Safe products start with safe plasma
Our history and proven track record of viral safety are a function of a highly rigorous process that begins with our raw material, human plasma. All blood donors, collection centres, and donated blood are held to the highest standards.
Plasma Collection Centres
All products destined for Canadian veins are manufactured exclusively from US source plasma obtained through Octapharma owned US collection centres. Octapharma Plasma, Inc (OPI) headquartered in Charlotte, NC is a fully owned subsidiary of Octapharma AG and collected approximately 3 million litres of Normal Source Plasma in 2012. In the US and the EU, plasma collection centres are routinely inspected and FDA, EMEA approved. In Canada, collection is managed by Canadian Blood Services and Héma-Québec, and is subjected to Health Canada standards.
Donors themselves must undergo a comprehensive up front and ongoing review process. Prior to each donation, donors are assigned a unique ID, and registered in the Octapharma donor database. A deferral check is conducted, and a detailed health history is taken. An accredited healthcare professional then provides an overall assessment, and may choose to exclude any donor that does not meet the acceptance criteria.
Donated Plasma Screening
Once received from the collection centres, all donated plasma undergoes individual unit testing for antibodies against HIV-1/2, HBV, HCV and syphilis. Plasma also undergoes PCR (NAT) testing for HIV, HBV, HCV and parvovirus B19. The result of this process is an exceptionally pure, high quality fresh frozen plasma (FFP) product.
Virus Inactivation/Prion Removal
- Single FFP units are combined and retested for HBV, HIV-1/2, HCV, and B19.
- Following this, approved plasma is subjected to the Solvent-Detergent process, which is the current gold standard for safety from highly infectious enveloped viruses.
- A meticulous chromatography and filtration process or alternative process removes further viral contaminants including prions. The type of process used varies according to the product being produced but the end goal remains the same.
- Finished products may be aseptically freeze dried into a powder form and placed into vials or packaged as solutions for infusion.
- PermaHeat or an alternative process is applied as an effective means to inactivate both enveloped and non enveloped virus.
- Finally, finished goods are subjected to our rigorous scientific Quality Control process as well as Health Canada testing before being released into the market.