Evaluation of the Sterility of PRP Obtained with Multi-bag System (PRPBAG®)

Abstract

Introduction: The aim of this study is demonstrating the sterility of PRPBAG®, a multi-bag completely closed PRP preparation system different than PRP kits in the market and determining preservability of the sterility of PRP produced with PRPBAG® up to 5 days similar to other platelet products. Methods: We recruited 60 participants for increased statistical significance. 150 mL of whole blood was collected in specially produced PRPBAG®. A double-spin preparation method was used for the samples with a refrigerated centrifuge specially manufactured for PRPBAG®. We started centrifugation within 1 h after collecting blood. In the 1st spin of the centrifugation, whole blood was centrifuged. Erythrocytes precipitated in the first bag because of blood component density, and the supernatant plasma was transferred into the second bag using a manual plasma extractor. The third bag was empty after the first spin. We used a hose-closing device to separate the first bag, which contained erythrocytes, from the other bags. In the second spin of centrifugation, the plasma was centrifuged. Results: PRP product with high-quality was collected in the second bag. We have considered the European guidelines for the preparation, use, and quality assurance of blood components during the whole process. 1 cc of PRP was added into separate pediatric blood culture bottles on days 0, 1, 2, 3, 4, and 5. These samples were sent to the microbiology laboratory and incubated for 5 days. After this incubation period, the blood culture bottles that did not give positive signals were reported as sterile. Conclusion: Currently, PRP is used immediately after preparation. Our study demonstrates that PRP prepared with a closed triple blood bag system PRPBAG® may be used for 5 days if agitated at room temperature. There was not any bacterial growth in any sample after 5 days.