MANUF LEC: Commercial Manufacturing Part 1

A simple process used to separate two immiscible liquidsSeparatory funnelA simple process used for two miscible liquidsDistillationA simple process used for two solidsGarblingSimple processes used to separate solid from liquidCentrifugation, filtration, expressionA category of separation that requires the formation of a second phase by the addition of a liquid, solid, or gas plus mechanical manipulationComplex ProcessTrue or False: To separate ASA from salicylic acid (impurity), a solvent is added to the mixture to recrystallize only ASA, and the SA found in the solution is removed by discarding the filtrateTrueA separation process where an optically transparent liquid is obtained, which passes through a porous substance (filter/filtering medium)FiltrationThe liquid obtained in filtrationFiltrateTrue or False: Larger particles are harder to filter than smaller particlesFalseWhy are small particles harder to filter?- They have the tendency to occlude the pores of the bed, thus hinders passage of filtrate - The build up on the filter tends to form a non-porous, densely packed bed that resist passage of the filtrateUsed in filtration that has channels that impart porosityFiltering MediaDefined as being full of tiny holes that water or air can get throughPorosityThe ability of the filter medium to eliminate solid material from the liquidRetentionThe speed at which the purified liquid/filtrate is recoveredFiltration RateThe speed of the flow of the liquid through the filter bedFlow RateThis is retarded by the viscosity of the liquidFlow RateTypes of Filtering MediaFilter Paper Membrane Filters Cotton Filters Glass Wool Filters Sintered Glass FiltersType of filtering media similar to a cloth; pure or derived cellulose products with uniform micropore structure (10nm to 10um)Membrane FilterType of filtering media used in chemical, microbiological, and bacterial analysesMembrane FilterType of filtering media that is absorbentCotton FilterType of filtering media that is loosely inserted in the neck of the funnelCotton FilterDisadvantage of using cotton filter as filtering mediaRefiltration is necessaryType of filtering media resistant to chemical action, thus, are used for highly reactive chemicals (ie: strong acids)Glass Wool FilterType of filtering media that is flat or convex plate with Jena powdered glass that are molded togetherSintered Glass FilterType of filtering media where vacuum attachment is requiredSintered Glass FilterType of filtering media used to filter parenteral solutionsSintered Glass FilterIncreases the efficiency of the filtration processAdsorbentAdsorbents used must be what?Soluble InertAdsorbents used in filtrationPurified Talc Kieselguhr or Pure Silica Siliceous Earth or Clay Charcoal Chalk, magnesium carbonateAdsorbent used in filtration that is not the palpable kindPurified TalcIncapable of being felt by touch; so finely divided that no grains or grit can be feltImpalpableAdsorbent for general filtration processesKieselguhr or pure silicaAdsorbent that is inert and adsorbs liquidKieselguhr or pure silicaFuller's earth or kaolin in hydrated formSiliceous earth or clayAdsorbent used to filter fixed oils but should not be used for liquid with coloring matter or alkaloidal principlesSiliceous earth or clayAdsorbs color, odor, alkaloids, and glycosidesCharcoalAdsorbent which readily react with acids and possess a finite solubility in water with a production of an alkaline aqueous solution which can precipitate alkaloidsChalk, magnesium carbonateAids in the filtration process; can use pump-acting process by water pressure where no leaks should be present in the connectionsVacuum filtrationVacuum filter connected to a pump which pulls water from solution to be filteredBuchner filterExamples used in vacuum filtrationBuchner filter Gooch crucible (perforated) FlaskType of filtering media that is folded or flutedFilter PaperThe process by which finely divided solids and colloidal materials are separated from liquids without the use of filtersClarificationThis is employed when the contaminating material is finely subdivided, amorphous, or colloidal in natureClarificationThis tends to plug a filtration medium rapidlyClarification2 Methods of ClarificationGravitational sedimentation Use of a clarifying agentThe simplest method of clarification; least amount of labor and expenseGravitational sedimentationThis is the sediment formed in gravitational sedimentation which separates due to gravity from a liquidSludgeExamples are fixed oils and vegetable oil (Method of clarification)Gravitational sedimentationMethod of clarification that is added, shaken and removed by filtrationUse of a clarifying agentMethod of clarification that acts to reduce turbidity by physical adsorptionUse of a clarifying agentClarifying agents usedPaper Talc albumin Gelatin PolyaminesA process of depriving solutions of color by use of an adsorptive mediumDecolorizationExamples of DecolorationAnimal charcoal/bone black Wood charcoal Activated charcoal Bentonite Kaolin Fuller's earthSimplest method for the separation of a solid from its soluble impuritiesDecantationInvolves washing and subsequent agitation of the solid with an appropriate solvent, allowing the solid to settle then removing the supernatant liquidDecantationRepeated to attain the degree of desired purity of the solidDecantationConveniently done with a lipped vessel that is not filled to capacityDecantationThis is used in decantation as a guide to steady the hand of the operatorStirring rodStrainingColationIt separates the solid from the liquid by pouring the mixture on