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BIOMEDICAL RESEARCH AND DEVELOPMENT
B Biomedical Product Development
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appropriate Approved assay autoclave Avenue Bethesda BioPharm Biotechnology CDER Center for Drugs chamber Chemical Clean Room Clinical components containers cycle Depyrogenation Device and Diagnostic Diagnostic Industry disinfectant DIVISION OF DIVISION DRUG ADMINISTRATION OFFICE Drug Products drug substance Drugs and Biologics drying effectiveness endotoxin ensure equipment eutectic point facility filter final product FOOD AND DRUG Guidelines HEALTH AND HUMAN HEALTH SERVICE FOOD heat HEPA HUMAN SERVICES PUBLIC Interpharm Press Journal of Parenteral Laboratory lyophilization manufacturing Manufacturing Practices Mary Ann Liebert Medical Device method microbial monitoring packaging Parenteral Science particulate Ph.D Pharmaceutical Engineering Pharmaceutical Technology procedures PUBLIC HEALTH SERVICE Qualification Quality Assurance Quality Control raw materials Regulatory requirements Research result reverse osmosis Rockville Pike routine safety sample Science and Technology Software specifications Standards steam sterilization storage temperature thermocouples tion vendor vials