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VariZIG™ is made from the antibodies of carefully selected plasma donors. Strict precautions are taken to screen and test donors and their plasma for potentially infectious agents such as viruses. Any donor or donation that does not fully meet the current safety standards is rejected.
The potential to transmit viruses through plasma products cannot be totally eliminated; however, the many precautions taken in the manufacture of VariZIG™ ensure that such risks are significantly reduced.
- Potential donors are initially evaluated before entering the program.
- A screening process is carried out prior to each donation.
- Every unit of plasma collected is tested for key infectious diseases including HIV, hepatitis B and hepatitis C and must be negative for these viral markers.
- All soft goods are strictly one use only and are destroyed after use.
The manufacturing process of VariZIG™ includes both a Planova 35 nm virus filter, which effectively removes lipid-enveloped and non-enveloped viruses based on size, and a solvent/detergent treatment step that effectively inactivates lipid-enveloped viruses. These two processes are designed to increase product safety by reducing the risk of viral transmission of several viruses including human immunodeficiency virus (HIV), hepatitis B and hepatitis C. However, despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products.
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