SAFETY of JBP Placental Extract (Human) Read more
– Safety Scheme of JBP Placental Extract (Human)
Donor Screening
Negatives for all virus & bacteria tests
Screening by Donor’s overseas stay experience
Consent by Donor
Acceptance Inspection Testing
Sterilization by 3 Different Methods
Product Specification Testing for Viruses
– Donor Screening + Donor’s Consent
Virus & Bacteria Testing
Donor must show “negative” for all of:
HBV
HCV
HIV
in addition to: treponema pallidum, gonorrhea, TB, etc.
Donor’s Overseas Stay Experience
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.
Acceptance Inspection Testing
Individual inspection by weight, colour, smell, etc.
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NAT testing for HBV-DNA, HCV-RNA, HIV-1-RNA of all samples.
Virus testing methods are all validated accordingly.
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Accepted
Sterilization Employing 3 Different Methods
With organic solvent
With digestive enzyme+acid processing
With 121℃×20 minute autoclave (final sterilization)
All sterilization methods and processes are validated by spiking.
Product Specification Testing for Viruses
HBV
HCV
HIV
HTLV
Parvovirus-B19
Product specification testing must show “negative” for all 5 viruses above, before approved for clearance.Testing methods and procedures are all validated by spiking of respective viruses.