LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING

 

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

Image result for conta blender

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

BLENDING [Released / Not Released / Hold / Rejected / Not Applicable]
Blending 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
  • Container
  • Tools
  • Area under the blender
  • Area under the vibro sifter
  • Supply air Grills
  • Return air Grills
  • Light Fixtures
  • Waste Bins
  • Vacuum cleaner
Blender Equipment ID No.: _______________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Inside corners of the Blender
  • Cleaned Label Present
  • Rectangular Lid
  • Butterfly Valve
  • Top Closing Lid
  • Shaft & Baffles
  • Gasket Integrity
Vibro Sifter Equipment ID No.: _______________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
Vibro Sifter CLEANLINESS OF

  • Feed Hopper
  • Sieve Integrity
  • Gasket Integrity
  • Cleaned Label Present
  • Intermediate Hopper
  • Discharge Chute
  • Wheels
Tippler Equipment ID No.: ________________

  • Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.
  • Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.
  • Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.
  • Area surrounding the Equipment
CLEANLINESS OF

  • Stand
  • Cleaned Label Present
  • Cone
  • Valve
  • Gasket integrity
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

  • Hose Pipe
  • 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.

Related image

 

 

 

 

 

Thank you for visit and for more pharma updates click here – https://pharmaguidances.com

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

CIP & SIP OF MANUFACTURING TANK, HOLDING TANK,PRODUCT LINE, FILTER ASSEMBLY & FFS MACHINE

CIP & SIP OF MANUFACTURING TANK, HOLDING TANK,PRODUCT LINE, FILTER ASSEMBLY & FFS MACHINE 1.0   …