Cleaning and Replacement of HVAC Clean Air Filters

Cleaning and Replacement of HVAC LAF Other Clean Air Filters and Monitoring of HEPA Filters

OBJECTIVE :
1.1 To lay down a procedure for Procurement, Storage , Cleaning , Replacement of HVAC / LAF / Other clean Air Filters and Monitoring of HEPA Filters.

2.0. SCOPE :
2.1 This procedure is applicable for Procurement, Storage, Cleaning, Spare Pre Filter Replacement, Replacement of HVAC / LAF /Other clean Air Filters and Monitoring of HEPA Filters in Pharmaceuticals

3.0. RESPONSIBILITY :
3.1 Engineering staff shall be responsible for Procurement, Storage, Spare Pre Filter Replacement, Replacement of HVAC/LAF/Dust Collector Filters and Cleaning of HVAC /LAF/ Dust Collector Filters.
3.2 Sterile Product Department staff shall be responsible for Cleaning of LAF / Tunnel Filters in the department
3.3 QC Department staff shall be responsible for Cleaning of LAF / HVAC Return riser Filters in the department.
3.4 Warehouse Department staff shall be responsible for Cleaning of LAF / HVAC Return riser Filters in the
department
3.5 Department Executive / Officer shall be responsible to verify the work and keep the records of Filters for the Department.

4.0. ACCOUNTABILITY: Head of the concerned Department.

5.0. PROCEDURE: Procurement, storage, cleaning, replacement, disposal and monitoring.
5.1 PROCUREMENT OF FILTERS :
5.1.1 Filters shall be procured on the basis of Filter’s failed in validation and Filter replacement frequency.
5.1.2 Indent the filter with all specifications related to its Efficiency, Type, Grade, Pr. Drop , Flow with request
Note for Filter’s testing certificates for its integrity and specifications.
5.2. STORAGE OF FILTERS :
5.2.1 At receiving time , check filters packing ,its integrity and Keeping position. If not found satisfactory, reject it and inform to Purchase department.
5.2.2 If filters are satisfactory then transfer to storage area with ID code /No. as per Annex – I
5.2.3 Always keep filters in upright position in store. All Filters shall be stored in Dry and Ambient condition.
5.2.4 Record Filter receive / issue in Annex-II for HVAC / LAF/Other Clean air filter receipt and issuance.
5.3. CLEANING OF HVAC & LAF / TUNNELS PRE FILTERS :
5.3.1 Perform the cleaning of filter only in not working hours after consultant with concerned department.
5.3.2 Switch off the system of which filters to be cleaned and display `Under Maintenance’ board.
5.3.3 Open the inspection window / door of filter plenum or Return duct riser Grill if applicable.
5.3.4 Remove the pre filters from their housing and put it into the polythene bag.
5.3.5 Close the inspection window / door of filter plenum or system .
5.3.6 Take the filters to `Filter Washing’ area.
5.3.7 Remove the filter from polythene bag and placed on Filter trays by Opening the window / door of Filter Cleaning Tunnel.
5.3.8 After placing the filter on trays closed the window / door of Filter Cleaning Tunnel.
5.3.9 Open the compressed air valve of Filter Cleaning Tunnel and Ensure that air pressure should be 2 – 4 Kg/cm2
5.3.10 Open the Potable Waterline valve of Filter Cleaning Tunnel.
5.3.11 Ensure the Auto/Manual Rotary button in the position on Auto & then Switch to START Button of Filter Cleaning Tunnel from Control Panel.
5.3.12 Filter Cleaning Tunnel starts in Auto Mode and clean the filter automatically.
5.3.13 Filter Cleaning Tunnel stop automatically after Cleaning process of Filter done.
5.3.14 Removed the filter from Filter trays by Opening the window / door of Filter Cleaning Tunnel and placed on Filter tray of Filter Drying Chamber by Opening the window / door of Filter Drying Chamber.
5.3.15 After Placing the Filter on trays closed the window / door of Filter Drying Chamber.
5.3.16 Switch to ON Button of Filter Drying Chamber from Control Panel.
5.3.17 When temperature of Temperature Controller comes 60ºC then Switch to OFF Button of Filter Drying Chamber from Control Panel.
5.3.18 Removed the filter from Filter trays by Opening the window / door of Filter Cleaning Tunnel.
5.3.19 Check all the filters for any physical damage in housing and media. In case of any damage observed, change
the filter after approval of Engineering Head and record in Annex-V.
5.3.20 Keep the filter into fresh polythene bag & transfer to respective plenum or system.
5.3.21 After completion of filter cleaning closed the compressed air valve & Potable Waterline valve of Filter Cleaning Tunnel.
5.3.22 Clean the Filter Cleaning Machine with cleaned cloth & Filter washing area using fresh water.
5.3.23 Open the inspection window / door / Grill and wipe the filter plenum /Housing / or coil section (whichever is applicable ) by clean duster.
5.3.24 Fix back the filter in the position and Close the system properly to avoid any leakages.
5.3.25 Update the tag fixed on the system with ‘Cleaned on’ date ‘Next due’ date.
5.3.26 Frequency for Pre / Intermediate / Fresh air Filter cleaning :

