SOP for line clearance and role of QA in line clearance at various stages
1.0 OBJECTIVE
To lay down a procedure for line clearance in dispensing, Manufacturing and packing Department prior to start various activity to ensure that the Area and Equipment are clean to avoid previous product or any other for preventing cross contamination.
2.0 SCOPE
The scope of this document is to provide the procedure for giving line clearance prior to start various activity like dispensing, manufacturing like Granulation, Tablet Compression, Capsule Filling, Tablet Coating, packing area and for batch-to-batch and product-to-product change over.
3.0 RESPONSIBILITY
IPQA personnel – To follow the instructions as per SOP
QA head – To ensure compliance of this SOP
4.0 PROCEDURE
4.1 Dispensing area
Inspect the dispensing area after receiving verbal intimation from warehouse personnel; verify the dispensing area as per the Annexure-I along with warehouse personnel.
Note:
In case of any colour is to be dispensed, the line clearance need to be given separately for the same for RLAF and it shall be check for its cleanliness in this case.
4.2 Granulation area.
Inspect the Granulation area after receiving verbal intimation from Production personnel; verify the Granulation area as per the Annexure-II along with Production personnel.
4.3 Compression area.
Inspect the Compression area after receiving verbal intimation from Production personnel; verify the Compression area as per the Annexure-III along with Production personnel.
4.4 Capsule Filling Area.
Inspect the Capsule Filling Area after receiving verbal intimation from Production personnel, verify the Capsule Filling Area as per the Annexure-IV along with Production personnel.
4.5 Coating area
4.5.1 Line clearance for solution preparation room.
Inspect the Solution preparation area after receiving verbal intimation from Production personnel; verify the Solution preparation area as per the Annexure-V along with Production personnel.
4.5.2 Line clearance for autocoator.
Inspect the Coating Area after receiving verbal intimation from Production personnel, verify the Coating Area as per the Annexure-VI along with Production personnel.
4.6 Overprinting operation.
4.7 Inspect the Overprinting Area after receiving verbal intimation from Production personnel, verify the Overprinting Area as per the Annexure-VII along with Production personnel.
4.8 Primary packing
Inspect the Primary Packing Area after receiving verbal intimation from Production personnel, verify the Primary Packing Area as per the Annexure-VIII along with Production personnel.
4.9 Secondary Packing operation
Inspect the Secondary Packing Area after receiving verbal intimation from Production personnel, verify the Secondary Packing Area as per the Annexure-IX along with Production personnel.
4.9 Bulk packing operation
Inspect the Bulk Packing Area after receiving verbal intimation from Production personnel, verify the Bulk Packing Area as per the Annexure-X along with Production personnel.
4.10 Bulk packing secondary operation
Inspect the Secondary Bulk Packing Area after receiving verbal intimation from Production personnel, verify the Secondary Bulk Packing Area as per the Annexure-XI along with Production personnel.
Note:
1. On completion of verification, if the condition is not found satisfactory, instructions to be given to Concern personnel to comply the unsatisfactory points. On compliance of unsatisfactory points, give line clearance to start activity.
2. Checklist for line clearance varied by IPQA should be attached in the BMR/BPR.
5.0 ANNEXURE (S):
Annexure – I: Checklist for Line Clearance – Dispensing area.
Annexure – II: Checklist for Line Clearance – Granulation area
Annexure – III: Checklist for Line Clearance – Compression area
Annexure – IV: Checklist for Line Clearance – Capsule filling
Annexure – V: Checklist for Line Clearance – solution preparation room.
Annexure – VI: Checklist for Line Clearance – coating area.
Annexure – VII: Checklist for Line Clearance – overprinting area.
Annexure – VIII: Checklist for Line Clearance primary packing.
Annexure – IX: Checklist for Line Clearance – secondary packing.
Annexure – X: Checklist for Line Clearance – bulk packing.
Annexure – XI: Checklist for Line Clearance – bulk packing
Annexure – I: Checklist for Line Clearance – Dispensing area.
Product :
Batch Number :
Previous Product :
Previous Batch No. :
RLAF No. :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area / Equipment along with Warehouse personnel.
Sr. No. and Check Points
1. Check the status label of area and verify it with BMR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Check the dispensing area and dispensing booth is dry & visually cleaned and no remnant of the previous product/Batch is present.
4. Verify the logbooks of area and equipment for their completeness of previous activity.
5. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be dispensed.
