LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION

Dosage Form: Tablet Date / Time:
Product: Batch No.  :
Previous product: Batch No.  :

Image result for GRANULATION room

Stage areas / room & equipment Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

GRANULATION [Released / Not Released / Hold / Rejected / Not Applicable]
Granulation Area Room ID: _____________________

  • Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.
  • Ensure ‘CLEANED’ label is affixed on each equipment.
  • Ensure updation of Status Board
  • Temperature [24 ± 2°c]
  • Relative Humidity [35 – 50 %]
  • Differential Pressure [10 – 26 Pascal]
CLEANLINESS OF

  • Floor
  • Walls
  • Ceiling
  • Drain
  • Supply air Grills
  • Return air Grills
  • Light Fixtures
  • Waste Bins
  • Container
  • Tools
  • Vacuum cleaner
  • Area below the vibro Sifter.
  • Area below the Turbo sifter
  • Sifter cum multimill.
  • Area below the FBD/FBP.
  • Area below the RMG
  • Area below Tippler
  • Area below OGB
  • Area below Ball mill
  • Area below oscillating Granulator
  • Area below the Quadroco Mill
Vibro Sifter Equipment ID No.: _________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Intermediate Hopper
  • Cleaned Label Present
  • Gasket Integrity
  • Sieve Integrity
  • Discharge Chute
  • Wheels
  • Feed Hopper
Rapid Mixer Granulator Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Bowl
  • Mixer Cone
  • Chopper
  • Charging Port
  • Agitator
  • Mixer Base
  • Cleaned Label Present
 

  • Discharge Valve
  • Gasket Integrity
  • Arm
  • Drain
  • Lid
  • Column
  • Vent filter (Product Specific, if applicable)
 Turbo Sifter cum Multimill Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
Turbo Sifter cum Multimill CLEANLINESS OF

  • Feed hopper
  • Blade assembly
  •  Vent Filter
  • Wheels
  • Rotor
  • Gasket Integrity
  • Discharge Hopper
  • Cleaned Label Present
Quadracomill Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Feed Hopper
  • Discharge Assembly
  • Blade Assembly
 

  • Gasket Integrity
  • Wheels
  • Cleaned label present
Fluidized Bed Dryer/ Fluidized Bed Processor Equipment ID No.: _________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Gasket between the bowl & plenum
  • View glass integrity (intact)
  • Upper & lower Plenum
  • Product Bowl & Mesh.
  • Gasket integrity (intact)
  • Wheels of the bowl
  • Peristaltic Pump
  • Sampling Probe
  • Light assembly
  • Cleaned Label Present
  • Filter Bag
  • Retarding chamber
  • Exhaust end
  • Printer
  • Temperature probe

 

Tippler

 

Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Stand
  • Cleaned Label Present
  • Cone
  • Valve
  • Gasket integrity
Octagonal Blender Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Inside corners of the Blender
  • Cleaned Label Present
  • Rectangular Lid
  • Butterfly Valve
  • Top Closing Lid
  • Shaft & Baffles
  • Gasket Integrity
Ball mill Equipment ID No.: __________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Main chambers
  • Discharge Assembly
  • Ball Assembly
 

  • Gasket Integrity
  • Wheels
  • Cleaned label present
Oscillating Granulator Equipment ID No.: _________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Main chambers
  • Discharge Assembly
  • Wheels
  • Cleaned label present
Vacuum cleaner

 

Equipment ID No.: __________________

  • Ensure the absence of batch document, labels, powder,materials or remnants of previous product or batch.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Hose Pipe
  • Dust resisting filter
  • Dust Collecting Bag
  • Cleaned Label Present

 

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

 

 

 

 

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