General Guidelines for Maintaining and Managing Vaccine Storage and Handling
The concern for potential errors in vaccine cold chain management led to the release, by the Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP) in early 2002, of the revised General Recommendations of Immunization which included recommendations for immunobiologics storage and handling. This notice advises vaccine providers of the importance of proper cold chain management practices, describes storage unit and temperature requirements and recommends a universal vaccine temperature-monitoring program.
It is known scientifically that exposure of vaccines to temperatures outside the recommended ranges would affect potency adversely and reduce the protection, in recipients, from vaccine-preventable diseases. Good vaccine storage and handling practices can ensure the realization of the full benefit of immunization.
Recommended Vaccine Storage Temperatures
The majority of vaccines requires storage temperatures of 35°F - 46°F (2°C - 8°C) and must not be exposed to freezing temperatures. However, Varicella Vaccine and Live Attenuated Influenza Vaccine (LAIV) increased the complexity of vaccine storage. Both vaccines must be stored in a continuously frozen state <5°F (15°C) with no freeze-thaw cycles.
Freezing temperatures can irreversibly reduce the potency of vaccines normally stored at 35°F - 46°F (2°C - 8°C). Certain freeze-sensitive vaccines contain an aluminum adjuvant that precipitates when exposed to freezing temperatures. This results in loss of the adjuvant effect and vaccine potency. Physical changes in the vaccine are not always apparent after exposure to freezing temperatures and visible signs of freezing are not necessary indicators of decrease in vaccine potency.
Although the potency of the majority of vaccines can be affected negatively by storage temperatures that are too warm, these effects are usually more gradual and manageable than losses resulting from extremely cold temperatures.. In contrast, Varicella Vaccine and LAIV are required to be stored in continuously in frozen states and their potency will decrease when stored above the recommended temperature range.
Vaccine Storage Requirements
The selection and use of vaccine storage units must meet specific requirements. A consumer-oriented combination refrigerator/freezer unit is acceptable for vaccine storage if the refrigerator and freezer compartments each have a separate door. However, vaccines are not to be stored near the cold air outlet from the freezer to the refrigerator. Many combination units with independent compartment thermostat controls but using air from the freezer compartment to cool the refrigerator compartment are not ideal for vaccine storage as there may be different temperature zones within the refrigerator.
Refrigerators without freezers and stand-alone freezers usually perform better at maintaining the precise temperatures required for vaccine storage. Any refrigerator or freezer used for vaccine storage must maintain the required temperature range year-round, be large enough to hold the year's largest inventory and be dedicated to storage of biologics. In addition, vaccines should be stored centrally in the refrigerator or freezer, away from the walls and not by the door or on the storage unit bottom.
Temperature Monitoring
Proper temperature monitoring is critical to proper cold chain management. Precision thermometers should be placed in a central location in the storage unit and adjacent to the vaccine. Temperatures should be read and documented twice each day, once when the office or clinic opens and once at the end of the day. Temperature logs should be kept on file (for greater or equal to 3 years, unless state statutes or rules require a longer period). Immediate action is to be taken to correct storage temperatures that are outside the recommended ranges and vaccine mishandling should be avoided at all times.
An assigned, dedicated person should be responsible for maintaining temperature logs, along with one backup person. Temperature logs should be reviewed by the backup person at least weekly. Everyone working with vaccines should be familiar with proper temperature monitoring.
Different types of thermometers can be used, including standard fluid-filled, min-max, and continuous chart recorder thermometers to monitor vaccine storage temperatures. Standard fluid-filled thermometers are simple and least expensive, but some models might perform poorly. Product temperature thermometers (i.e., those encased in biosafe liquids) might reflect vaccine temperature more accurately. Min-max thermometers monitor the temperature range. Continuous chart recorder thermometers monitor temperature range and duration and need to be recalibrated at specified intervals. All thermometers used for monitoring vaccine storage temperatures should be calibrated and certified by an appropriate agency (e.g., National Institute of Standards and Technology). In addition, temperature indicators or ColdMark™ can be considered as a backup monitoring system; however, such indicators should not be used as a substitute for routine readings and documentation.