a cloth or porous material that will permit the fluid to pass through but will retain the solidColationIt is filtration using larger pores in the straining medium/cloth (flannel, muslin, wool, cheesecloth) which is colorless and washed before useColationStraining medium/cloth used in ColationFlannel Muslin Wool CheeseclothHow do you wash the straining cloth before using in colation?Soak in distilled water for a few hours, rinsed, boiled in distilled water then rinsed wellForcibly separating liquids from solidsExpressionBest method for expression; uses a clothSpiral Twist PressMethod for expression used for large scale pressing of oily seeds, fatty substances; uses rubberRoller PressMethod for expression wherein care must be taken to apply the force gradually and not to use it on corrosive materialsRoller PressMethod of expression that is expensive but most economical in terms of the increased power obtained with the least laborHydrostatic or Hydraulic PressThe principle of this method of expression is based on the fact that pressure exerted upon an enclosed liquid is transmitted equally in all directionsHydrostatic or Hydraulic PressMethods of ExpressionSpiral twist press Roller press Hydrostatic or Hydraulic press3 steps in precipitation and crystallizationSupersaturation Formation of nuclei Growth of crystalsEvaporate solvent → cool → formation of crystalsSupersaturationStep in precipitation and crystallization which is thought to consist of 10 to a few hundred molecules having the spatial arrangement of the crystals that will be grown ultimately from themFormation of nucleiSuspension → Ostwald ripening (formation of hard cake)Growth of crystalsHow does the nature of crystals obtained be controlled or modified?Existence of polymorphs The habit or shape of the crystal formModification of crystals where careful temperature control and seeding with desired crystal form is necessaryExistence of polymorphsModification of crystals that depends highly on impurities in the solution, pH, rate of stirring, rate of cooling, and the solvent.The habit or shape of the crystal formPutting together of ingredients in one mass or assemblage with more or less thorough dispersion of the constituted elements among one anotherMixingIts objective is to obtain dosage units which contains the same quantity of drug substanceMixingMechanism of fluid mixing that involves the movement of a relatively large portion of the fluid being mixed from one location in the system to anotherBulk transportMechanism of fluid mixing that makes use of paddles, revolving blades or other mechanisms or shuffling which move adjacent volumes of the fluid in three dimensional directionsBulk transportMechanism of fluid mixing that must result in a rearrangement or permutation of the various portions of the fluid being mixed to be considered effectiveBulk transportMoving in an irregular or violent wayTurbulentDirect result of turbulent fluid flow which is the random fluctuations of fluid velocity at any given point within the systemTurbulent MixingMechanism of fluid mixing based on streamline or laminar flowLaminar MixingMechanism of fluid mixing encountered in processing highly viscous liquids, but also in stirring that is gentle and adjacent to stationary surfaces in a vesselLaminar MixingMechanism of fluid mixing that is achieved by mixers which stretches and sometimes even folds the fluid being mixed (the mixing produces a folding effect as the layers of the fluid are stretched)Laminar MixingMechanism of fluid mixing that involves diffusion which results from thermal motion of the molecules (involves heat to cause vibration of molecules)Molecular DiffusionWhy is heat involved in molecular diffusion?To cause vibration of moleculesMechanism of fluid mixing usually performed with laminar mixing to reduce sharp discontinuities at the interfaces between the fluid layersMolecular DiffusionUsed when material to be mixed is limited in volume and can be conveniently contained in a suitable mixerBatch MixingTwo primary components of batch mixingA tank or other container suitable to hold the material being mixed A means of supplying energy to the system so as to bring about reasonably rapid mixingImpellersPropellers and turbinesImpellers that produce radial flowPropellerImpellers that produce axial and tangential flowTurbineImpellers that are most efficient when they can run at high speed in liquids of relatively low viscosityPropellerEquipment used in batch mixing usually arranged in a way that allows the buoyancy of the bubbles to lift the liquid from the bottom to the top of the mixing vesselAir jetsEquipment used in batch mixing that is used in liquids of low viscosity, non-foaming, unreactive with the gas employed and non-volatileAir jetsMechanisms of fluid mixingBulk transport Turbulent mixing Laminar mixing Molecular diffusionBatch mixing equipment used in fluid mixingImpellers Air jets Fluid jetsEquipment used in batch fluid mixing wherein fluids are pumped through nozzles arranged to permit good circulation of material throughout the tankFluid jetsEquipment used in batch fluid mixing that generate turbulent flow in the direction of their axes (like propellers); does not generate tangential flowFluid jetsWhy is molecular diffusion usually performed with laminar mixingTo reduce sharp discontinuities at the interfaces between the fluid layersThis produces an uninterrupted supply of freshly mixed material; desirable in handling very large volumes of materialContinuous MixingContinuous Mixing is accomplished through the use ofA tube or pipe In a chamberContinuous mixing is achieved through little back