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    Pharmaceutical Unit Operation (Solid Dosage)

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    Sangram Kendre
    The document summarizes examples of pharmaceutical unit operations, critical material attributes, process parameters, and quality attributes for solid dosage forms. Key unit operations discussed include blending/mixing, size reduction/comminution, wet granulation, and drying. For each operation, example critical material attributes of the input material and example critical process parameters that can impact quality attributes are listed. The quality attributes provided relate to properties such as blend/granule uniformity, particle size, moisture content, and drug substance polymorphism.

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    Pharmaceutical Unit Operation (Solid Dosage)

    Uploaded by

    Sangram Kendre
    56 views8 pages
    The document summarizes examples of pharmaceutical unit operations, critical material attributes, process parameters, and quality attributes for solid dosage forms. Key unit operations discussed include blending/mixing, size reduction/comminution, wet granulation, and drying. For each operation, example critical material attributes of the input material and example critical process parameters that can impact quality attributes are listed. The quality attributes provided relate to properties such as blend/granule uniformity, particle size, moisture content, and drug substance polymorphism.

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    The document summarizes examples of pharmaceutical unit operations, critical material attributes, process parameters, and quality attributes for solid dosage forms. Key unit operations discussed include blending/mixing, size reduction/comminution, wet granulation, and drying. For each operation, example critical material attributes of the input material and example critical process parameters that can impact quality attributes are listed. The quality attributes provided relate to properties such as blend/granule uniformity, particle size, moisture content, and drug substance polymorphism.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    56 views8 pages

    Pharmaceutical Unit Operation (Solid Dosage)

    Uploaded by

    Sangram Kendre
    The document summarizes examples of pharmaceutical unit operations, critical material attributes, process parameters, and quality attributes for solid dosage forms. Key unit operations discussed include blending/mixing, size reduction/comminution, wet granulation, and drying. For each operation, example critical material attributes of the input material and example critical process parameters that can impact quality attributes are listed. The quality attributes provided relate to properties such as blend/granule uniformity, particle size, moisture content, and drug substance polymorphism.

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    of 8

    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    Pharmaceutical Example input Critical Example Critical Process Parameters Example Critical Quality Attributes
    Unit Operation Material Attributes
    Blending/Mixing • Particle size • Type and geometry of mixer • Blend uniformity
    • Particle size distribution • Mixer load level • Potency
    • Fines/Oversize • Order of addition • particle size
    • Particle shape • Number of revolutions • Particle size distribution
    • Bulk/Tapped/True density • (time and speed) • Bulk/Tapped/True density
    • Cohesive/Adhesive • Agitating bar (on/off pattern) • Moisture content
    properties • Discharge method • Flow properties
    • Electrostatic properties • Holding time • Cohesive/Adhesive properties
    • Moisture content • Environment temperature and RH • Powder segregation
    • Electrostatic properties
    Size Reduction • Particle/Granule size Impact/Cutting/ Screening mills • Particle/Granule size
    /Comminution • Particle/Granule size • Mill type • Particle/Granule size distribution
    distribution • Speed • Particle/Granule shape
    • Fines • Blade configuration, type, orientation • Particle/Granule shape factor (e.g.
    • Particle/Granule shape • Screen size and type aspect ratio)
    • Bulk/Tapped/True density • Feeding rate • Particle/Granule density/Porosity
    • Adhesive properties • Bulk/Tapped/True density
    • Electrostatic properties Fluid energy mill • Flow properties
    • Hardness/Plasticity • Number of grinding nozzles • API polymorphic form
    • Viscoelasticity • Feed rate • API crystalline morphology
    • Brittleness • Nozzle pressure • Cohesive/Adhesive properties
    • Elasticity • Classifier • Electrostatic properties
    • Solid form/Polymorph • Hardness/Plasticity
    • Moisture content Granule/Ribbon milling • Viscoelasticity
    • Granule porosity/density • Mill type • Brittleness
    Ribbon milling • Speed • Elasticity
    • Ribbon dimensions • Blade configuration, type, orientation
    • Ribbon density • Screen size and type
    • Ribbon porosity/solid • Feeding rate
    fraction
    •

    1
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    Wet Granulation • Particle size distribution High/Low shear granulation • Endpoint measurement (e.g. power
    • Fines/Oversize • Type of granulator (High/low shear, top/ consumption, torque, etc.)
    • Particle shape bottom drive) • Blend uniformity
    • Bulk/Tapped/True density • Fill level • Potency
    • Cohesive/Adhesive • Pre-granulation mix time • Flow
    properties • Granulating liquid or solvent quantity • Moisture content
    • Electrostatic properties • Impeller speed, tip speed, configuration, • Particle size and distribution
    • Hardness/Plasticity location, power consumption/torque • Granule size and distribution
    • Viscoelasticity • Chopper speed, configuration, location, • Granule strength and uniformity
    • Brittleness power consumption • Bulk/Tapped/True density
    • Elasticity • Spray nozzle type and location • API polymorphic form
    • Solid form/polymorph • Method of binder excipient addition • cohesive/adhesive properties
    • Moisture content (dry/wet) • Electrostatic properties
    • Method of granulating liquid addition • Granule brittleness
    (spray or pump) • Granule elasticity
    • granulating liquid temperature • Solid form/polymorph
    • granulating liquid addition rate and time
    • Wet massing time (post-granulation mix
    time)
    • Bowl temperature(jacket temperature)
    • Product temperature
    • Post mixing time
    • Pump Type: Peristaltic, Gear type
    • Granulating liquid vessel (e.g.:
    pressurized, heated)

