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Writer's picturePharma Explorer

Common Tablet Defects by Parvez Officer QA

Updated: Nov 7, 2021

STICKING


Probable Causes

  • Punch face Condition

  • Excessive Moisture

  • Ambient Conditions (Temperature and Humidity)

  • Deficient Formulation and/or process

  • Punch tip worn, burred or have J-hook present

  • Insufficient compaction force


Common Corrective Actions

  • Polish puch face/consider matte finish

  • Check moisture content of granule

  • increase compaction force

  • Rework/replace punch



PICKING


Probable Causes

  • Punch face condion

  • Excessive moisture

  • Ambient condition (Temperature and Humidity)

  • Deficient Formulation and/or process

  • Punch tip worn, burred or have J hook present

  • Insufficient compaction force

  • Poor embossing design


Common Corrective Actions

  • Polish puch face/consider matte finish

  • Check moisture content of granule

  • Increase compaction force

  • Rework/replace punch

  • Redesign embossing (Consider pre pick islands and taper peninsulas of embossing)


LAMINATION


Probable Causes

  • Air entrapment

  • Excessive pre-compression

  • Exessive main compression

  • Ringed (worn) die bore

  • Punch tip worn, burred or have J hook present

  • Exvessive fines


Common Corrective Actions

  • Compress higher in die

  • Taper die

  • Reduce pre compression

  • Reduce main compression

  • Reverse or replace die


CAPPING

Probable Causes

  • Air Entrapment

  • Excessive pre-compression

  • Exessive main compression

  • Ringed (worn) die bore

  • Punch tip worn, burred or have J hook present

  • Exvessive fines


Common Corrective Actions

  • Compress higher in die

  • Taper die

  • Reduce pre compression

  • Reduce main compression

  • Reverse or replace die

SPLITTING


Probable Causes


Common Corrective Actions

  • Reduce pre-compression

  • Reduce main compression

  • Reduce fines


EDGE EROSION


Probable Causes

  • Unequal distribution of granulation in die bores

  • Particle segregation or stratification in hopper

  • Low moisture content

  • Poor tablet design

  • Poor compaction


Common Corrective Actions

  • Ensure raw materia quality

  • Balance/level tablet press

  • Set scrapper correctly

  • Minimize fill depth

  • Redesign tablet geometry


DISCOLORATION


Probable Causes

  • Excessive pressure

  • Poor tablet design

  • Frmulation component readily oxidized


Common Corrective Actions

  • Reduce main compression force

  • Evaluate tablet design

  • Identify discoloration and take action



DARK SPECS


Probable Causes

  • Dust, dirt or press lubrication in granulation

  • Excessive amount of lubrication on upper punch

  • Improper lubrication type on upper punch

  • Punch tip worn, burred or have J-hook present

  • worn die bore

  • Improper tip-to-die clearance


Common Corrective Action

  • Clean press more frequently

  • Use proper punch drip cups and key-way fillers

  • Rework/replace punches

  • Replace dies

  • Reevaluate die taper/upper punch penetration



SCORCHED BELLY BAND


Probable Causes


Common Corrective Action

  • Minimize depth of fill

  • Reformulate

  • Reduce lubricant blend time

  • Taper dies



CHIPPING


Probable Cuases

  • Punch tip worn, burred or have J-hook

  • Poor tooling design

  • Upper punch misalignment



Common Corrective Action

  • Rework/replace punches

  • Preload shaped tooling properly during installation

  • Inspect turret for excessive punch guide wear, key-way wear and die pocket wear


DOUBLE IMPRESSION (Round tablets only)


Probable Causes

  • Free rotation of either upper or lower punch

- After pre-compression - After main compression

- During tablet ejection


Common Corrective Action

  • Add keys on round puches

  • Use punch retainers/breakers




Probable Causes

  • Inconsistent lower punch bight

  • Granulation lost/gained after dosing

  • Over filling/under filled feeder

  • Worn improper scrapper adjustment

  • Non uniform lower punch lengths


Common Corrective Action

  • Check/replace lower punch retainer

  • Check/replace lower punch scrapper seals

  • Adjust feeder speed

  • Reduce recirculated powder

  • Chec/replace scrapper

  • Check lower punch working lengths


 

An article by Parvez

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