SOP on Line Clearances
- OBJECTIVE :To ensure that the area and equipment, required for the manufacturing and packing activities of pharmaceutical products are free from any potential sources of cross contamination/ mix-ups.
- SCOPE:The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities.
- Responsibility: Officer/ Executive of respective department and IPQA shall be responsible to follow the procedure mentioned in this SOP.
- ACCOUNTABILITY: Department Head and Quality Assurance Head shall be accountable for compliance of this SOP
- Abbreviations and Definitions
- IPQA: in – process quality Assurance
Metformin Hydrochloride Tablet 500 mg (drugsformulations.com)
- PROCEDURE
- Cleaned the equipment and area as per respective SOP.
- Affix ‘CLEANED’ label on each cleaned equipment.
- Fill the area status board.
- Before starting any further activity verify the checkpoints mentioned in the annexure no. 01, for giving line clearance by respective department and IPQA.
- If any discrepancy is observed repeat the previous step.
- Write the details of previous product and next product [Name & Batch No.] at each different area.
- Line Clearance Manufacturing Area:
- During the line clearance of any Manufacturing Area following points shall be covered to check and verify in annexure no. 01.
- Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to previous stage.
- Mentioned the Room ID No.
- Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
- Ensure updation of status board & ‘CLEANED’ label is affixed on each cleaned equipment. [All equipment shall be clean]
- Room conditions as Temperature, Relative Humidity and Differential Pressure are must be within limits.
- Area status board for cleanliness shall include the clean status of return air raisers, supply air raisers, floor, ceiling, walls, drainage, light fixtures, dustbins, Containers, Tools, Vacuum cleaner, area surrounding the equipment and area surrounding the balances.
- If all above mentioned points are found satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- Line Clearance RLAF:
- During the line clearance of any RLAF following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Room ID No.
- Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
- Ensure updation of status board/status label.
- Differential Pressure across pre-filters and HEPA filters are must be within limits.
- Ensure cleanliness of Area, Cleanliness of Balances, Calibration of Balances, Cleanliness of Supply Air Grills of RLAF unit, Cleanliness of Return Air Grills of RLAF unit, Status label on IPC/bin/ balances/dispensing tools.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- Line Clearance Manufacturing Equipment:
- During the line clearance of any Manufacturing Equipment following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Equipment ID No.
- Ensure the absence of batch documents, labels, materials, powder, tablets or any remnants of previous product or batch and traces of water surrounding the equipment.
- Ensure the absence of batch documents; labels, materials, powder, tablets or any remnants of previous product or batch and traces of water on each dismantle part of the equipment.
- Ensure the absence of materials, powder, tablets or any remnants of previous product or batch and traces of water on each critical part of the equipment.
- Critical & Dismantle parts of all equipment are varying from equipment to equipment. Name of the critical & dismantle parts of all equipment are mentioned individually in the line clearance checklist Annexure no. 01.
- Weighing balances and Analytical balances of each area shall be cleaned and calibrated as per their frequency.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- Line Clearance Packing Cubical or Line:
- During the line clearance of Packing Cubical or line following points shall be covered to check and verify in annexure no. 01.
- Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to previous stage.
- Mentioned the Room ID No./ Line No.
- Ensure the absence of batch documents, labels, materials [Primary/Secondary/Tertiary packing materials] or any remnants of previous product or batch.
- Ensure updation of status board & ‘CLEANED’ label is affixed on each cleaned equipment.
- Room conditions as Temperature, Relative Humidity and Differential Pressure are must be within limits.
- Area status board for cleanliness shall include the clean status of return air raisers, supply air raisers, floor, ceiling, walls, drainage, light fixtures, dustbins, Containers, Tools, Vacuum cleaner, area surrounding the equipment.
- Ensure that the absence of tablets, strips, blisters, plain aluminum foil, printed aluminum foil, PVC foil, PVDC foil of previous batch or product and oil/water leakages.
- Above mentioned materials may be excess remaining or rejected during machine setting or on line rejected.
- Ensure that the absence of the recoverable/rejected/defoiled strips, blisters or tablets.
- Ensure that the overprinting stereos of previous product or batch are destroyed.
- Batch Manufacturing Record of current batch, which is to be started, shall be completed up to production head sign and reviewed by IPQA.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- Line Clearance Packing Equipment:
- During the line clearance of Packing Equipment following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Equipment ID No.