    Fluid bed granulation


    • Type of fluid bed
    • Inlet air distribution plate
    • Spray nozzle (tip size, type/quantity/
    pattern/configuration/position)
    • Filter type and orifice size
    • Fill level
    2
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    • Bottom screen size and type


    • Preheating temperature/time
    • Method of binder excipient addition
    (dry/wet)
    • Granulating liquid temperature
    • Granulating liquid quantity
    • Granulating liquid concentration/viscosity
    • Granulating liquid holding time
    • Granulating liquid delivery method
    • Granulating liquid spray rate
    • Inlet air, volume, temperature, dew point
    • Atomization air pressure
    • Product and filter pressure differentials
    • Product temperature
    • Exhaust air temperature, flow
    • Filter shaking interval and duration
    Drying • Particle size, distribution Fluidized Bed • Granule size and distribution
    • Fines/Oversize • Inlet air volume, temperature, dew point • Granule strength, uniformity
    • Particle shape • Product temperature • Flow
    • Cohesive/Adhesive • Exhaust air temperature, flow • Bulk/Tapped/True density
    properties • Filter type and orifice size • Moisture content
    • Electrostatic properties • Shaking interval and duration • Residual solvents
    • Hardness/Plasticity • Total drying time • API polymorphic form or transition
    • Viscoelasticity • Purity profile
    • Brittleness Tray • Moisture profile (e.g. product
    • Elasticity • Type of tray dryer temperature vs. LOD)
    • Solid form/polymorph • Bed thickness/tray depth (depth of • Potency
    • Moisture content product per tray) • Cohesive/Adhesive properties
    • Type of drying tray liner (e.g. paper, • Electrostatic properties
    plastic, synthetic fiber, etc.)
    • Quantity carts and trays per chamber
    • Quantity of product per tray
    3
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    • Drying time and temperature


    • Air flow
    • Inlet dew point

    Vacuum/Microwave
    • Jacket temperature
    • Condenser temperature
    • Impeller speed
    • Bleed air volume
    • Vacuum pressure
    • Microwave power
    • Electric field
    • Energy supplied
    • Product temperature
    • Bowl and lid temperature
    • Total drying time
    • Particle size, distribution • Type of roller compactor • Ribbon appearance (edge attrition,
    Roller • Fines/Oversize • Auger (feed screw) type/design splitting, lamination, color, etc.)
    compaction • Particle shape (horizontal, vertical or angular) • Ribbon thickness
    /Chilsonation • Cohesive/Adhesive • Deaeration (e.g. vacuum) • Ribbon density (e.g. envelop
    properties • Auger (feed screw) speed density)
    • Electrostatic properties • Roll shape (cylindrical or interlocking). • Ribbon porosity/solid fraction
    • Hardness/Plasticity • Roll surface design (smooth, knurled, • Ribbon tensile strength/breaking
    • Bulk/Tapped/True density serrated, or pocketed) force
    • Viscoelasticity • Roll gap width (e.g. flexible or fixed) • Throughput rate
    • Brittleness • Roll speed • API polymorphic form and transition
    • Elasticity • Roll pressure
    • Solid form/polymorph • Roller temperature
    • Fines recycled (yes or no, # of cycles)
    Extrusion- • Particle size, distribution • Type of Extruder (screw or basket) • Extrudate
    Spheronization • Fines/Oversize • Screw length, pitch, and diameter o Density
    • Particle shape • Screw channel depth o Length/Thickness/Diameter
    4
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    • Cohesive/Adhesive • Screw blade configuration o Moisture content


