C O M M I T M E N T T O S A
F E T Y
STRINGENT
PLASMA TESTING
Plasma from sero negative donors, immunized with Hepatitis
A and Hepatitis B vaccine, is collected by means of
auto–plasmapheresis.
- 5
times of EIA (Enzyme–linked Immuno–sorbant
Assay) testing, using imported test kits approved
by either the
 USFDA
or the Paul Ehrlich Institute of Germany, for Hepatitis
B surface Antigen (HBsAg), Hepatitis C Virus (Anti–HCV),
and Human Immunodeficiency Viruses 1 and 2 (Anti–HIV
1 & 2).
- 3 times of NAT (Nucleic Acid Amplification
Test) testing for HBV DNA, HCV RNA and HIV RNA. We
use reference standards from USFDA or WHO for all
testing.
CAREFUL
REMOVAL OF BACTERIA AND VIRUSES
Protein Fractionation and Purification, a modified Cohn
method of cold alcohol fractionation is applied to prevent
any growth of microorganisms or contamination of pyrogenic
agents. We also use various sizes of filters to remove
viruses and bacteria at various temperatures to eliminate
the risk of product contamination.
VIRUS INACTIVATION
Each of our products undergoes at least two steps of
virus inactivation. Certain products undergo three or
more steps of virus inactivation. In each case, we apply
- Solvent Detergent
- Pasteurization
- Heating
- Chromatographic Step
- Depth Filtration
- Nano Filtration
A
combination of these methods is used to achieve a quality
level beyond standard requirements.
SAFETY
RECORD
Retrospective clinical surveys of 8 Million vials of
various products have been used. Not one single case
of adverse reaction nor virus contamination has been
reported to date, either from within China or other
countries around the world. Our reputation has been
well established due to the high quality and safety
of our products during the 12 years of our presence
in China.
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