Grifols USA

What Matters Most : People

Products & Services : Bioscience : Our commitment to safety

Manufacturing : State-of-the-art facilities with a highly qualified team

Grifols' specialized staff continuously update their skills and expertise. This enables us to evaluate and utilize innovative new technologies in plasma testing and production processes in order to achieve the highest levels of safety.

ELISA and NAT testing in the fractionation pool prior to manufacturing

Once accepted for production, individual units of plasma are combined into a larger fractionation pool. Fractionation pools are then tested, once again using ELISA for HIVAb, HBsAg and HCVAb and NAT techniques for HIV-1 and HCV.

The manufacturing process includes several steps for maximum safety of the final product

Specific pathogen elimination steps are deliberately introduced into the manufacturing process as an additional safety measure (i.e. Heat treatment, Pasteurization, Solvent Detergent or Nanofiltration).
Non-specific pathogen elimination steps are purification steps which form part of the production process and have demonstrated capability to eliminate pathogens (i.e. Affinity Chromatography).

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.

Donor

Plasma Testing

Manufacturing

Patient

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