LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

Dosage Form: Date / Time:
Product: Batch No.  :
Previous product: Batch No.  :

Image result for BINDER PREPARATION

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]
CLEANLINESS OF

  • Floor
  • Walls
  • Ceiling
  • Drain
  •  Supply air Grills
  • Containers
  • Tools
  • Vacuum cleaner
  • Waste Bins
  • Light Fixtures
  • Return air Grills
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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