What Matters Most : People
Products & Services : Bioscience : Our commitment to safety
   We make safety our concern, for your peace of mind

    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
    • Identification and verification by barcodes
      Full traceability from donation to final product.
    • 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.
    • 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.
    • Inventory-hold and look-back
      Every unit of plasma is held in inventory for at least 60 days before being released into production.
    • Final computer verification
      The only way plasma is released.

    Manufacturing
    • ELISA and NAT testing in fractionation pool
      As an added safety measure.
    • Pathogen elimination steps
      For maximum safety of the final product.
    • Specialized staff continuously updating their skills and expertise
      Confidence in a product requires trust in the people who make it.
    • Specific product biochemical features and formulation
      To enhance the safety profile.

    Patient
    • Unique laser etched identifier number
      Helps deter tampering.
    • Pharmacovigilance
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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