SAFETY of JBP Placental Extract (Human)
Safety Criteria of JBP Placental Extract (Human)
- Donor Screening
- Acceptance Inspection Test
- Sterilization by 3 Different Methods
- Product Specification Test
- Tested Negatives for all virus & bacteria tests including HBV, HCV, HIV, Treponema pallidum etc.
- Screening of Donor’s overseas staying experience
- Donor consent to use as a pharmaceutical ingredient
Acceptance Inspection Test
- Individual inspection by weight, color, smell, etc.
- NAT testing for HBV-DNA, HCV-RNA, HIV-1-RNA of all samples.
Sterilization by 3 Different Methods
- With organic solvent (acetone)
- With digestive enzyme + acid processing
- With 121℃ × 20 minutes autoclave (final sterilization)
Product Specification Test
Before approved for shipment, the product must show “negative” for:
Sterilizaion, combining several different mechanisms
Viral test at contracted obstetricians, re-tested at factory
Viral test of finished product