C	C176677	PQ/CMC Units of Measure Terminology	C92953	Allergen Unit for Ambrosia artemisiifolia	An arbitrary unit for the measurement of Amb a 1 (or Antigen E), a 38 kD glycoprotein that is the major allergen in short ragweed pollen allergen extracts.	[Amb'a'1'U]	Amb a 1 units	
A	C217408	PQ/CMC Unit Operations Category Terminology	C112925	Granulation	The act of forming something into grains.	Granulation		The process of creating granules. The powder morphology is modified through the use of either a liquid that causes particles to bind through capillary forces or dry compaction forces. The process will result in one or more of the following powder properties: enhanced flow; increased compressibility; densification; alteration of physical appearance to more spherical, uniform, or larger particles; and/or enhanced hydrophilic surface properties.
A	C217408	PQ/CMC Unit Operations Category Terminology	C112926	Particle Sizing	Separation of particles into size-differentiated fractions.	Particle Separation		Particle size classification according to particle size alone.
A	C217408	PQ/CMC Unit Operations Category Terminology	C16583	Filtration	The process of passing a liquid or gas through a filter.	Filtration		The process of passing a substance through a porous material to remove impurities and solid particles.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217576	Dosage Form Printing	The marking of a capsule or tablet surface for the purpose of product identification. Printing may be accomplished by either the application of a contrasting colored polymer (ink) onto the surface of a capsule or tablet, or by the use of laser etching.	Printing		The marking of a capsule or tablet surface for the purpose of product identification. Printing may be accomplished by either the application of a contrasting colored polymer (ink) onto the surface of a capsule or tablet, or by the use of laser etching.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217578	Dosage Form Coating	The uniform deposition of a layer of material on or around a solid dosage form, or component thereof.	Coating		The uniform deposition of a layer of material on or around a solid dosage form, or component thereof.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217599	Coat/Film Laser Drilling	The drilling or ablating of a hole or holes through the polymeric film coating shell on the surfaces of a solid oral dosage form using a laser. The polymeric film shell is not soluble in vivo. The hole or holes allow for the modified release of the drug from the core of the dosage form.	Drilling		The drilling or ablating of a hole or holes through the polymeric film coating shell on the surfaces of a solid oral dosage form using a laser. The polymeric film shell is not soluble in vivo. The hole or holes allow for the modified release of the drug from the core of the dosage form.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217613	Drying by Evaporation	The process of removing liquid from a substance by evaporation.	Drying		The removal of a liquid from a solid by evaporation.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217615	Filling Non-Sterile Primary Packaging	The delivery of target weight or volume of bulk finished product to primary pack containers.	Packaging (non-sterile products)/Filling		The delivery of target weight or volume of bulk finished product to primary pack containers.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217619	Homogenization by Blending and Mixing	The reorientation of particles relative to one another to achieve uniformity.	Blending and Mixing		The reorientation of particles relative to one another to achieve uniformity.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217624	Medical Product Filling or Aseptic Processing	A method of preparing pharmaceutical and medical products that involves the separate sterilization of the product and of the package, the transfer of the product into the container, and closure of the container under at least ISO Class 5 conditions and using procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.	Filling or Aseptic Processing		A method of preparing pharmaceutical and medical products that involves the separate sterilization of the product and of the package, the transfer of the product into the container, and closure of the container under at least ISO Class 5 conditions and using procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217626	Pharmaceutical Powder Portioning	The division of a pharmaceutical powder blend into uniform smaller portions.	Unit Dosing		The division of a powder blend into uniform single portions for delivery to patients.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217632	Sealing Non-Sterile Primary Packaging	A device or process for closing and/or sealing primary pack containers following the filling process.	Packaging (non-sterile products)/Sealing		A device or process for closing and/or sealing primary pack containers following the filling process.