6. Check the calibration record of weighing balance. Ensure balance verification record updated.
7. Check the cleanliness of dispensing tools and containers to be used for dispensing activity by visual inspection.
8. Check the dedicated scoop for the active material to be dispensed.
9. Check the pressure of Reverse Laminar Air Flow (RLAF) as per requirement.
10. Check that the UV light in pass box is in working condition.
11 Check the waste bin for its cleanliness and replacement of new polythene bag.
12. Cleanliness of return air grills and refitting of removable parts.
13. Cleanliness of surrounding area walls, floor, ceiling, glass window and coving.
14. Check that the BMR is completed with all relevant information.
15. Preventive maintenance status of RLAF.
Annexure – II: Checklist for Line Clearance – Granulation area
Product:
Batch Number:
Previous Product :
Previous Batch No.:
Granulation Area :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
For TYPE: B cleaning follows all points
For TYPE: A cleaning follows Point No.1 to 11.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No and Check Points
1. Check the status label of area and verify it with BMR.
2. Check the availability “cleaned label” of previous product/batch pasted in BMR.
3. Check the availability” product specific label “on the equipment with current product &batch number as status of ready for use.
4. Verify the logbooks of area and equipment for their completeness of previous activity.
5. Check that the area is identified with the product of the running batch.
6. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
7. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be manufactured.
8. Ensure that the components to be calibrated of equipment and area are calibrated (Magnehelic Gauge, Temperature Gauge, Vacuum Gauge, Temperature Indicator, Weighing Balance etc.)
9. Check the waste bin for its cleanliness and replacement of new polythene bag.
10. Check that the BMR is completed with all relevant information.
11. Preventive maintenance status of equipment.
12. Check the all equipment is dry & visually clean and ensure removal of remnants of previous product/batch.
13. Check the area is dry & visually clean and no remnant of the previous product/Batch is present.
14. Check that swab sample of respective equipment is approved.
15. Check the return air grills of air handling unit (AHU) for their cleanliness and refitting of all removable parts.
16. Cleanliness of surrounding area walls, floor, ceiling, glass window,
17. Drain sanitization of area.
18. Vibratory Sifter: Cleanliness of
a. Material Charging Hopper
b. Sieve
c. Sleeves for Sifter and Hopper
d. Material Charging Pipe
e. Cleanliness and Intactness of Gasket of Sieve
f. Dust Collector pipe used during sifting
g. Body of the Sifter
h. Other (If any)
19. Rapid Mixer Granulator: Cleanliness of
a. Impeller and Chopper
b. Inner wall and Inner side of the Lid with Discharge Valve, Vent Assembly
c. Cleanliness and Intactness of the Gasket
d. Cleanliness of the Mixer
e. Other (If any)
20. Oscillating Granulator: Cleanliness of –
a. Rasping Chamber of the Oscillating Granulator
b. Intactness of the Screen
c. Inner side of the Oscillating Granulator along with Discharge
d. Other (If any)
21. Fluid Bed Drier: Cleanliness of
a. Lower plenum, Retarding chamber, Cleanliness and intactness of Gasket of bowl
b. Inside wall and clamp and sieve integrity of the Hollander Mesh
c. Blower Duct of the Bowl
d. Sieve beneath the Hollander Mesh
e. FBD Trolley Racker assembly
f. Correctness and cleanliness of the FBD bags for the product to be used
g. Other (If any)
22. Co Mill: Cleanliness of
a. Granules charging hopper along with the milling chamber
b. Blade assembly of the Co mill
c. Cleanliness and Intactness of the Screen and Gasket
d. Granules Charging hose Pipe
e. Inner portion of the Co mill near the Blades
f. Vacuum system along with the filter bags
g. Other (If any)
23. Octagonal Blender: Cleanliness of
a. Inside, corners of blender.
b. Granules transfer hose pipe along with clamp fittings and its gasket
c. Discharge valve, butterfly valve, gasket and its corners.
d. Other (If any)
24. Multi Mill: Cleanliness of
a. Granules charging hopper along with the milling chamber
b. Blade assembly of the Multi Mill and its shaft.
c. Cleanliness and Intactness of the Screen and Gasket
d. Inner portion of the Multi Mill near the Blades
e. Other (If any)
25. Binder preparation vassals: Cleanliness of
a. Lid and inner surface.
b. Shaft and Blade
c. Other (If any)
26 Cad mill: cleanliness of
a. Granules charging hopper along with the cad milling chamber
b. Blade assembly of the cad Mill and its shaft.
c. Cleanliness and Intactness of the Screen and Gasket
d. Inner portion of the Multi Mill near the Blades
e. Other (If any)
Annexure – III: Checklist for Line Clearance – Compression area
Product :
Previous Product :
Batch Number :
Previous Batch No. :
compression Area :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
For TYPE: B cleaning follows all points
TYPE: A cleaning follows Point No.1 to 14.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No and Check Points
1. Check the status label of area and verify it with BMR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Check the availability “cleaned label” of previous product/batch pasted in BMR.