    properties • Number of screws (single/dual) o API polymorphic form and
    • Electrostatic properties • Die or screen configuration (e.g. radial or transition
    • Hardness/Plasticity axial) o Content uniformity
    • Bulk/Tapped/True density • Die length/diameter ratio o Throughput
    • Viscoelasticity • Roll diameter (mm) • Pellets after Spheronization
    • Brittleness • Screen opening diameter (mm) o Pellets size and distribution
    • Elasticity • Screw speed (rpm) o Pellets shape factor (e.g. aspect
    ratio)
    • Solid form/polymorph • Feeding rate (g/min)
    o Bulk/Tapped density
    • Type and scale of Spheronizer
    o Flow properties
    • Spheronizer load level o Brittleness
    • Plate geometry and speed o Elasticity
    • Plate groove design (spacing and pattern) o Mechanical strength
    • Air flow o Friability
    • Residence time
    Hot Melt • Particle size, distribution • Screw design (twin/single) • Extrudate density
    Extrusion • Fines/Oversize • Screw speed • Length/Thickness/Diameter
    • Particle shape • Screw opening diameter (mm) • Polymorphic form and transition
    • Melting point • Solid and liquid feed rates • Content uniformity
    • Glass Transition Temp. • Feeder type/design • Throughput
    • Density • Feed rate
    • Solid form/polymorph • No. of Zones
    • Moisture content • Zone temperatures
    • Chilling rate
    Tableting • Particle/granule size and • Type of press (model, geometry, number • Tablet appearance
    distribution of stations) • Tablet weight
    • Fines/Oversize • Hopper design, height, angle, vibration • Weight uniformity
    • Particle/Granule shape • Feeder Mechanism (gravity/forced feed, • Content uniformity
    • Cohesive/adhesive shape of wheels, direction of rotation, number • Hardness/Tablet breaking
    properties of bars) force/Tensile strength
    • Electrostatic properties • Feed frame type and speed • Thickness/dimensions
    • Hardness/Plasticity • Feeder fill depth • Tablet porosity/density/solid fraction
    5
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    • Bulk/Tapped/True density • Tooling design (e.g. dimension, score • Friability


    • Viscoelasticity configuration, quality of the metal) • Tablet defects
    • Brittleness • Maximum punch load • Moisture content
    • Elasticity • Press speed/dwell time • Disintegration
    • Solid form/polymorph • Pre-compression force • Dissolution
    • Moisture • Main compression force
    • Punch penetration depth
    • Ejection force
    • Dwell Time

    Encapsulation • Particle/Granule size and • Machine type • Capsule appearance


    distribution • Machine fill speed • Weight
    • Fines/Oversize • Tamping Force • Weight uniformity
    • Particle/Granule shape • No. Of Tamps • Content uniformity
    • Cohesive/Adhesive • Auger screw design/speed • Moisture content
    properties • Powder bed height • Slug tensile strength
    • Electrostatic properties • Disintegration
    • Hardness/Plasticity • Dissolution
    • Bulk/Tapped/True density
    • Viscoelasticity
    • Brittleness
    • Elasticity
    • Solid form/polymorph
    • Moisture
    Pan Coating • Tablet dimensions • Type of pan coater (conventional or side- • Coating efficiency
    • Tablet defects vented) • Core tablet weight before and after
    • Hardness/Plasticity • Pan (fully perforated or partial perforated) preheating
    • Density • Baffle (design, number, location) • Moisture (gain/loss) during
    • Porosity • Pan load level preheating
    • Moisture content • Pan rotation speed • Environmental equivalency factor
    • Spray nozzle (type, quantity, pattern, • Coated drug product (e.g. tablet or
    configuration, spray pattern) capsule) appearance
    6
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    • Nozzle to bed distance • % weight gain


    • Distance between nozzles • Film thickness
    • Nozzle orientation • Coating (polymer and /or color)
    • Total pre-heating time uniformity
    • Inlet air flow rate, volume, temperature, • Hardness/Breaking force/Tensile
    dew point strength
    • Product temperature • Friability
    • Individual nozzle spray rate • Moisture (gain/loss) during overall
    • Total spray rate process
    • Atomization air pressure • Residual solvent(s)
    • Pattern air pressure • Disintegration
    • Exhaust air temperature, air flow • Dissolution
    • Total coating, curing time and drying time • Tablet defects
    • Visual attributes

    Fluid Bed • Tablet dimensions • Type of fluid bed coater • Coating efficiency
    Coating • Tablet defects • Fluid bed load level • Core tablet weight before and after
    • Hardness/Plasticity • Partition column diameter preheating
    • Density/Porosity • Partition column height • Moisture (gain/loss) during
    • Moisture content • Number of partition columns preheating
    • Air distribution plate type and size • Environmental equivalency factor
    • Filter type and orifice size • Coated drug product (e.g. tablet or
    • Filter differential pressure capsule) appearance
    • Filter shaking interval and duration • % weight gain
    • Spray nozzle (type, quantity, pattern, • Film thickness
    configuration) • Coating (polymer and /or color)
    • Nozzle port size uniformity
    • Total pre-heating time • Hardness/Breaking force/Tensile
    • Spray rate per nozzle strength
    • Total spray rate • Friability
    • Atomization air pressure • Moisture (gain/loss) during overall
    • Inlet air flow rate, volume, temperature, process

    7
    Examples of Pharmaceutical Unit Operations, Material Attributes, Process Parameters, and Quality Attributes (Solid Dosage)

    dew point • Residual solvent(s)


    • Product temperature • Disintegration
    • Exhaust air temperature, air flow • Dissolution
    • Total coating, curing and drying time • Tablet defects
    • Visual attributes
    Laser Drilling • Tablet size/dimensions • Conveyor type • Opening diameter (internal and
    • Polymer type • Conveyor speed external)
    • Membrane thickness • Laser power • Depth
    • Number of pulses • Shape of the opening
    • Type(s) of lens(es)
    • One or two sided
    • Number of holes

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