LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING

 

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

Image result for conta blender

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

BLENDING [Released / Not Released / Hold / Rejected / Not Applicable]
Blending 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
  • Container
  • Tools
  • Area under the blender
  • Area under the vibro sifter
  • Supply air Grills
  • Return air Grills
  • Light Fixtures
  • Waste Bins
  • Vacuum cleaner
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
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
Vibro Sifter CLEANLINESS OF

  • Feed Hopper
  • Sieve Integrity
  • Gasket Integrity
  • Cleaned Label Present
  • Intermediate Hopper
  • Discharge Chute
  • Wheels
Tippler 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

  • Stand
  • Cleaned Label Present
  • Cone
  • Valve
  • Gasket integrity
Vacuum cleaner Equipment ID No.: ________________

  • Ensure the absence of batch documents, labels, powder, tablets, 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

 

Weighing Balances Instrument ID No.: _______________

CLEANLINESS OF

  • Balance Platform
  • Balance display
  • Balances are Calibrated
  • Area surrounding the balance

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

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