Category: Audit Management

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION

Granulation Area

1. Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.
2. Ensure ‘CLEANED’ label is affixed on each equipment.
3. Ensure updating of Status Board for
4. Temperature [°c], Relative Humidity [%], Differential Pressure [Pascal]
5. CLEANLINESS of Floor Walls, Ceiling, DrainContainer, Tools, Waste Bins, Light Fixtures.

Vibro Sifter

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Intermediate Hopper Cleaned Label Present Gasket Integrity.
3. CLEANLINESS OF Sieve Integrity Discharge Chute, Wheels Feed Hopper.

Rapid Mixer Granulator

1. CLEANLINESS OF BowlMixer, ConeChopper, Charging Port Agitator Mixer Base and Cleaned Label Present.
2. CLEANLINESS OF Discharge Valve, Gasket Integrity Arm Drain and Lid Column.

Turbo Sifter cum Multimill

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Feed hopper Blade assembly Vent Filter Wheels.

Quadracomill

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Feed Hopper Discharge Assembly Blade Assembly.
4. CLEANLINESS OF Gasket Integrity Wheels Cleaned label present.

Fluidized Bed Dryer/Fluidized Bed Processor

1. CLEANLINESS OF Gasket between the bowl & plenum View glass integrity (intact)
2. Cleaned Label Present, Filter Bag, Retarding chamber, Exhaust end Printer Temperature probe.
3. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
4. CLEANLINESS OF Area surrounding the Equipment.

Tippler

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Stand Cleaned Label Present

Octagonal Blender

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Inside corners of the Blender Cleaned Label Present Rectangular Lid and cleaned label present.

Ball mill

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Main chambers Discharge Assembly Ball Assembly and cleaned label present.

Oscillating Granulator

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Main chambers Discharge Assembly and cleaned label present.

Vacuum cleaner

1. Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part and on each critical part.
2. CLEANLINESS OF Area surrounding the Equipment.
3. CLEANLINESS OF Hose Pipe Dust resisting filter. (updated on 21/12/2020)