4. Check the availability” product specific label “on the equipment with current product &batch number as status of ready for use.
5. Verify the logbooks of area and equipment for their completeness of previous activity.
6. Check that the area is identified with the product of the running batch.
7. Check availability of duly labelled bins for disposal of rejects. They should be clean and dry.
8. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be manufactured.
9. Check that weighing balance is thoroughly cleaned and Ensure that the components to be calibrated of equipment and area are calibrated.
10. Check the waste bin for its cleanliness and replacement of new polythene bag.
11. Check that the blend bearing the approved label duly signed by QA person on product label and are ready for compression.
12. Check that the BMR is completed with all relevant information.
13. Preventive maintenance status of equipment.
14. Check for absence of rogue Tablets / Traces of previous product in Hopper, Turret, Force Feeder / Feeder Frame, Y-chute (Extension Piece, Damper, TC Clamps etc), Metal Detector, Weighing Balance, Dust Collection Pendant.
15. Check that the compression area is completely free from materials of previous product.
16. Check tablet compression machine, compression cubicle and respective Bin charging cubicle is dry & visually cleaned and verify that no remnant of the previous product/batch is present.
17. Check that the swab sample of respective equipment is approved.
18. Cleaning below the machine.
19. Check the return air grills of Air Handling Unit (AHU) for their cleanliness and refitting of all removable parts.
20. Cleanliness of surrounding area walls, floor, ceiling, glass window, coving.
Annexure – IV: Checklist for Line Clearance – Capsule filling
Product :
Previous Product :
Batch Number:
Previous Batch No. :
Capsule filling Area :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
For TYPE: B cleaning follows all
TYPE: A cleaning follows Point No.1 to 14.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No. and Check Points
1. Check the status label of area and verify it with BMR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Check the availability “cleaned label” of previous product/batch pasted in BMR.
4. Check the availability” product specific label “on the equipment with current product &batch number as status of ready for use.
5. Verify the logbooks of area and equipment for their completeness of previous activity.
6. Check that the area is identified with the product of the running batch.
7. Check availability of duly labelled bins for disposal of rejects. They should be clean and dry.
8. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be manufactured.
9. Check that weighing balance is thoroughly cleaned and Ensure that the components to be calibrated of equipment and area are calibrated.
10. Check the waste bin for its cleanliness and replacement of new polythene bag.
11. Check that the blend bearing the approved label duly signed by QA person on product label and are ready for capsule filling.
12. Check that the BMR is completed with all relevant information.
13. Preventive maintenance status of equipment.
14. Cleanliness and absence of capsules / Traces of previous product in Empty capsule loader assembly, magazine, Hopper, Dosing disc, Piston guide assembly, pistons, slug and empty capsule collection devices, body and cap bushes, tamping pins, Capsule Dedusting and Polishing machine, Mini capsule sorter machine, Empty capsule sorter machine, Metal Detector, Weighing Balance, Dust Collection Pendant.
15. Check that the capsule filling area is completely free from materials of previous product.
16. Check tablet capsule filling machine, capsule cubicle is dry & visually cleaned and verify that no remnant of the previous product/batch is present.
17. Check that the swab sample of respective equipment is approved.
18. Cleaning below the machine.
19. Check the return air grills of Air Handling Unit (AHU) for their cleanliness and refitting of all removable parts.
20. Cleanliness of surrounding area walls, floor, ceiling, glass window, coving.
Annexure – V: Checklist for Line Clearance – solution preparation room.
Product:
Previous Product:
Batch Number:
Previous Batch No.:
Solution preparation Area:
Date of Line Clearance:
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
For TYPE: B cleaning follows all points
TYPE: A cleaning follows Point No.1 TO 12.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No. and Check Points
1. Check the status label of area and verify it with BMR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Cleanliness of the Coating Solution Preparation Area.
4. Check the availability “cleaned label” of previous product/batch pasted in BMR.
5. Check the availability” product specific label “on the equipment with current product &batch number as status of ready for use.
