Quality Regulations

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Our entire process is regulated by our quality standards.

Product Storage

Frozen plasma is stored on site in the donation centers, and tracked while the plasma samples are tested. If problems are found, the product is rejected. The Quality Group assures that only units that pass are sent on for manufacturing.


Product Testing

Many tests are performed to safeguard the patients who have a need for the products produced from plasma donations. The plasma is tested for Syphilis, Alanine Amino Transferase (ALT), Hepatitis B & C, HIV. Other tests will be performed as needed.

Regulatory authorities check each lot before approving it for release. When the plasma reaches the fractionation plant, it is further tested and sterilized before being manufactured into therapeutic products.