A project requires weighing and dispensing of multiple hi-potent (ECL>3) pharmaceutical compounds in powder form for...

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Mechanical Engineering

A project requires weighing and dispensing of multiple hi-potent(ECL>3) pharmaceutical compounds in powder form for ablockbuster, commercially marketed drug, itâ€™s a sterile processingplant. Provide your conceptual HVAC design description that includeprimary enclosures (only HVAC for handling and transfer devices)and secondary (room/HVAC) containments to protect productattributes (integrity, efficacy, purity), personnel fromenvironmental exposures. Elegant, energy efficient, and least costdesign URS solution are required criteria. A project requiresweighing and dispensing of multiple hi-potent (ECL>3)pharmaceutical compounds in powder form for a blockbuster,commercially marketed drug, itâ€™s a sterile processing plant.Provide your conceptual HVAC design description that includeprimary enclosures (only HVAC for handling and transfer devices)and secondary (room/HVAC) containments to protect productattributes (integrity, efficacy, purity), personnel fromenvironmental exposures. Elegant, energy efficient, and least costdesign URS solution are required criteria.

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What can HVAC do HVAC system performs four basic functions 1 Control airborne particles dust and microorganisms Thru air filtration using high efficiency particulate air HEPA filters 2 Maintain room pressure delta P Areas that must remain cleaner than surrounding areas must be kept under a positive pressurization meaning that air flow must be from the cleaner area towards the adjoining space through doors or other openings to reduce the chance of airborne contamination This is achieved by the HVAC system providing more air into the cleaner space than is mechanically removed from that same space 3 Maintain space moisture Relative Humidity Humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers Humidity can affect the efficacy and stability of drugs and is sometimes important to effectively mould the tablets 4 Maintain space temperature Temperature can affect production directly or indirectly by fostering the growth of microbial contaminants on workers Each of above parameter is controlled and evaluated in light of its potential to impact product quality What HVAC cant do 1 HVAC can not clean up the surfaces of a contaminated surfaces room or equipment 2 HVAC can not compensate for workers who do not follow procedures We will learn about the specific design aspects later in this course but first we will briefly discuss the generic pharmaceutical process Pharmaceutical Process The task of the pharmaceutical manufacturer is to combine the medicinally active agents provided by a fine chemicals plant or by extraction from vegetable animal or other source with suitable inactive ingredients so that the end product may be used in the correct dosage to produce the effect needed Simplified Process Figure below illustrates a simplified diagram of the chemical synthesis process for pharmaceuticals There are five primary stages in chemical synthesis 1 reaction 2 separation 3 crystallization 4 purification and 5 drying Each of these five stages is described below Reactions In the reaction process raw materials are fed into a reactor vessel where reactions such as alkylations hydrogenations or brominations are performed The most common type of reactor vessel is the kettletype reactor generally made See Answer

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