6. Verify the logbooks of area and equipment for their completeness of previous activity.
7. Check that the area is identified with the product of the running batch.
8. Check availability of duly labelled bins for disposal of rejects. They should be clean and dry.
9. Check that the BMR is completed with all relevant information.
10. Check the waste bin for its cleanliness and replacement of new polythene bag.
11. Approved status of Core Tablets.
12. Preventive maintenance status of equipment.
13. Cleanliness of Coating Solution Preparation Area and Vessel.(The discharge pipe and its joint valve)
14. Check that the swab sample of respective equipment is approved.
15. Area and equipment is free from traces of powder and extraneous materials.
16. Check the return air grills of Air Handling Unit (AHU) for their cleanliness and refitting of all removable parts.
17. Cleanliness of surrounding area walls, floor, ceiling, glass window, coving.
Annexure – VI: Checklist for Line Clearance – Coating area
Product :
Previous Product :
Batch Number :
Previous Batch No. :
Coating Area :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
For TYPE: B cleaning follows all points
TYPE: A cleaning follows Point No.1 to 14.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No. and Check Points
1. Check the status label of area and verify it with BMR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Cleanliness of the Coating Cubicle.
4. Check the availability “cleaned label” of previous product/batch pasted in BMR.
5. Check the availability” product specific label “on the equipment with current product &batch number as status of ready for use.
6. Verify the logbooks of area and equipment for their completeness of previous activity.
7. Check that the area is identified with the product of the running batch.
8. Check availability of duly labelled bins for disposal of rejects. They should be clean and dry.
9. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be manufactured.
10. Check that weighing balance is thoroughly cleaned and Ensure that the components to be calibrated of equipment and area are calibrated.
11. Check the waste bin for its cleanliness and replacement of new polythene bag.
12. Check that the BMR is completed with all relevant information.
13. Preventive maintenance status of equipment.
14. Check for absence of rogue Tablets / Traces of previous product in solution charging tank & tubes, coating pan & baffles, attached ducting, inlet and exhaust lines, site guard, gun assembly.
15. Check that the coating cubical is completely free from materials/labels of previous product.
16. Cleanliness of Coating Cubicle, Auto-coater.
17. Area and equipment is free from traces of powder and extraneous materials.
18. Check that cleaning of drain pipe & its valve.
19. Cleanliness of nozzle assembly, tubes.
20. Check that the swab sample of respective equipment is approved.
21. Check the return air grills of Air Handling Unit (AHU) for their cleanliness and refitting of all removable parts.
22. Cleanliness of surrounding area walls, floor, ceiling, glass window, coving.
Annexure – VII: Checklist for Line Clearance – Overprinting area.
Product :
Previous Product :
Batch Number:
Previous Batch No.:
Overprinting cubicle:
Date of Line Clearance:
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
Sr. No. and Check Points
1. Status Labelling of the room and verify it with BPR.
2. Cleanliness of Overprinting room.
3. Cleanliness of Overprinting machine.
4. Verify the logbooks of area and equipment for their completeness of previous activity.
5. Check that the stereo and show box / label of previous batch removed from the area.
6. Absence of remnant of packing material of previous product / any other product/batch.
7. Cleanliness of waste bins, Rejection bins & other containers.
8. Preventive maintenance status of equipment.
9. Cleanliness below the machine.
Annexure – VIII: Checklist for Line Clearance primary packing.
Product :
Previous Product :
Batch Number :
Previous Batch No. :
Primary packing Area :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
For TYPE: B cleaning follows all points
TYPE: A cleaning follows Point No.1 to 15.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No. and Check Points
1. Check the status label of area and verify it with BPR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Cleanliness of Blister packing machine and deblistering machine.
4. All rejected blisters, foil, and packing material removed from the machine area.
5. Verify the logbooks of area and equipment for their completeness of previous activity.
6. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be packed.
7. Check that the stereo of previous batch is removed from the area.
8. Check that the BPR is completed with all relevant information.
9. Ensure that the components to be calibrated of equipment and area are calibrated.
10. Check that the product bearing approved label is duly signed by QA person and is ready for primary packing.
11. Cleanliness of waste bin / rejection bins / containers.
12. Absence of product in tool box.
13. Preventive maintenance status of equipment.
14. Check for absence of rouge tablets /capsules of previous product/batch in Hopper, Vibrating feeding pan, Feeding chute, Brush feeder, Sweep brush, Guide track, Forming station, Sealing station, Embossing / cutting tool, Deblistering machine.
15. Check for absence of rouge tablets /capsules in dust collector pipes.
16. Check that the swab sample of respective equipment is approved.
17. All nuts and bolts properly fit on AHU grills & risers.
18. Cleanliness below the machine.
19. Cleanliness of surrounding area walls, floor, ceiling, glass window,
20. All remnants of previous product removed.
Annexure – IX: Checklist for Line Clearance – secondary packing.