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217633	Soft Gel Drying	The removal of the majority of water from the capsule's gel shell by tumbling and subsequent tray drying using conditioned air, which enhances the size, shape, and shell physical properties of the final product. The drying operation is unique to each manufacturer's operation and generally uses in-house fabricated equipment.	Soft Gel, Drying		The removal of the majority of water from the capsule's gel shell by tumbling and subsequent tray drying using conditioned air, which enhances the size, shape, and shell physical properties of the final product. The drying operation is unique to each manufacturer's operation and generally uses in-house fabricated equipment.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217634	Soft Gel Encapsulation	The continuous casting of gel ribbons, with liquid fill material being injected between the gel ribbons using a positive displacement pump or, for dry materials being gravity or force fed with capsule formation using a rotary die.	Soft Gel, Encapsulation		The continuous casting of gel ribbons, with liquid fill material being injected between the gel ribbons using a positive displacement pump or, for dry materials being gravity or force fed with capsule formation using a rotary die.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217635	Soft Gel Fill Mixing	The mixing of either liquids or solids with other liquids to form a solution; blending of limited solubility solid(s) with a liquid carrier and suspending agents used to stabilize the blend to form a suspension; or the uniform combination of dry inert and drug active substances to form a dry powder fill suitable for encapsulation.	Soft Gel, Fill Mixing		The mixing of either liquids or solids with other liquids to form a solution; blending of limited solubility solid(s) with a liquid carrier and suspending agents used to stabilize the blend to form a suspension; or the uniform combination of dry inert and drug active substances to form a dry powder fill suitable for encapsulation.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217636	Soft Gel Inspection/Sorting	The process wherein undesirable capsules are removed, including misshapen, leaking, and unfilled capsules as well as agglomerates of capsules.	Soft Gel, Inspection/Sorting		The process wherein undesirable capsules are removed, including misshapen, leaking, and unfilled capsules as well as agglomerates of capsules.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217637	Soft Gel Mass Preparation	The manufacture of a homogeneous, degassed liquid mass of gelatin, plasticizer, water, and other additives, either in solution or suspension, such as colorants, pigments, flavors, preservatives, that comprise a functional gel shell formation.	Soft Gel, Mass Preparation		The manufacture of a homogeneous, degassed liquid mass (solution) of gelatin, plasticizer, water, and other additives, either in solution or suspension, such as colorants, pigments, flavors, preservatives, etc., that comprise a unique functional gel shell formation. The operation may be performed in discreet steps or by continuous processing. Minor components can be added after the liquid gel mass is made.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217638	Soft Gel Washing	The continuous removal of a lubricant material from the outside of the formed capsule. The washing operation is unique to each manufacturer's operation and generally uses in-house fabricated equipment.	Soft Gel, Washing		The continuous removal of a lubricant material from the outside of the formed capsule. The washing operation is unique to each manufacturer's operation and generally uses in-house fabricated equipment.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217639	Temperature Conditioning	The process of treating air to control its temperature to meet the specified requirements.	Temperature Conditioning		The process of treating air to control its temperature to meet the requirement of conditioned space.
A	C217408	PQ/CMC Unit Operations Category Terminology	C217640	Transferring Non-Sterile Medical Product Packaging	The process of relocating bulk finished product from holding to filling equipment using pipe, hose, pumps and/or other associated components.	Packaging (non-sterile products)/Transfer		The process of relocating bulk finished product from holding to filling equipment using pipe, hose, pumps and/or other associated components.
A	C217408	PQ/CMC Unit Operations Category Terminology	C84382	Sterilization	A process for killing microorganisms.	Sterilization		Validated process used to render product free from viable microorganisms. See ISO/TS 11139.
A	C217408	PQ/CMC Unit Operations Category Terminology	C84386	Particle Size Reduction	The mechanical process of breaking particles into smaller pieces via one or more particle size reduction mechanisms. Milling is the most common process used.	Particle Size Reduction		The mechanical process of breaking particles into smaller pieces via one or more particle size reduction mechanisms. The mechanical process used generally is referred to as milling.
