| 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]
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CLEANLINESS OF
- Floor
- Walls
- Ceiling
- Drain
- Supply air Grills
- Return air Grills
- Light Fixtures
- Waste Bins
- Container
- Tools
- Vacuum cleaner
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- 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
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| 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
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CLEANLINESS OF
- Intermediate Hopper
- Cleaned Label Present
- Gasket Integrity
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- Sieve Integrity
- Discharge Chute
- Wheels
- Feed Hopper
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| 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
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CLEANLINESS OF
- Bowl
- Mixer Cone
- Chopper
- Charging Port
- Agitator
- Mixer Base
- Cleaned Label Present
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- Discharge Valve
- Gasket Integrity
- Arm
- Drain
- Lid
- Column
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- Vent filter (Product Specific, if applicable)
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| 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
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| Turbo Sifter cum Multimill |
CLEANLINESS OF
- Feed hopper
- Blade assembly
- Vent Filter
- Wheels
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- Rotor
- Gasket Integrity
- Discharge Hopper
- Cleaned Label Present
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| 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
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CLEANLINESS OF
- Feed Hopper
- Discharge Assembly
- Blade Assembly
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- Gasket Integrity
- Wheels
- Cleaned label present
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| 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
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CLEANLINESS OF
- Gasket between the bowl & plenum
- View glass integrity (intact)
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- Upper & lower Plenum
- Product Bowl & Mesh.
- Gasket integrity (intact)
- Wheels of the bowl
- Peristaltic Pump
- Sampling Probe
- Light assembly
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- Cleaned Label Present
- Filter Bag
- Retarding chamber
- Exhaust end
- Printer
- Temperature probe
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| Tippler
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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
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CLEANLINESS OF
- Stand
- Cleaned Label Present
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- Cone
- Valve
- Gasket integrity
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| 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
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CLEANLINESS OF
- Inside corners of the Blender
- Cleaned Label Present
- Rectangular Lid
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- Butterfly Valve
- Top Closing Lid
- Shaft & Baffles
- Gasket Integrity
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| 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
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CLEANLINESS OF
- Main chambers
- Discharge Assembly
- Ball Assembly
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- Gasket Integrity
- Wheels
- Cleaned label present
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| 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
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CLEANLINESS OF
- Main chambers
- Discharge Assembly
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- Wheels
- Cleaned label present
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| Vacuum cleaner
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Equipment ID No.: __________________
- Ensure the absence of batch document, labels, powder,materials or remnants of previous product or batch.
- Area surrounding the Equipment
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CLEANLINESS OF
- Hose Pipe
- Dust resisting filter
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- Dust Collecting Bag
- Cleaned Label Present
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