BDI Pharma, LLC.
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BDI Pharma is a Verified-Accredited Wholesale Distributor  one of 34 active members of the HDMA, and a member of HISCI.   Always rest assured your product is being handled with the utmost care and professionalism.
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Effective April 1, 2012 through June 30, 2012. Visit the Centers for Medicare & Medicaid Services for more information.


Viral Safety Information
IVIG 
Product  Viral Inactivation Process  Viral Removal Process 
Carimune NF Nanofiltered  pH 4 in presence of pepsin,   Nanofiltration  
Gamunex  Caprylate   chromatography purified 
Flebogamma 5%   Pasteurization   PEG Precipitation 
Octagam  Solvent / Detergent
(tnBP + Triton X - 100) + pH4 incubation for 24 hours  		 N/A 
Gammagard S/D   Solvent / Detergent    
Gammagard Liquid   Solvent / Detergent
low pH incubation at elevated temperature 		 35nm nanofiltration 
WinRho SDF   Solvent / Detergent   Nano-Filtration 
Cytogam  Cohn-Oncley cold ethanol fractionation and treated with Solvent / Detergent procedure   N/A 
 
Coagulation Factor 
Anti-Hemophilic Factors VIII 
Product  Viral Inactivation Process  Viral Removal Process 
Helixate FS   Solvent / Detergent Treatment   Monoclonal Antibody
Immuno-Affinity Chromatography 
Kogenate FS   Solvent / Detergent Treatment   Monoclonal Antibody
Immuno-Affinity Chromatography 
Recombinate   N/A  Immuno-Affinity Chromatography and Ion Exchange Chromatography  
Advate  Solvent / Detergent Treatment   Immuno-Affinity Chromatography and Ion Exchange Chromatography  
Humate-P  Pasteurization  Absorption and Precipitation Process  
Monarch-M  Solvent / Detergent Treatment   Monoclonal Antibody
Immuno-Affinity Chromatography  
Hemofil M   Solvent / Detergent Treatment   Monoclonal Antibody
Immuno-Affinity Chromatography  
Monoclate-P   Pasteurization  Monoclonal Antibody
Immuno-Affinity Chromatography  
Koate-DVI   Solvent / Detergent
Heat treatment 80C x 72 Hours 		 N/A 
Alphanate  Solvent / Detergent with a mixture of Tri(nbutyl)phosphate (TNBP) and Polysorbate 80 / Dry Heat Cycle at 80C for 72 hours. Lyophilization.   Affinity Chromatography heparin-coupled agarose which has an affinity to the heparin binding domain of vWF/F VIII: C Complex, 3.5% PEG Precipitation 
     
Anti-Hemophilic Factors VIIa & XI Anti-Inhibitor 
Product  Viral Inactivation Process  Viral Removal Process 
NovoSeven  N/A  Chromatographic Purification Process to remove exogenous viruses 
Feiba VH   Vapor Heat Treatment 60 C 10 hrs, 190mbar., then 80 C 1 hour, 370mbar.   N/A 
Mononine  Sodium Thiocyanate   Monoclonal Antibody Immunoaffinity Chromatography and Ultrafiltration  
AlphaNine SD   Solvent / Detergent Treatment with a mixture of Tri (n-butyl) phosphate (TNBP) and Polysorbate 80   DEAEChromatography/Dual Affinity
Chromatography / Nanofiltration  
Bebulin VH   Vapor Heat Treatment 60 C 10 hrs, 190mbar., then 80 C 1 hour, 375mbar.  N/A 
Profilnine SD   Solvent / Detergent Treatment with a mixture of Tri (n-butyl) phosphate (TNBP) and Polysorbate 80   DEAE Chromatography  
     
Hyper-Immunes & Injectables 
Product  Viral Inactivation Process  Viral Removal Process 
GamaSTAN S/D   Solvent / Detergent
Heat Treated  		 Ultrafiltration 
Rhophylac  Solvent / Detergent   Nanofiltration /
Ion-Exchange Chromatography 
HyperRHO S/D   Solvent / Detergent
Heat Treated  		 Ultrafiltration 
WinRho SDF   Solvent / Detergent treatment - inactivation of enveloped viruses   Nano filtration - viral removal  
HyperHEP B S/D   Solvent / Detergent
Heat Treated  		 Ultrafiltration 
Nabi - HB   Solvent / Detergent treatment - inactivation of enveloped viruses   Viral filtration - viral removal  
HyperRAB S/D   Solvent / Detergent
Heat Treated 		 Ultrafiltration 
Rabavert    The rabies vaccine works by promoting active immunity through induction of an active immune response. The production of specific antibodies requires 7 to 10 days to develop.  
HyperTET S/D   Solvent / Detergent
Heat Treated 		 Ultrafiltration