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Utilizing the latest safety measures
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Grifols has a separate company solely dedicated to the quality and safety of
plasma.
Identification and verification by barcodes to ensure full traceability
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All donations are cross-referenced with their certificates of analysis,
previously recorded in Grifols' computer system.
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All test results, including viral marker tests, are verified on all donations
once they are received from the donation centers.
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Visual and computerized checks are performed on all donations.
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Only inspected donations that are fully traceable are accepted.
ELISA and NAT testing
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Plasma donations are tested individually by Enzyme Linked Immunoabsorbent Assay
(ELISA) for HBsAg, HIVAb and HCVAb.
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Each unit is screened in minipools of ≤ 512 units using Nucleic Acid
Amplification Technique (NAT testing) for HIV-1 and HCV. Minipool NAT testing
allows for specific identification and isolation of a single questionable
donation for removal prior to production
Inventory-hold and look-back - an additional safety measure
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All plasma donations are stored for a minimum of 60 days before being used in
production. This inventory-hold gives Grifols the opportunity to reject
donations of any donor rejected because of a seroconversion in subsequent
donations (look-back).
Final computer verification, the only way plasma is released
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Each donation is computer checked again before it is sent for plasma
derivatives production which guarantees that each donation has satisfied all
controls.
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Grifols has been awarded the PPTA's Quality
Standard of Excellence Assurance and Leadership (QSEAL) certification
The certification is an acknowledgement of the company's rigorous selection of
its donor centers and donors as well as its careful testing of each plasma unit
prior to its being used to make plasma products.
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Important Safety Information:
As with all plasma-derived products, the risk of transmission of infectious
agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease
(CJD) agent, cannot be completely eliminated. |
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