Introduction:

To maintain biological activity and avoid degradation of a product, strict conditions of collection and storage must be maintained, the information that supports the time and storage conditions must be based on long-term stability studies carried out in real time and storage conditions.

Objective:

To evaluate the shelf life stability and stress conditions of the platelet rich plasm obtained in an open system.

Methods:

A stability study was designed following the standards described by the Center for State Control of Medicines, where the main physicochemical and biological properties of platelet rich plasm were evaluated, the tests to demonstrate product stability were carried out with a duration of three days. and a test frequency at 0, 4, 8, 12, 24, 48 and 72 hours.

Results:

The pH tests showed that it remains stable regardless of time and temperature with 95% reliability, 100% reliability. The samples studied did not present variation in relation to the organoleptic characteristics and volume, sterility in general did not show variations either, platelet rich plasm concentrations according to time and temperatures showed a significance greater than 0.05 with variation depending on time and temperatures with a reliability of 95%.

Conclusions:

The present work shows that the platelet rich plasm elaboration process is carried out in a controlled and safe way, the platelet rich plasm obtained maintains its physical, chemical and biological properties after subjecting it to different storage times and temperatures.

        · resumen en Español     · texto en Español     · Español ( pdf )