A	C217408	PQ/CMC Unit Operations Category Terminology	C84732	Labeling Activity	The action of affixing an identifier to an item or the container for an item.	Labelling		The action of affixing an identifier to an item or the container for an item.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C106177	Micronization	A process to reduce a solid material to particles with an average size described in microns.	Fluid Energy Milling		Particles are reduced in size as a result of high-speed particle-to-particle impact and/or attrition; also known as micronizing.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C112973	Laser Drill Formulation Process	A process that uses a laser to drill holes in a tablet.	Laser Drilling		A drilling system typically is a custom built unit consisting of a material handling system to orient and hold the solid dosage form, a laser (or lasers), and optics (lenses, mirrors, deflectors, etc.) to ablate the hole or holes, and controls. The drilling unit may include debris extraction and inspection systems as well. The sorting, orienting, and holding equipment commonly is provided by dosage form printing equipment manufacturers, and is considered ancillary in this use.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C112976	Rotating Pan Coating Method	A method that agitates a substrate in a rotating pan while it is sprayed with a layer of coating material.	Pan Coating		The uniform deposition of coating material onto the surface of a solid dosage form, or component thereof, while being translated via a rotating vessel.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C112979	Flash Drying Method	A process that removes water or volatile solvents from a bed of solids by relying on absorption of heat radiation by those solvents.	Direct Heating, Dilute Solids Bed, Flash Drying		Heat transfer is accomplished by direct contact between wet solids and hot gases. The solid mass is suspended in a finely divided state in a high-velocity and high-temperature gas stream. The vaporized liquid is carried away by the drying gases.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C112980	Fluid Bed Drying Method	A process that removes water or volatile solvents using large volumes of hot air to suspend a bed of solids.	Direct Heating, Fluidized Solids Bed		Heat transfer is accomplished by direct contact between the wet solids and hot gases. The vaporized liquid is carried away by the drying gases. The solids are in an expanded condition, with the particles supported by drag forces caused by the gas phase. The solids and gases intermix and behave like a boiling liquid. This process commonly is referred to as fluid bed drying.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113005	Dry Roller Compaction Granulation	The act of forming granules by mechanically applying pressure by rollers to form a compact that is subsequently milled and screened resulting in dry granules.	Dry Granulation		Dry powder densification and/or agglomeration by direct physical compaction.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113007	Extrusion Granulation	The use of a series of integrated steps whereby a dry powder is conditioned to form a plasticized mass that is forced through a screen and cut into sections, ultimately to yield granules possessing characteristic dimensions and density.	Extrusion Granulation		Plasticization of solids or wetted mass of solids and granulation fluid with linear shear through a sized orifice using a pressure gradient.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113008	Fluid Bed Granulation	The process of forming granules involving the addition of liquid to bind particles as they are suspended in a fluidized state by a flowing gas stream, resulting in dry granules suitable for filling or compression.	Fluid Bed Granulation		Powder densification and/or agglomeration with little or no shear by direct granulation fluid atomization and impingement on solids, while suspended by a controlled gas stream, with simultaneous drying.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113009	Fluidized Hot Melt Granulation	The process of forming granules using meltable binders to agglomerate dry powders under elevated temperatures resulting in granules suitable for filling or compression.	Hot-melt Granulation		An agglomeration process that utilizes a molten liquid as a binder(s) or granulation matrix in which the active pharmaceutical ingredient (API) is mixed and then cooled down followed by milling into powder. This is usually accomplished in a temperature controlled jacketed high shear granulating tank or using a heated nozzle that sprays the molten binders(s) onto the fluidizing bed of the API and other inactive ingredients.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113011	High Shear Granulation	The use of a series of integrated steps whereby a dry powder is conditioned by wetting, or is melted, to form a plasticized mass that with the aid of high shear forces yields relatively dense particles.	Wet High-Shear Granulation		Powder densification and/or agglomeration by the incorporation of a granulation fluid into the powder with high-power-per-unit mass, through rotating high-shear forces.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113012	Low Shear Granulation	The use of a series of integrated steps whereby a dry powder is conditioned by wetting or is melted to form a plasticized mass that with the aid of low shear forces, yields particles possessing characteristic dimensions and density.	Low-Shear Tumble Granulation		Powder densification and/or agglomeration by the incorporation of a granulation fluid into the powder with low-power-per-unit mass, through rotation of the container vessel and/or intensifier bar.