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 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.
NAT testing for HBV-DNA, HCV-RNA, HIV-1-RNA of all samples.
Virus testing methods are all validated accordingly.
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 must show “negative” for all 5 viruses above, before approved for clearance.Testing methods and procedures are all validated by spiking of respective viruses.
Viral testing at contracted
re-tested at factory
Viral testing of finished