5.3.27 Record shall be maintained of filter cleaning as per Annex- III.
5.4 PROCEDURE FOR SPARE PRE FILTER REPLACEMENT (Tablet Area) :
5.4.1 Before starting the Pre filter replacement, intimate to user department and QA department.

5.4.2 Ensure that the main switch of the respective AHU is in “OFF” condition.
5.4.3 Keep the Under Maintenance label on the respective equipment which Pre filter to be replaced.
5.4.4 Bring the Spared Cleaned Pre filter from Filters Storage Room in polythene bag.
5.4.5 Open the inspection window / door of filter plenum.
5.4.6 Remove the pre filters from their housing and put it into the polythene bag.
5.4.7 Fix back the Spare Cleaned Pre filter in the position.
5.4.8 Close the inspection window / door of filter plenum or system.
5.4.9 Switch On the AHU.
5.4.10 Update the tag fixed on the system with ‘Cleaned on’ date ‘Next due’ date.
5.4.11 Inform to user department and QA department.
5.4.12 Take the Removed Pre filters to `Filter Washing’ area.
5.4.13 Clean the Filter as per cleaning procedure from “Sr. No. 5.3.7”.

5.6. PROCEDURE OF FILTER REPLACEMENT :
5.6.1 Replacement of filters shall be based on Filter’s Failure ( fails in HEPA filter validation or any physical damage in housing / media weaving disturbed ) Frequency for replacement as mentioned below :

1) PRE and INTERMIDIATE filter:
a) 10 Years – For PRE and INTERMIDIATE filters.
b) If there is abnormal results noted during cleaning of the filters or the above condition which ever is earlier.

2) HEPA Filters / Terminal HVAC Filters:
a) If the differential pressure is continuously not into the specified limit.
b) If there is abnormal results noted during the validation.

3) Unloading side LAF HEPA / Tunnel HEPA filters:
a) If the differential pressure is continuously not into the specified limit.
b) If there is abnormal results noted during the validation.
5.6.2 Replace the filter as per Filter replacement schedule based on above 5.6.1 guidelines and fill the
record in Annex-IV
5.6.3 Individual Filter record shall be filled in Annex-V Filter replacement / Installation record register at
replacement / Installation time.
5.7. PROCEDURE FOR TERMINAL HEPA FILTER REPLACEMENT :
5.7.1.1 Before starting the work ,intimate to user department and QA department after confirmation from all concerned.
5.7.1.2 Ensure that the main switch of the respective AHU is in “OFF” condition.
5.7.1.3 Keep the Under Maintenance label on the respective equipment which filter to be replaced.
5.7.1.4 Close the Supply and return damper of the respective AHU.
5.7.1.5 Before starting the work in area confirm that all equipments, goods/Storage containers/materials are
removed or wrapped.
5.7.1.6 Use the necessary safety equipment before starting the work.
5.7.1.7 Remove the grill of the HEPA filter.
5.7.1.8 Remove the terminal HEPA from its housing.
5.7.1.9 Mark or keep the label of “ Filter to be Disposal” on the respective filter.
5.7.1.10 Clean the HEPA filter housing with the help of wet cloth and dry it by using clean dry cloth.
5.7.1.11 Issue the HEPA filter from the store and take it near respective AHU.
5.7.1.12 Open the packing of the new HEPA filter carefully.
5.7.1.13 Cut the new HEPA filter poly bag and remove the both side thermocol sheet. Fix the HEPA Filter in its respective housing .
5.7.1.14 Check and complete seal all sides of flexible / fixed duct, frame fittings by silicon sealant.
5.7.1.15 Clean the grill and fix it on its respective location.
5.7.1.16 Open the supply / return damper of respective AHU.
5.7.1.17 Inform to QA department to carried out the DOP test as per SOP.
5.8 PROCEDURE FOR LAF /TUNNEL HEPA FILTER REPLACEMENT :
5.8.1.1 Before starting the work , intimate to user department and QA department.
5.8.1.2 Follow gowning procedures as per department .
5.8.1.3 Switch off the main switch of the respective HEPA filter.
5.8.1.4 Keep the Under Maintenance label on the respective equipment.
5.8.1.5 Before starting the work in area, confirm that all equipments, goods/Storage containers/materials are
removed or wrapped.

