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Grifols's extensive plasma derivatives safety program includes a rigorous
methodology, cutting edge technologies, experienced staff and full traceability
from plasma donation to final product (www.pedigrionline.net ).
From donor to patient.
Donor
Plasma Testing
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Identification and verification by barcodes
Full traceability from donation to final product.
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Immunoassay (ELISA) testing for each donation
Each unit is tested by enzyme linked immunoabsorbent assay (ELISA) for HBsAg,
HIVAb, and HCVAb. ELISA is a serologic test that links a measurable enzyme to
virus antibodies or antigens.
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Minipool Nucleic Acid Testing (NAT)
Each unit is screened using Nucleic Acid Amplification Testing (NAT) for HIV-1
and HCV after pooling small aliquots from not more than 512 units (minipool).
NAT is a highly sensitive test that can detect small virus amounts.
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Inventory-hold and look-back
Every unit of plasma is held in inventory for at least 60 days before being
released into production.
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Final computer verification
The only way plasma is released.
Manufacturing
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ELISA and NAT testing in fractionation pool
As an added safety measure.
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Pathogen elimination steps
For maximum safety of the final product.
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Specialized staff continuously updating their skills and expertise
Confidence in a product requires trust in the people who make it.
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Specific product biochemical features and formulation
To enhance the safety profile.
Patient
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Unique laser etched identifier number
Helps deter tampering.
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Pharmacovigilance
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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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