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It is hereby certified that LAENNEC injection is manufactured, taking the measures
against viral contamination as outlined below, by JAPAN BIO PRODUCTS Co., Ltd.,
at 1-44-4 Tomigaya, Shibuya-ku, Tokyo, Japan 151-0063.
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Safety Protocol on LAENNEC Injection It is hereby certified that LAENNEC injection
is manufactured, taking the measures against viral contamination as outlined below,
by JAPAN BIO PRODUCTS Co., Ltd., at 1-44-4 Tomigaya, Shibuya-ku, Tokyo, Japan 151-0063.
1. Safety Scheme of JBP Placental Extract (Human)
1. Donor Screening & Donor’s Consent.
Negatives for all virus & bacteria tests.
Screening by Donor’s overseas stay experience
2. Acceptance Inspection Testing
3. Sterilization by 3 Different Methods
4. Product Specification Testing for Viruses
2. Donor Screening & Donor’s Consent
(1) Virus & Bacteria Testing
Donor must show “negative” for all of:
① HBV ② HCV ③ HIV ④ HTLV ⑤ Parvovirus-B19
in addition to: treponema pallidum, gonorrhea, TB, etc.
(3) 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.
Donor’s Consent
２. Acceptance Inspection Testing
Individual inspection by weight, color, smell, and overall observation
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NAT testing for HBV-DNA, HCV-RNA, HIV-1-RNA of all samples.
Virus testing methods are validated accordingly.
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Accepted
３. Sterilization Employing 3 Different Methods
① With organic solvent
② With digestive enzyme + acid processing
③ With 121℃×20 minute autoclave sterilization
All sterilization methods and processes are validated by spiking.
４. Product Specification Testing for Viruses
Product specification testing must show “negative” for all
5 viruses below, before approved for clearance:
① HBV
② HCV
③ HIV
④ HTLV
⑤ Parvovirus-B19
Testing methods and procedures are validated by spiking of respective viruses.
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