SAFETY of JBP Placental Extract (Human)

Safety Scheme of JBP Placental Extract (Human)

■ Safety Scheme of JBP Placental Extract (Human)

1.Donor Screening
   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 Screening + Donor’s Consent

Virus & Bacteria Testing

Donor must show “negative” for all of:

1.HBV
2.HCV
3.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

1.

Individual inspection by weight, colour, smell, etc.

2.

NAT testing for HBV-DNA, HCV-RNA, HIV-1-RNA of all samples. Virus testing methods are all validated accordingly.

3.

Accepted

■ Sterilization Employing 3 Different Methods

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. 

■ Product Specification Testing for Viruses

1.HBV 2.HCV 3.HIV 4.HTLV 5.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.

Sterilizaion, combining
several different
mechanisms

Viral testing at contracted
obstetricians,
re-tested at factory

Viral testing of finished
product

1-44-4 Tomigaya,Shibuya-ku,Tokyo,151-0063,Japan
TEL +81-3-3481-6061
FAX +81-3-3481-6065

Japan Bio Products Co., Ltd.

1-44-4 Tomigaya,Shibuya-ku,Tokyo,151-0063,Japan
TEL +81-3-3481-6061
FAX +81-3-3481-6065