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113013	Spray Granulation	Granulation involving the atomization of a slurry of fine particles that are bound as they are suspended and conveyed by a flowing hot gas stream, resulting in dry granules suitable for filling or compression.	Spray Dry Granulation		A pumpable granulating liquid containing solids (in solution or suspension) is atomized in a drying chamber and rapidly dried by a controlled gas stream, producing a dry powder.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113025	Dry Powder Convection Mixing	Mixing of dry ingredients by mechanical agitation within a containment zone.	Convection Mixing		Particles are reoriented in relation to one another as a result of mechanical movement; also known as paddle or plow mixing.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113027	Dry Powder Pneumatic Mixing	Mixing of dry ingredients by dispersion and turbulence within a flowing stream of gas.	Pneumatic Mixing		Particles are reoriented in relation to one another as a result of the expansion of a powder bed by gas.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113040	Screening Particle Sizing	Separation of dry particles into size-differentiated fractions by mechanical movement through fixed mesh screens.	Separating		Particles are segregated based upon particle size alone and without any significant particle size reduction. This process commonly is referred to as screening or bolting.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113042	Wet Milling Particle Sizing	A process to reduce the particle size of a slurry material by attrition using either grinding or mechanical shear.	Wet Low-Shear Granulation		Powder densification and/or agglomeration by the incorporation of a granulation fluid into the powder with low-power-per-unit mass, through rotating low-shear forces.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C113071	Terminal Sterilization	Sterilization of a finished product.	Terminal Sterilization		Sterilization following production using steam, gas, dry heat, water, or radiation.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C16475	Cryopreservation	Preservation of cells, tissues, organs, or embryos by storage at low temperatures.	Cryopreservation		Storage at very low temperature, usually in liquid nitrogen or the vapor phase of liquid nitrogen.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C214703	Visual Inspection	Human evaluation of an attribute of a subject or material using visual discernment.	Visual Inspection		The assessment and physical removal of misshapen or leaking packages using a manual operation.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217577	Primary Package Filling	Filling operating principles involve several associated subprinciples. The primary package can be precleaned to remove particulates or other materials by the use of ionized air, vacuum, or inversion. A holding vessel equipped with an auger, gravity, or pressure material feeding system should be used. The vessel may or may not be able to control temperature and/or agitation. Actual filling of the dosage form into primary containers can involve a metering system based on an auger, gear, orifice, peristaltic, or piston pump. A head-space blanketing system can also be used.	Filling		Filling operating principles involve several associated subprinciples. The primary package can be precleaned to remove particulates or other materials by the use of ionized air, vacuum, or inversion. A holding vessel equipped with an auger, gravity, or pressure material feeding system should be used. The vessel may or may not be able to control temperature and/or agitation. Actual filling of the dosage form into primary containers can involve a metering system based on an auger, gear, orifice, peristaltic, or piston pump. A head-space blanketing system can also be used.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217596	Active Pharmaceutical Ingredient Melt Extrusion	A process that involves melting and mixing API and an excipient (generally a polymer) using low or high shear kneading screws followed by cooling and then milling into granules. Thermal energy for melting is usually supplied by the electric/water heater placed on the barrel. Materials are either premixed or fed into an extruder separately. Melt extruder subclasses primarily are distinguished by the configuration of the screw.	Melt Extrusion		A process that involves melting and mixing API and an excipient (generally a polymer) using low or high shear kneading screws followed by cooling and then milling into granules. Thermal energy for melting is usually supplied by the electric/water heater placed on the barrel. Materials are either premixed or fed into an extruder separately. Melt extruder subclasses primarily are distinguished by the configuration of the screw.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217597	Aseptic Filtration	The use of a porous filter to remove microorganisms from liquids or gases.	Aseptic Sterilization (Filtration)		The process of passing a substance through a porous material to remove living organisms.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217598	Capsule Inspection/Sorting	The physical removal of misshapen, leaking, or agglomerated capsules, using either a manual or automatic operation.	Inspection/Sorting		The physical removal of misshapen, leaking, or agglomerated capsules, using either a manual or automatic operation.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217600	Compression Dosage Form Coating	A coating process where a dry coatings blend is applied on a previously compressed core tablet using a tablet compression machine. Therefore, this process is also known as a dry coating process that does not involve any water or any other solvent in the coating process.	