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