LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION

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

Image result for compression machine

Stage areas /Equipment Name

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable]

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]

CLEANLINESS OF

Floor
Walls
Ceiling
Drain
Container
Tools
Waste Bins
Light Fixtures

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

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

CLEANLINESS OF

All acrylic component integrity (intact)
Machine interior & hose pipes
Lower & Upper punch holes

Sleeve of the hopper

Forced Feeder assembly

Pressure Rollers

Discharge Chute

Lower & Upper cam tracks

Die Cavities

Cleaned label present

Safety Guard

Dust Extractor

Equipment ID No.: ____________________

Ensure the absence of powder.

CLEANLINESS OF

Dust Collecting SS pipe

Cleaned Label Present

Stage areas / Equipment Name

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

CLEANLINESS OF

Chute assembly

Cleaned label present

Rejection Flap

Rejection Container

Solenoid cover

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

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

CLEANLINESS OF

Dust resisting filter

Dust Collecting Bag

Cleaned Label Present

Weighing Balances

Instrument ID No.: ____________________

CLEANLINESS OF

Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

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