LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION
Dosage Form: |
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Date / Time: |
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Product: |
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Batch No. : |
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Previous product: |
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Batch No. : |
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Stage areas / room & equipment |
Checks |
Checked by
Production
Date & Time |
Counter checked By Quality Assurance
Date & Time |
BINDER PREPARATION [Released / Not Released / Hold / Rejected / Not Applicable] |
Binder Preparation 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
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- Containers
- Tools
- Vacuum cleaner
- Waste Bins
- Light Fixtures
- Return air Grills
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Steam Jacketed Vessel |
Equipment ID: ____________________
CLEANLINESS OF
- Ensure the absence of batch documents, labels, materials, paste, traces of water or remnants of previous product or batch.
- Cleaned Label Present
- Area surrounding the Equipment
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