Validation of current commercially-available devices to thaw pooled, solvent/detergent-treated human plasma.

Abstract

Background: Proper thawing procedures are required to preserve the quality of human fresh frozen plasma (FFP). octaplasLG (Octapharma AG, Switzerland) is a frozen solution of solvent/detergent (S/D)-treated human plasma, produced to improve pathogen safety. This study aimed to validate the S/D plasma thawing process using the latest-generation of commercially-available thawing devices and to determine S/D plasma quality after thawing.

Study design and methods: Thawing of S/D plasma units was investigated using a microwave oven (Transfusio-therm 3000) and dry tempering systems (SAHARA 4 and Plasmatherm V). Times to defrost plasma and reach 30°C product temperature, using the 37°C thawing programmes, were defined for all devices. Thawed S/D plasma units were tested against product release parameters, as well as for hemostatic capacity tested indirectly via global coagulation parameters, coagulation factors, protease inhibitors and markers of activated coagulation.

Results: The fastest thawing was observed using the microwave oven; S/D plasma units were defrosted after 2-3 min. All S/D plasma units thawed by the different devices using optimised thawing conditions were clear and free of solid and gelatinous particles, indicating no local overheating or protein denaturation. Coagulation factor and inhibitor activities and hemostatic capacity of S/D plasma were comparable when thawed by the three different devices. With each device, all product parameters were within product release specification levels after thawing.

Conclusions: S/D plasma can be thawed using the Transfusio-therm 3000, SAHARA 4 or Plasmatherm V thawing devices using the optimised settings defined for this plasma product, with no negative influence on plasma quality.