Integrated Safety System
- Donor Selection
Virus Inactivation/Removal & Prion Removal
Pharmacovigilance & Traceability
Plasma safety starts with careful donor selection. Donation centers for source plasma are monitored by the company itself, by the Plasma Protein Therapies Association (PPTA) and by regulatory agencies to ensure compliance with established standards. For each plasma collection center, the rate of positive tests -- indicating the presence of viruses -- on all plasma donations collected is assessed on a regular basis. The viral marker rates may not exceed a maximum number of confirmed positive donors for HIV, HCV and HBV, as currently defined by PPTA’s viral marker standard.
All potential donors undergo an initial physical examination before
donating plasma and complete in-depth questionnaires about their medical history and lifestyle, including high-risk behavior. Those individuals who do not meet the rigorous requirements required to donate plasma are deferred and may not donate.
Only after donors have returned for a second donation within a six-month period, and have again tested negative, will their first donation be released for further processing. Such donors are then classified as qualified donors and can typically donate regularly, with continued monitoring of their health through physical examinations, vital signs and health questionnaires. If a donor no longer meets safety and quality criteria, the donor is permanently deferred.