flow or recirculationA tube or pipeContinuous mixing is accomplished where in which a considerable amount of holdup and recirculation occurIn a chamberThe feed rate within the tube is carefully controlled and should be uniform via an exact metering deviceContinuous MixingIf the rate is difficult to control in continuous mixing, this type is usedTank typeComplex arrays of interconnected tanks (series or parallel) can be used for mixingContinuous mixingFactors to consider in mixer selectionPhysical properties Economic considerations Cost of equipment and its maintenanceFactors to consider in physical properties of the materials to be mixedDensity Viscosity MiscibilityEconomic considerations regarding processingTime required for mixing The powder expenditure necessaryBest mixed by method that generate a high degree of turbulence and circulate the entire mass of materialLow ViscosityMixed by air jets, fluid jets, and high-speed impellersLow ViscosityMixed by turbines of flat blade design (relative insensitivity of their power consumption to density or viscosity)High ViscosityComposed of several liquid or solid phasesPolyphase SystemsInvolves the subdivision or deaggregation of one or more of the phases present with subsequent dispersal throughout the mass of material to be mixedPolyphase SystemsMay involve homogenization, suspension formation, and emulsificationPolyphase SystemsMixing requires the subdivision of one of the phases into globules which are successively reduced in size and are then distributed throughout the bulk of the liquidImmiscible LiquidsExample of low viscosity immiscible liquidsEmulsionsRequires high shear rates produced by passing the fluid under high pressure through small orifices or by bringing it into contact with rapidly moving surfacesLow ViscosityExample of high viscosity immiscible liquidOintmentDispersed by the shearing action of two surface in close proximity and moving at different velocities with respect to each otherHigh ViscosityAchieved in paddle mixers (in which the blades clear the container wall by small tolerance)High ViscosityWhy is high viscosity immiscible liquids relatively efficient?Generate sufficient shear to reduce globule size Induce sufficient circulation of material to ensure a uniform dispersion throughout the completed mixtureMixing depends on separation of aggregates into primary particles and the distribution of these particles throughout the fluidFinely-divided Solids in LiquidsMixing is done with the help of equipment like high speed turbines which generate shear forces of sufficient intensity to disrupt aggregatesFinely-divided Solids in LiquidsEfficient in deaggregation of solids but are typically inefficient in distributing the articles uniformly through the entire massMuller MixersComposed of abrasion-resistant rollers arranged to come into close proximity to each other which are rotated at different rates of speedRoller MixersMaterials coming in between the rollers are crushed, depending on the gap, and are also sheared by the difference in rates of movement of the two surfacesRoller MixersMixers used in batch mixingTumbling mixers Stationary mixersConsists of a container of one of several geometric forms which is mounted so that it can be rotated about an axisTumbling MixersThe resulting tumbling motion is accentuated by means of baffles or simply by virtue of the shape of the containerTumbling MixersEfficiency of tumbling mixers is highly dependent on what?Speed of rotationWhat happens when the rotation that is too slow in tumbling mixers?Does not produce the desired intense tumbling or cascading motion, nor does it generate rapid shear ratesWhat happens when the rotation is too rapid in tumbling mixers?Tends to produce centrifugal force sufficient to hold the powder to the sides of the mixer and thereby reduce efficiencyOptimum rate of rotation depends on what?Size and shape of tumblerCommon range of optimum rate in tumbling mixer30-100 rpmA device used to restrain the flow of a fluid, gas, or loose material or to prevent the spreading of sound or light in a particular directionBaffleTakes the form of a cylinder that has been cut in half approximately a 45-degree angle with its long axis and then rejoined to form a "V" shapeTwin-shell BlenderAs the blender tumbles, the material randomly mixes which causes the final blend to be very homogenousTwin-shell BlenderStationary MixersRibbon blender Helical flight mixerConsists of a stationary container to hold the material and moving crews, paddles or blades to bring about mixingStationary MixerDoes not depend entirely on gravity; useful in mixing solids that have been wetted (sticky or plastic state)Stationary MixerConsists of a horizontal cylindric tank usually opening at the top and fitted with helical bladesRibbon BlenderBlades are mounted on a shaft through the long axis of the tank and are often of both right -and-left-hand twistRibbon BlenderPowders are lifted by a centrally located vertical screw and allowed to cascade to the bottom of the tankHelical Flight MixerAll else being equal, mixtures produced by large mixers have greater variations in composition than those produced by small mixersContinuous MixingAn important consideration in continuous mixingContent uniformityMetered quantities of the powders or granules are passed through a device that reduces both the scale and intensity of segregation, usually by impact or a shearing actionContinuous MixingOutput may be transferred directly to capsule filling or tablet machines.Continuous Mixing

MANUF LEC: Commercial Manufacturing Part 1

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