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Donor selection

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UK/CORP/15-0012l. Date of preparation: July 2015
United Kingdom
Include All CSL Behring Country Sites

Donor Selection

Plasma safety starts with careful donor selection. Donation centres 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 centre, 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.

Donor Selection 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 behaviour. 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.

UK/CORP/15-0012b Date of preparation: July 2015