JBP 태반추출물의 안정성(Human)

JBP 태반추출물의 안정성(Human)

■ .JBP 태반 (人)의 안전성 확보 개요

1.기증자 선별

기증자의 바이러스 • 세균 감염 테스트
기증자의 해외 체류 경험에 의한 선별
의약품 원료로 사용하기에 기증자의 동의
1.선반 수입시에 실시하는 검사

1.서로 다른 세 가지 방법으로 멸균 공정
2.바이러스에 대한 제품 적합성 시험.

■ 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

Individual inspection by weight, colour, smell, etc.

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

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

(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

(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