All medical professionals who administer vaccines should review their cold chain maintenance and management to ensure that 1) designated personnel and backup personnel have written procedures and are trained in vaccine storage and handling; 2) precision thermometers are placed properly in all vaccine storage units and any limitations of the storage system are fully known; 3) vaccines are stored properly within the refrigerator or freezer in which proper temperatures are maintained; 4) temperature logs are reviewed for completeness and any deviations from recommended temperature ranges; 5) any out-of-range temperatures prompt immediate action to fix the problem, with results of these actions documented; 6) any vaccine exposed to out-of-range temperatures is to be marked "DO NOT USE" and isolated physically from good vaccines; 7) when a problem is discovered, the exposed vaccine is maintained at proper temperatures while state or local health departments or the vaccine manufacturers are contacted for guidance; and 8) written emergency retrieval and storage procedures are in place in case of equipment failures or power outages. A 24 x 7 monitoring arrangement, such as a wireless temperature monitoring and alarm system, might be considered to alert staff to after-hours emergencies, particularly if large vaccine inventories are maintained.
Case Study
Safeguards Precious Pharmaceuticals
“DeltaTRAK FlashLink Wireless System helps us monitor and significantly minimize loss of expensive, environment-sensitive pharmaceuticals. The system’s reporting functions assist us in preparing for rigorous state and FDA audits and meeting pharmaceutical compounding and dispensing regulations.”
- Art Whitney, president of Pacific West Pharmacy (PWP) and owner of Advantage Pharmaceutical Inc. (API) of Rocklin, California.
Founded in 1987 and late 2004 respectively, PWP and API service Long Term Care facilities and hospitals throughout California. PWP dispenses prescription drugs and API specializes in compounding custom medications unavailable commercially. FDA and US Pharmacopoeia 797 regulate and annually audit environmental controls in pharmacies and pharmaceutical compounding facilities / cleanrooms, hence why accurate and reliable environmental monitoring solution is critical.
Advantage Pharmaceuticals Compounding Lab
"We used to hand note data on sheets of paper everyday including weekends, now the process is automated... with alarm-notification..."
FlashLink Wireless System monitors Advantage Pharmaceuticals’ compounding lab and PWP pharmacy’s temperature & humidity levels
Troy Whitney, PWP/API Information Technology Manager, began searching for an economical, real-time, wireless solution after regulatory audits found the manual method has shortcomings in tracking temperature and humidity data.
PWP/API chose DeltaTRAK’s FlashLink Wireless System. After carefully evaluating several other wireless monitoring products that proved to be unsatisfactory, Troy worked with DeltaTRAK to determine the best solution for meeting his regulatory, technical and financial requirements. PWP/API purchased the FlashLink Wireless System in July 2005 to record temperature / humidity in medication refrigerators and clean rooms. The FlashLink Wireless System installed by Troy in two separate buildings includes one 900 MHz receiver with PC interface unit and server software, three repeaters and seven wireless temperature & humidity sensors.
"We used to hand note data on sheets of paper everyday including weekends,” says Troy, “now the process is automated and I get real-time information displayed on my computer with multiple alarm-notification options. In addition, the data management and reporting capabilities make record compilation for regulatory audits simple. The DeltaTRAK wireless system not only makes my job much easier it, also quickly justifies our investment by helping us efficiently monitor the environmental conditions of compounded medications worth from $100,000 to $200,000. This leads to improvement in our overall operating efficiency."
Since installation, the 21 CFR Part 11 compliant FlashLink Wireless System has performed, 24 x 7, to PWP/API’s environmental monitoring specifications. PWP/API is looking to expand the system to monitor other environment-critical areas of their buildings. The wireless system manages up to 100 temperature and/or humidity sensors and, with the addition of the new Wireless SP Manager software, provides users with 24 x 7 information access from anywhere in the world.
Established in 1989, DeltaTRAK, Inc. is a California-based leading manufacturer and marketer of portable environmental testing and measurement systems used in healthcare, food and other major industries.