Compression Coating		A coating process where a dry coatings blend is applied on a previously compressed core tablet using a tablet compression machine. Therefore, this process is also known as a dry coating process that does not involve any water or any other solvent in the coating process.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217601	Compression Milling	Particles are reduced in size by compression stress and shear between two surfaces.	Compression Milling		Particles are reduced in size by compression stress and shear between two surfaces.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217602	Cutting	Particles are reduced in size by mechanical shearing.	Cutting		Particles are reduced in size by mechanical shearing.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217603	Deaeration	The removal of entrapped air from either the gel mass or fill material, solution, or suspension. This process can take place in either the mixing vessel, through the application of vacuum, or a separate off-line step.	Deaeration		The removal of entrapped air from either the gel mass or fill material, solution, or suspension. This process can take place in either the mixing vessel, through the application of vacuum, or a separate off-line step.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217604	Deaggregation	The removal of aggregates using a suitable homogenizer/mill to provide a pumpable fill material.	Deaggregation		The removal of aggregates using a suitable homogenizer/mill to provide a pumpable fill material. The procedure has minimal effect on the particle size distribution of the initial solid component(s), and is viewed as a processing aid. (Carstensen, J. T., Theory of Pharmaceutical Systems, Volume 11 Heterogeneous Systems, Academic Press, New York, NY, 1973, p 51.)
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217605	Diffusion Blending	Particles are reoriented in relation to one another when they are placed in random motion and interparticular friction is reduced as the result of bed expansion (usually within a rotating container).	Diffusion Blending (Tumble)		Particles are reoriented in relation to one another when they are placed in random motion and interparticular friction is reduced as the result of bed expansion (usually within a rotating container); also known as tumble blending.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217606	Dip Dosage Form Coating	Coating is applied to the substrate by dipping it into the coating material. Drying is accomplished using pan coating equipment.	Dip Coating		Coating is applied to the substrate by dipping it into the coating material. Drying is accomplished using pan coating equipment.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217607	Direct Heat Drying, Moving Solids Bed	Heat transfer is accomplished by direct contact between the wet solids and hot gases. The vaporized liquid is carried away by the drying gases. Solids motion is achieved by either mechanical agitation or gravity force, which slightly expands the bed enough to flow one particle over another.	Direct Heating, Moving Solids Bed		Heat transfer is accomplished by direct contact between the wet solids and hot gases. The vaporized liquid is carried away by the drying gases. Solids motion is achieved by either mechanical agitation or gravity force, which slightly expands the bed enough to flow one particle over another.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217608	Direct Heat Drying, Static Solids Bed	Heat transfer is accomplished by direct contact between the wet solids and hot gases. The vaporized liquid is carried away by the drying gases. There is no relative motion among solid particles. The solids bed exists as a dense bed, with the particles resting upon one another.	Direct Heating, Static Solids Bed		Heat transfer is accomplished by direct contact between the wet solids and hot gases. The vaporized liquid is carried away by the drying gases. There is no relative motion among solid particles. The solids bed exists as a dense bed, with the particles resting upon one another.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217609	Direct Heating, Dilute Solids Bed, Spray Drying	Heat transfer is accomplished by direct contact between a highly dispersed liquid and hot gases. The feed liquid may be a solution, slurry, emulsion, gel or paste, provided it is pumpable and capable of being atomized. The fluid is dispersed as fine droplets into a moving stream of hot gases, where they evaporate rapidly before reaching the wall of the drying chamber. The vaporized liquid is carried away by the drying gases. The solids are fully expanded and so widely separated that they exert essentially no influence on one another.	Direct Heating, Dilute Solids Bed, Spray Drying		Heat transfer is accomplished by direct contact between a highly dispersed liquid and hot gases. The feed liquid may be a solution, slurry, emulsion, gel or paste, provided it is pumpable and capable of being atomized. The fluid is dispersed as fine droplets into a moving stream of hot gases, where they evaporate rapidly before reaching the wall of the drying chamber. The vaporized liquid is carried away by the drying gases. The solids are fully expanded and so widely separated that they exert essentially no influence on one another.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217610	Dosage Form Ink-Based Printing	The application of contrasting colored polymer (ink) onto the surface of a tablet or capsule.	Ink-Based Printing		The application of contrasting colored polymer (ink) onto the surface of a tablet or capsule.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217611	Dosage Form Laser Etching	The application of identifying markings onto the surface of a tablet or capsule using laser-based technology.	Laser Etching		The application of identifying markings onto the surface of a tablet or capsule using laser-based technology.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217612	Dose Tabletting	The division of a powder blend in which compression force is applied to form a single unit dose.	Tabletting		The division of a powder blend in which compression force is applied to form a single unit dose. (note: embossing is covered here)
