Background:
You are a member of a project team at Quality Chemicals, Inc. Quality Chemicals is a moderately sized chemical company with $200 million in annual sales. Quality has both continuous as well as batch manufacturing capabilities, but their batch manufacturing assets are currently underutilized. The Quality manufacturing facilities were recently inspected by the FDA and found to meet all good manufacturing requirements (GMP) to product bulk pharmaceuticals.
Your team is in the process of evaluating two new product opportunities from Pfizer Pharmaceuticals. One of the products is an active ingredient for an existing Pfizer product which has five years of exclusivity left on its patent before it goes generic. The drug substance is used in the cough and cold market and the annual requirement is about 150 metric tons, although the profit margin is only 5% (fully allocated).
The second product is a key intermediate for a developmental drug to treat deep vein thrombosis. The synthesis of the compound presents significant technical challenges, but the profit margin is projected to be in excess of 35% (fully allocated). The drug is in Phase III of drug development and is projected to launch within 24 months, which means you will need to produce the intermediate within 12 months in order for Pfizer to complete the synthesis and formulate the product for launch. There are two applications for this drug. One is an acute application with is projected to be about 10 metric tons annually. The second is for a chronic application which is about 85 metric tons annually. Pfizer expects to receive approval for the acute application first within 24 months. However, the chronic application will require additional clinical testing and will not be approved for approximately four years.
1. (20%) The cough and cold product is a two-step process. In the first reaction, three reagents are added to the reactor simultaneously. One of the reactants is HCl gas, another is malononitrile and the third is para-nitrobenzaldehyde. The market volume requires the use of a 6,000 liter reactor. The reaction mixture is the rapidly heated for six hours at 115°C with tight temperature control. The second step is a hydrogenation in which a nitro group is reduced and must be carried out at -15°C under strongly alkaline (pH 12) and requires a 4,000-liter reactor. In both cases, the reaction products are crystallized, isolated by centrifugation and dried. Please provide the following information:
– Process flow diagram that includes both reactions
– Materials of construction for all equipment
– Factored capital estimate for ALL equipment components to produce the cough and cold product (use installation factor of 3.2)
– Summary of results for your process hazard review (tests required, special chemical precautions, personal protective equipment, etc.)
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