Product :
Previous Product :
Batch Number :
Previous Batch No. :
Secondary packing area :
Date of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area /Equipment along with Production personnel.
Sr. No. and Check Points
1. Labelling status of the area and verify it with BPR.
2. Check area is dry & visually cleaned and verify that no remnant of the previous product/batch is present.
3. Verify the logbooks of and equipment for their completeness of previous activity.
4. Check that the show box / label of previous batch removed from the area.
5. Cleanliness of waste bins, Rejection bins & other containers.
6. Cleanliness of below conveyor belt & adjacent area.
7. Cleanliness of shrink wrapping machine.
8. Check that weighing balance is thoroughly cleaned and duly calibrated.
9. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
10. Check that the BPR is completed with all relevant information.
11. Preventive maintenance status of equipment.
Annexure – X: Checklist for Line Clearance – bulk packing of primary packing area.
Product :
Previous Product :
Batch No. :
Previous Product batch No. :
Cubicle No. / Line No. :
Date/Time of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area/Equipment along with Production personnel.
Write “Not Applicable” (NA) wherever the point is not applicable.
Sr. No. and Check points
1. Check the status label of area and verify it with BPR.
2. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
3. Cleanliness of Bulk packing machine.
4. Verify the logbooks of area and equipment for their completeness of previous activity.
5. Check the environmental conditions (Temperature and % Relative Humidity) are within the specified condition as required by the product to be manufactured.
6. Check that the BPR is completed with all relevant information.
7. Check that the product bearing approved label is duly signed by QA person and is ready for primary packing.
8. Preventive maintenance status of equipment.
9. Cleanliness of conveyer belt.
10. Check that the swab sample of respective equipment is approved.
11. Cleaning below the machine.
12. Cleanliness of waste bins, rejection bins & all other containers. Fresh poly bag put inside.
13. Unscrambler: Cleanliness & absence of bottle.
a. Bottle Hopper
b. Sorter Disc
c. Bottle Delivery Chute
d. Conveyor Belt
e. Misfeed Bottle tray
14. Tablet/Capsule Counter and filler machine: Cleanliness & absence of rouge tablet/ capsule.
a. Hopper
b. Conveyor Top and Bottom
c. Discharge Chute and Funnel
d. Product chamber
e. Machine Base
f. Rejection Tray
g. Conveyor Belt
h. Other (If any)
15. Checkweigher: Cleanliness of
a. Conveyor Belt
b. Rejection Chamber
c. Other (If any)
16. Cotton inserter: Cleanliness of
a. Cotton Container
b. Cotton Rollers and Guides
c. Cotton Tubes
d. Machine Base
e. Turn Table
f. Conveyor Belt
e. Other (If any)
17. Capping Unit: Cleanliness & absence of cap.
a. Cap Elevator and Cap Hopper
b. Cap Discharge Chute
c. Torque Station and Belt
d. Machine Base/Turn Table
e. Conveyor Belt
f. Rejection box.
g. Other (If any)
18. All nuts and bolts properly fit on AHU grills & risers.
19. Cleanliness of walls, floor, ceiling, window glass, coving and surrounding area of bulk packing.
20. All remnants of previous product removed.
Annexure – XI: Checklist for Line Clearance – bulk packing of secondary packing area.
Product:
Previous Product:
Batch No.:
Previous batch No.:
Line No.:
Date/Time of Line Clearance :
Quality Assurance personnel shall check the following point for Line Clearance of the Area / Equipment along with Production personnel.
Sr. No. and Check points
1. Check the status label of area and verify it with BPR.
2. Check area is dry & visually cleaned and verify that no remnant of the previous product/batch is present.
3. Cleanliness of below conveyor belt & adjacent area.
4. Cleanliness of packing area.
5. Absence of remnant of any previous product / batch, Packing Material, stereo, etc in the area.
6. Cleanliness of conveyer belt.
7. Verify the logbooks of area and equipment for their completeness of previous activity.
8. Cleanliness of waste bins, Rejection bins & other containers.
9. Induction Sealing Unit: Cleanliness of
a. Sealing Head / conveyor belt
b. Rejection Tray
c. Other (If any)
Re-torque Unit: Cleanliness of
a. Torque Station and Belt
b. Rejection Tray
c. Other (If any)
10. Labelling Unit: Cleanliness of
a. Winding and unwinding stations
b. Wrapping Belt
c. Machine Base
d. Rejection Tray
e. Conveyor Belt
f. Other (If any)
11. Check that the BPR is completed with all relevant information.
12. Check the differential pressure of area by observing magnehelic gauge and ensure that it is within the specified limit.
13. Preventive maintenance status of equipment.