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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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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