- Ensure the absence of batch documents, labels, materials, powder, tablets or any remnants of previous product or batch and traces of water surrounding the equipment.
- Ensure the absence of batch documents; labels, materials, powder, tablets, strips, blisters or any remnants of previous product or batch and traces of oil/water on each dismantle part or surrounding the equipment.
- Ensure the absence of materials, powder, tablets or any remnants of previous product or batch and traces of water on each critical part of the equipment.
- Critical & Dismantle parts of all equipment are varying from equipment to equipment. Name of the critical & dismantle parts of all equipment are mentioned individually in the line clearance checklist Annexure no. 01.
- Recoverable, Rejected or defoiled strips/blisters/tablets of previous batch or product must be removed.
- Weighing balances and Analytical balances of each area shall be cleaned and calibrated as per their frequency.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- Entry of primary, secondary & tertiary packing materials can be acceptable.
- Machine setting and removal of proof shall be accepted. Production department shall sign proof, but machine could not run before getting line clearance from IPQA.
- IPQA shall verify the proofs and can give final line clearance to start the batch packing only after getting the result of previous stage from quality control department.
- In case if manual coding is to be carried out, for cartons and / or labels, following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Room ID No.
- Ensure the absence of batch documents, labels, materials [Primary/Secondary/Tertiary packing materials] or any remnants of different product or batch.
- Ensure updation of status board or ‘CLEANED’ label is affixed.
- Area status board or affixed ‘CLEANED’ label for cleanliness shall include the clean status of floor, ceiling, walls, light fixtures, dustbins, Cage and surrounding area.
- Ensure that the absence of printed, overprinted cartons of any different batch or product.
- Ensure that the overprinting stereos of previous product or batch are destroyed.
-
- Forms and Records.
- Line Clearance Checklist of Area and Equipment for Manufacturing and related Area- Annexure -I
- Distribution
- Master Copy- Documentation Cell (QA)
- Controlled Copies-Production and Quality Assurance
- History
Date | Revision
Number |
Reason for revision |
– | 00 | New SOP |
MASTER FORMULA OF PHENYLEPHERINE HYDROCHLORIDE,CETRAZINE DIHYDROCHLORIDE ,ARACETAMOL & CAFFEINE ANHYDROUS TABLETS (drugsformulations.com)
Annexure-I
Line Clearance Checklist of Area and Equipment for Manufacturing and related Area
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous Product: | Batch No. : |
Dispensing Room:
Sr. No. | Check points | Observations | Done
By |
Checked by | Verified
By QA |
|
Production | Warehouse | |||||
DISPENSING AREA [Released / Not Released / Hold / Rejected / Not Applicable] | ||||||
Room Identification number: | ||||||
1 | Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch. | |||||
2 | Ensure updation of status board & ‘CLEANED’ label is affixed on each equipment. | |||||
3 | Cleanliness of Supply Air Grills of AHU. | |||||
4 | Cleanliness of Return Air Grills of AHU. | |||||
5 | Cleanliness of floor, ceiling, walls, drainage, light fixtures, dustbins, containers, tools, vacuum cleaner. | |||||
6 | Area surrounding the dustbins, containers, tools and Balances. | |||||
7 | Temperature [24 ± 2°c] | |||||
8 | Relative Humidity [35 – 50 %] | |||||
9 | Differential Pressure [10 – 26 Pascal] | |||||
10 | Updation on status board |
Dispensing Booth:
Sr. No. | Check points | Observations | Done
By |
Checked by | Verified
By QA |
|||
Active | Excipient | Colour | Production | Warehouse | ||||
Room Identification number: | ||||||||
1 | Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch. | |||||||
2 | Ensure updation of status board/ status label on RLAF. | |||||||
3 | Ensure ‘CLEANED’ label is affixed on each cleaned equipment/tools/balances/IPC/Bins. | |||||||
4 | Cleanliness of Supply Air Grills of RLAF. | |||||||
5 | Cleanliness of Return Air Grills of RLAF. | |||||||
6 | Cleanliness of floor, RLAF walls, light fixtures, containers, tools and balances. | |||||||
7 | Calibration of balances | |||||||
8 | Pressure differential across pre-filters. | |||||||
9 | Pressure differential across HEPA filters. |
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / room & equipment | Checks | Checked By | Verified By | |
Production | QA | |||
Vacuum cleaner | Equipment ID No.: ____________________
|
|||
ENSURE THE CLEANLINESS OF | ||||
|
|
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
Stage areas / room & equipment | Checks | Checked By | Verified By | |
Production | QA | |||