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217614	Electrostatic Dosage Form Coating	A strong electrostatic charge is applied to the surface of the substrate. The coating material containing oppositely charged ionic species is sprayed onto the substrate.	Electrostatic Coating		A strong electrostatic charge is applied to the surface of the substrate. The coating material containing oppositely charged ionic species is sprayed onto the substrate.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217616	Gas Stripping	The use of an inert gas to remove a dissolved gas from a substance.	Gas Stripping		Heat transfer is a combination of direct and indirect heating. The solids motion is achieved by agitation and the bed is partially fluidized.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217617	Gas Suspension Dosage Form Coating	The application of a coating material onto a solid dosage form, or component thereof, while being entrained in a process gas stream. Alternatively, this may be accomplished simultaneously by spraying the coating material and substrate into a process gas stream.	Gas Suspension		The application of a coating material onto a solid dosage form, or component thereof, while being entrained in a process gas stream. Alternatively, this may be accomplished simultaneously by spraying the coating material and substrate into a process gas stream.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217618	Hard Gelatin Encapsulating	The division of material into a hard gelatin capsule. Encapsulators should all have the following operating principles in common: rectification (orientation of the hard gelatin capsules), separation of capsule caps from bodies, dosing of fill material/formulation, rejoining of caps and bodies, and ejection of filled capsules.	Encapsulating		The division of material into a hard gelatin capsule. Encapsulators should all have the following operating principles in common: rectification (orientation of the hard gelatin capsules), separation of capsule caps from bodies, dosing of fill material/formulation, rejoining of caps and bodies, and ejection of filled capsules.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217620	Impact Milling	Particles are reduced in size by high-speed mechanical impact or impact with other particles; also known as milling, pulverizing, or comminuting.	Impact Milling		Particles are reduced in size by high-speed mechanical impact or impact with other particles; also known as milling, pulverizing, or comminuting.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217621	Indirect Conduction Drying, Moving Solids Bed	Heat transfer to the wet solid is through a retaining wall. The vaporized liquid is removed independently from the heating medium. Solids motion is achieved by either mechanical agitation or gravity force, which slightly expands the bed enough to flow one particle over another.	Indirect Conduction, Moving Solids Bed		Heat transfer to the wet solid is through a retaining wall. The vaporized liquid is removed independently from the heating medium. Solids motion is achieved by either mechanical agitation or gravity force, which slightly expands the bed enough to flow one particle over another.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217622	Indirect Conduction Drying, Static Solids Bed	Heat transfer to the wet solid is through a retaining wall. The vaporized liquid is removed independently from the heating medium. There is no relative motion among solid particles. The solids bed exists as a dense bed, with the particles resting upon one another.	Indirect Conduction, Static Solids Bed		Heat transfer to the wet solid is through a retaining wall. The vaporized liquid is removed independently from the heating medium. There is no relative motion among solid particles. The solids bed exists as a dense bed, with the particles resting upon one another.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217623	Indirect Radiant Drying, Moving Solids Bed	Heat transfer is accomplished with varying wavelengths of energy. Vaporized liquid is removed independently from the solids bed. The solids motion is achieved by mechanical agitation, which slightly expands the bed enough to flow one particle over one another. This process commonly is referred to as microwave drying.	Indirect Radiant, Moving Solids Bed		Heat transfer is accomplished with varying wavelengths of energy. Vaporized liquid is removed independently from the solids bed. The solids motion is achieved by mechanical agitation, which slightly expands the bed enough to flow one particle over one another. This process commonly is referred to as microwave drying.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217625	Package Capping	The provision of a protective or obstructive covering on a container.	Capping		The provision of a protective or obstructive covering on a container.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217627	Powder Filling	The division of a powder blend into a container closure system.	Powder Filling		The division of a powder blend into a container closure system.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217628	Primary Package Sealing	Primary packages can be sealed using a variety of methods, including conducted heat and electromagnetic (induction or microwave) or mechanical manipulation (crimping or torquing).	Sealing		Primary packages can be sealed using a variety of methods, including conducted heat and electromagnetic (induction or microwave) or mechanical manipulation (crimping or torquing).
