How should Octaplasma® be stored? What is to be done in the event of a temperature excursion?
A: Octaplasma® should be stored and maintained frozen until use (< -18 °C).3
In the event of a temperature excursion, hospitals will need to contact Canadian Blood Services who will then forward the case to Octapharma Canada for assessment. The assessment will be done by Octapharma QA team and will determine next steps on a case-by-case basis.
How should Octaplasma® bags be thawed?
If using a water bath, thaw with the outer wrapper intact for no less than 30 minutes in a circulating water bath at +30 °C to +37 °C. The minimum thawing time is 30 minutes at 37 °C. The thawing time depends on the number of bags in the water bath. If more plasma bags are thawed in parallel, the thawing time can be prolonged, but should not be longer than 60 minutes.
If using a dry tempering system such as the SAHARA-III, place the Octaplasma® bags on the agitation plate according to the manufacturer instructions and thaw plasma using the fast-tempering function. When +37 °C blood component temperature is indicated on the temperature display, terminate the tempering process, and remove the bags. It is recommended to use the protocol printer to record the course of the blood component temperature and, error messages in event of failure.
Other thawing systems for frozen Octaplasma® can be used on the condition that the methods are validated for that purpose.
Below is a guide on the appearance of thawed Octaplasma ® bags and when a bag would be considered safe to transfuse:
Why is Octaplasma® referred to as S/D plasma?
A: Octaplasma® manufacturing employs a process called Solvent/detergent (S/D) treatment. S/D treatment was pioneered by Octapharma and is an established virus inactivation technology that has been industrially applied for manufacturing plasma derived medicinal products for almost 30 years. It is considered as the gold standard for pathogen inactivation of lipid enveloped viruses. Many clinical studies have confirmed its safety and efficacy in the setting of congenital as well as acquired bleeding disorders.2
What is Octaplasma®?
A: Octaplasma® is standardized human plasma for intravenous administration. It is a Health Canada regulated medicinal product for human use.
Octaplasma® is made from pooled plasma collected from donors in the United States.1 The Octaplasma® manufacturing process ensures that each bag of plasma has standardized content of clotting factors and proteins. It is devoid of antibodies implicated in transfusion-related acute lung injury (TRALI) pathogenesis and employs multiple dedicated steps to eliminate transfusion-transmissible infectious agents, allergic and citrate reactions.2 Octaplasma® is manufactured by Octapharma AB in Stockholm, Sweden.3