BINDER PREPARATION [Released / Not Released / Hold / Rejected / Not Applicable] | ||||
Binder Preparation Area | Room ID: ____________________
|
|||
ENSURE THE CLEANLINESS OF | ||||
|
|
|||
Steam Jacketed Vessel | Equipment ID: ____________________
CLEANLINESS OF
|
|||
GRANULATION [Released / Not Released / Hold / Rejected / Not Applicable] | ||||
Granulation Area | Room ID: _____________________
|
|||
ENSURE THE CLEANLINESS OF | ||||
|
|
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / room & equipment | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||
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 |
||||||
CLEANLINESS OF
Intermediate Hopper Cleaned Label Present Gasket Integrity |
Sieve Integrity
Discharge Chute Wheels Feed Hopper |
||||||
Rapid Mixer Granulator | 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
Bowl Mixer Cone Chopper Charging Port Agitator Mixer Base Cleaned Label Present |
Discharge Valve Gasket Integrity Arm Drain Lid Column |
||||||
Vent filter (Product Specific, if applicable) | |||||||
Turbo Sifter cum Multimill | 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 |
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / room & equipment | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||
Turbo Sifter cum Multimill | CLEANLINESS OF
Feed hopper Blade assembly Vent Filter Wheels |
Rotor
Gasket Integrity Discharge Hopper Cleaned Label Present |
|||||
Quadracomill | 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
Feed Hopper Discharge Assembly Blade Assembly |
Gasket Integrity Wheels Cleaned label present |
||||||
Fluidized Bed Dryer/ Fluidized Bed Processor | 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
Gasket between the bowl & plenum View glass integrity (intact) |
|||||||
Upper & lower Plenum
Product Bowl & Mesh. Gasket integrity (intact) Wheels of the bowl Peristaltic Pump Sampling Probe Light assembly |
Cleaned Label Present
Filter Bag Retarding chamber Exhaust end Printer Temperature probe |
||||||
Tippler
|
Equipment ID No.: ______________________
Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. Area surrounding the Equipment |
||||||
CLEANLINESS OF
Stand Cleaned Label Present |
Cone
Valve Gasket integrity |
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / room & equipment | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
|||||
Octagonal 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 |
|||||||
Ball mill | 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
Main chambers Discharge Assembly Ball Assembly |
Gasket Integrity Wheels Cleaned label present |
|||||||
Oscillating Granulator | 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
Main chambers Discharge Assembly |
Wheels Cleaned label present |
|||||||
Vacuum cleaner
|
Equipment ID No.: ____________________
Ensure the absence of batch document, labels, powder,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.
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 |
||||||
Octagonal 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.
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] |
||||||
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 |
Hopper
Turret Die Cavities Cleaned label present Safety Guard |
||||||
Dust Extractor | Equipment ID No.: ____________________
Ensure the absence of powder. |
||||||
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 |
||||||||||
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 |
||||||||||
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
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.
Stage areas / Equipment Name | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
|||||
COATING [Released / Not Released / Hold / Rejected / Not Applicable] | ||||||||
Coating Room | Room ID No.: ____________________
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 q Waste Bins Light Fixtures |
Area under coating Machine
Area under the Colloidal mill Area under the coating solution preparation tank Area under the coating solution storage tank Area under the balance Supply air Grills Return air Grills |
|||||||
Auto-coater | 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 or colour 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
Exhaust hood Base of the Dosing Pump Cleaned Label Present Connecting Pipes View Glass Integrity (intact) Temperature probe Sampling Probe Light assembly |
Hot air blower Spray Guns Baffles Cabinet Pan Spray gun Bar PLC assembly Peristaltic Pump |
|||||||
Colloid Mill | Equipment ID No.: _______________
Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch and traces of water or colour. |
Colloid Mill | CLEANLINESS OF
Cleaned Label Present Rotor |
Hopper
Hose pipe Stator |
||||||
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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