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At this years AABB CTTXPO 2010, Oklahoma Blood Institute is presenting an abstract about the benefits of using Platelet Manager^TM after two years of operation. The poster abstract is AP47, "Use Of Platelet Pheresis Software to Perform Product Qualification". The author is Marilyn Cutler, OBI's Director of Technical Operations.

The poster presentation will be from 6 PM to 7:30 PM. We cordially invite you to attend and see our solutions from a user's prespective.

Poster Abstract as Submitted:

Use Of Platelet Pheresis Software To Perform Product Qualification

Background:
Various factors influence the outcome of platelet pheresis products that must comply with both regulatory and manufactures specifications for release. These products must meet both platelet concentration and volume parameters to meet requirements for labeling and ultimately transfusion. With the advent of splitting products into multiple units the activities associated with this process are very onerous. To ensure a product meets the required specifications multiple calculations must be performed to ensure they meet acceptable product specifications.

Study:
A comparison of a manual system for platelet apheresis product qualification was compared with a software program Sigma Blood Systems Platelet Manager^TM. This study compared product failure rates, manufacturing efficiency and resource requirements between the manual and software systems. Data was compared from the manual system for a period of July 2007 to August 2008 and the software system between of August 2008 to March 2010.

Conclusion:
The total number of platelet pheresis products prepared was compared between the two systems.
The manufacturing process required intensive calculations to determine products that should be made based on platelet concentration and product volume. The software provided electronic splitting information based on pre-established logic tiers that eliminated the need for manual calculations during the product splitting activities. This process required staff to first determine product criteria and then manipulate the base product into acceptable sub products. The number of FTEs and the tasks required to perform platelet manufacturing were reviewed. The comparison of this process revealed that the use of Platelet Manager^TM increased productivity by 40%. Product quality control (QC) failure rates between the two systems were reviewed. . This review showed that the QC failure rate decreased to an average of 0.1% while utilizing the software as compared to the manual system. The investigation activities associated with failed QC were also reduced. The software aided in the tracking of the process and workflow while providing a comprehensive audit trail of all activities.