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217629	Rotary Die Encapsulation	The formation of capsules using a rotary die machine.	Encapsulation		The formation of capsules using a rotary die machine. (Lachman, L., H. A. Lieberman, and J. L. Kanig (Eds.), The Theory and Practice of Industrial Pharmacy, Chapter 3, p. 359 (Stanley, J. P.), Philadelphia Lea & Febiger, 1971; Tyle, P. (Ed.), Specialized Drug Delivery Systems, Manufacturing and Production Technology, Chapter 10, p. 409 (Wilkinson, P.K. and F.S. Hom), New York; M. Dekker, 1990; Porter, S., Remington's Pharmaceutical Sciences, Edition 18, Chapter 89, pp. 1662 - 1665, Easton, Penn.: Mack Publishing Co.)
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217630	Rotary Granulation	Spheronization, agglomeration, and/or densification of a wetted or non-wetted powder or extruded material. This is accomplished by centrifugal or rotational forces from a central rotating disk, rotating walls, or both. The process may include the incorporation and/or drying of a granulation fluid.	Rotary Granulation		Spheronization, agglomeration, and/or densification of a wetted or non-wetted powder or extruded material. This is accomplished by centrifugal or rotational forces from a central rotating disk, rotating walls, or both. The process may include the incorporation and/or drying of a granulation fluid.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217641	Tumble Milling	Particles are reduced in size by attrition utilizing grinding media.	Tumble Milling		Particles are reduced in size by attrition utilizing grinding media.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217642	Vacuum Film Dosage Form Coating	This technique uses a jacketed pan equipped with a baffle system. Tablets are placed into the sealed pan, an inert gas (i.e., nitrogen) is used to displace the air and then a vacuum is drawn.	Vacuum Film Coating		This technique uses a jacketed pan equipped with a baffle system. Tablets are placed into the sealed pan, an inert gas (i.e., nitrogen) is used to displace the air and then a vacuum is drawn.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C217646	Reduction by Screening	Particles are reduced in size by mechanically induced attrition through a screen. This process commonly is referred to as milling or deagglomeration.	Screening		Particles are reduced in size by mechanically induced attrition through a screen. This process commonly is referred to as milling or deagglomeration.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C28150	Freeze-Drying	A dehydration process typically used to preserve a perishable material. The specimen is frozen and then dehydrated at low temperature in a high vacuum.	Indirect Conduction, Lyophilization		Drying in which the water vapor sublimes from the product after freezing.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C48160	Freezing	The act or event which causes the transition from a liquid to solid matter phase when the temperature is lowered.	Freezing		The act or event which causes the transition from a liquid to solid matter phase when the temperature is lowered.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C48167	Transfer	The act of conveying or transporting from one place to another.	Transfer		The controlled movement or transfer of materials from one location to another.
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C52474	Assembly	The act of constructing something.	Assembly (PFS, MDI, etc.)		A process in which all parts, components, and fasteners as defined in and assembled according to the manufacturer's assembly and installation instructions (prefilled syringe, metered-dose inhaler, etc.).
A	C217410	PQ/CMC Unit Operations Subcategory Terminology	C64925	Mix	To bring or combine together or with something else; add as an additional element or part.	Mixing		The combination of solid and liquid components, including suspending aid(s) at either ambient or elevated temperatures to form a solution, suspension, or dry powder blend for the manufacture of gel mass or fill material. Mixing also includes the incorporation of minor components into the liquid gel mass.