for extended periods without the loss of potency. If you are concerned about the exposure or efficacy of a particular product, please call the supplier or the manufacturers' customer service department
Many immune globulin products are licensed for storage at 36 to 46° Fahrenheit, and some products may be stored at room temperature for all or part of the time before expiration.
However, storage recommendations do vary for Immune Globulin Intravenous (IGIV), intramuscular IG (IG), and subcutaneous IG (IGSC) products, therefore, all patients and caregivers should refer to the packaged guidance labels with regards to storage temperature guidance. Products requiring lower temperatures can be stored on wet ice.
*These products should not be frozen and the package inserts might provide some specific temperature guidance.
Partnering with K2 Scientific for Cold Storage Products and Recommendations
Power failures will occur and preparedness is key. Our team is well-versed in cold-storage requirements for biologics and vaccines. K2 Scientific also and offers FDA compliant refrigeration and freezer units for blood bank storage. For added security, we offer advanced tools and technology to help monitor your product loads. Learn more about our competitively priced cold storage solutions here.