5.8.1.6 Remove the grill /fixings of the HEPA filter and other attachments of system.
5.8.1.7 Remove all Silicon sealant ; if any
5.8.1.8 Remove the HEPA from its housing
5.8.1.9 Follow the same procedure as Terminal HEPA for fixing it.
5.8.1.10 Seal the sealant after grill /fixing to its outer area.
5.8.1.11 Inform to QA department to carried out the DOP test as per SOP.
5.9. PROCEDURE FOR PRE AND INTERMEDIATE FILTER REPLACEMENT :
5.9.1 Before starting the work ,intimate to user department and QA department.
5.9.2 Ensure that the main switch of the respective AHU / LAF / Tunnels /Dust Collector is in “OFF”
condition.
5.9.3 Keep the Under Maintenance label on the respective equipment which filter to be replaced.
5.9.4 Close the Supply / return damper of the respective System if any.
5.9.5 Open the AHU inspection window/ door or remove the grill /fitments of LAF / Tunnels / Return riser / Dust
collector.
5.9.6 Remove the Pre , Intermediate filters form its housing. Mark or keep the label of “ Filter to be Disposal” on the respective filter.
5.9.7 Mark or Keep the label of “ Filter to be Disposal” on the respective filter.
5.9.8 Clean the filter housing with the help of wet cloth and dry it by using clean dry cloth.
5.9.9 Issue the filter from the store and take it near respective system.
5.9.10 Open the packing of the filter carefully, remove both side thermocol sheet. Fix the Filter in its respective housing .
5.9.11 Check and complete seal all sides of flexible / fixed duct, frame fittings by silicon sealant.
5.9.12 Clean the grill and fix it ; if any. And Close / Fit all enclosures of the systems.
5.9.13 Open the supply / return damper of system ; if any.
5.10. PROCEDURE FOR DISPOSAL OF FILTER :
5.10.1 Take filters labeled as of “Filter to be Disposed” to the scrap yard.
5.10.2 Damage / Scratch the removed filter , media and aluminum frame.
5.10.3 After damage / scratch keep it for scrap in scrap yard.
5.11. HEAP FILTERS VELOCITY MONITORING :
5.11.1 HEPA filters shall be monitored on quarterly basis by checking its ACPH (For Terminal Filters) and Velocity (for LAF Filters). Take the respective room /LAF velocity with the help of Velocity measuring instrument ( Balometer / Anemometer ) for individual supply HEPA for 5 readings. Calculate average velocity / or ACPH as per QA protocol 1QP-HSPQ-01( Vial and Ampoule ) for HEPA validation and Fill the readings in the ACPH / Velocity record .Compare it with previous validated velocity / ACPH from HEPA filter’s validation sheet.

6.0. ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1.0	SOP	Standard Operating Procedure
2.0	EM	Engineering and Maintenance
3.0	QA	Quality Assurance
4.0	DOP	Di-Octa – Thylate
5.0	HEPA	High efficiency particulate air
6.0	AHU	Air Handling Unit
7.0	LAF	Laminar Air Flow

7.0 ATTACHMENTS (ANNEXES) :
Annex I : Details of HVAC / LAF / Other Clean Air Filters
Annex II : HVAC / LAF / Other Clean Air Filters receive and issue register
Annex III: HVAC / LAF / Other Clean Air Filter Cleaning schedule / Record
Annex IV : HVAC / LAF / Other Clean Air Filter replacement schedule
Annex V : Filter replacement / installation records
Annex VI : Recording of air Velocity / ACPH
8.0. REFERENCE :

In House