Understanding Regulations for Plasma Storage
Storing human plasma is one of the most strictly regulated parts of the cold chain. Governed by rules from the FDA and AABB, preserving these life-saving products requires a precise and verifiable environment. For blood banks, hospitals, and pharmaceutical companies, compliance is a complete system where the storage environment—and the data that proves it—is as important as the plasma itself.
The Temperature Imperative: FDA and AABB Mandates
At the heart of plasma storage rules are specific temperatures required by both the FDA and AABB. For standard long-term storage, plasma products must be kept at -18°C or colder for a typical one-year shelf life. For some products, like rare blood types, an extended shelf life of seven years is allowed, but this requires storage at an ultra-low temperature of -65°C or colder.
The rules get even stricter once plasma is thawed for use. A countdown begins, and the storage temperature changes from frozen to refrigerated. If not used right away, thawed plasma must be stored in a qualified blood bank refrigerator at a temperature between 1°C and 6°C. The FDA gives thawed plasma a strict 24-hour shelf life, after which the clotting factors can start to break down. However, AABB standards offer a way to extend this. If a thawed unit isn't used within 24 hours, it can be relabeled as "Thawed Plasma" and stored for another four days at the same 1°C to 6°C temperature, a key process for reducing waste.
Compliance Beyond the Thermometer: Alarms, Monitoring, and Calibration
Compliance is about more than just having a freezer set to the right temperature. Regulations require a full quality management system. This includes continuous automated monitoring, where electronic systems track the temperature of all storage units and record it at least every four hours. Every storage unit must also have audible and visual alarms that go off if the temperature goes out of range, and these alarms must be regularly tested and documented. Finally, all equipment must be formally qualified for use and all temperature-measuring devices must be regularly calibrated against national standards, with all of this activity documented. The complexity of these rules highlights the need for specialized knowledge of both FDA and AABB standards.
In a regulated field, the rule is simple: if it isn't documented, it didn't happen. The data from monitoring systems is just as important as the product itself. Good records are the main proof of compliance during an audit and must include temperature logs, alarm details, maintenance histories, and calibration certificates. The FDA and AABB only allow plasma to be issued without a physical inspection for thawing if there is a complete record of temperature monitoring. A failure in the data-logging system is a major compliance failure.