| Stage areas /Equipment Name |
Checks |
Checked by
Production
Date & Time |
Counter checked By Quality Assurance
Date & Time |
| COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable] |
| Compression
Cubicle |
Room ID: _____________________
- Ensure the absence of batch documents, labels, materials, powder, tablets, 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
- Container
- Tools
- Waste Bins
- Light Fixtures
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- Area under compression Machine
- Area under the Deduster
- Area under the Metal Detector
- Area under the balances
- Supply air Grills
- Return air Grills
- Vacuum cleaner
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| Compression Machine |
Equipment ID No.:___________________
- Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.
- Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.
- Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.
- Area surrounding the Equipment
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CLEANLINESS OF
- All acrylic component integrity (intact)
- Machine interior & hose pipes
- Lower & Upper punch holes
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| Sleeve of the hopper
Forced Feeder assembly
Pressure Rollers
Discharge Chute
Lower & Upper cam tracks |
Hopper
Turret
Die Cavities
Cleaned label present
Safety Guard |
| Dust Extractor |
Equipment ID No.: ____________________
Ensure the absence of powder. |
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| CLEANLINESS OF
Hose Pipe
Dust Collecting SS pipe
Cleaned Label Present |
| Stage areas / Equipment Name |
Checks |
Checked by
Production
Date & Time |
Counter checked By Quality Assurance
Date & Time |
| Metal Detector |
Equipment ID No.: ____________________
- Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.
- Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.
- Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.
- Area surrounding the Equipment
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| CLEANLINESS OF
Chute assembly
Cleaned label present |
Rejection Flap
Rejection Container
Solenoid cover |
| Deduster |
Equipment ID No._____________________
- Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.
- Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.
- Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.
- Area surrounding the Equipment
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| CLEANLINESS OF
Perforated Plate |
Discharge Chute
Cleaned Label present |
| 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
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| CLEANLINESS OF
Hose Pipe
Dust resisting filter |
Dust Collecting Bag
Cleaned Label Present
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| Weighing Balances |
Instrument ID No.: ____________________
CLEANLINESS OF |
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| Balance Platform
Balance display |
Balances are Calibrated
Area surrounding the balance |
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