Negatives for all virus & bacteria tests
Screening by Donor’s overseas stay experience
Consent by Donor
2.Acceptance Inspection Testing
3.Sterilization by 3 Different Methods
4.Product Specification Testing for Viruses
Donor must show “negative” for all of:
in addition to: treponema pallidum, gonorrhea, TB, etc.
To minimize probability of exposure to BSE, Donor must not have stayed in any of 7 European countries for 6 months+ (1 day+ for United Kingdom & France) since January 1980.
1.With organic solvent
2.With digestive enzyme+acid processing
3.With 121℃×20 minute autoclave (finalsterilization)
All sterilization methods and processes are validated by spiking.
Viral testing at contracted
re-tested at factory
Viral testing of finished