14. Describe an Injectable Liquid Manufacturing Process 15. Describe a o7 Good M

Question

14. Describe an Injectable Liquid Manufacturing Process 15. Describe a o7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients 16. What are the point to consider in Process Equipment using GMPs, give an example applied to Pharmaceutical/Biopharmaceutical industry 17. In a typical biotech manufacturing Process, what is the significance of QSD? Explain brief what aspects include these item? 18. List and describe five HVAC system components in the pharmaceutical/biopharmaceutical manufacturing process 19. What is the “critical area" in the clean room and what are the limits for micro-contaminants for the class 100,000 and class 100 areas. 20. What is an airborne and the airborne viable limits for Class 100, 10,000, 100,000 Room Classification? 3. Plasmid instability in batch culture (Optional A plasmid-containing strain of E. coli is used to produce recombinant protein in a 300-liter fermenter. The probability of plasmid loss per generation is 0.0034. The specific growth rate of plasmid-free cells is 2.3 h, the specific growth rate of plasmid-bearing cells is 1.95 h. Estimate the fraction of plasmid-bearing cells after 18 h of growth if the inoculum contains only cells with plasmid

Explanation / Answer

Liquid Injection molding is used for making various products from stock material. Unlike conventional reaction injection molding it depends on mechanical mixing. This method is generally used for liquid silicone rubber and other elastomeric material. Liquid injection molding is very versatile due to the material properties of liquid silicone materials, like high flame and heat resistance, tensile strength and flexibility.

The Liquid injection molding system contains a delivery system which deliver the material to the injection molding machine. Usually two components, namely base forming plastic and catalysts for mixing is used. After mixing these two components in a static mixer it is injected into the mold and the finished product is obtained.

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