sop for Replacement Policy

1.0 Objective
To lay down a procedure replacement of filters and UV Lights.
2.0 Scope
This Standard Operating Procedure is applicable for the procedure involved in the replacement of filters (i.e. Fresh Air Filter Riser filter, Pre filter, Fine filter, HEPA Filter), and UV Lights of the following Equipment to be followed at formulation plants
Filters

S.No EQUIPMENT NAME Types of filters
1 Air Handling Unit Riser Filters, Fresh Air Filters, Pre Filter, Micro Vee filter, HEPA Filters
2 Ventilation system Pre Filter Micro Vee filter
4 Dust extraction system cartridge filter
5 APUs of Fluid bed dryer Pre Filter, Micro Vee filter, HEPA

6 APUs of Coating Machine Pre Filter, Micro Vee filter, HEPA
7 LAFs and RLAFs Pre Filter, Micro Vee filter, HEPA
8 UV Lights
Water system and its loops, All pass Boxes and Dress Cabinets

3.0 Responsibility
3.1 Officer / Executive Engineering shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No : Number
QA : Quality assurance
ER : Engineering
HEPA : High efficiency Particulate air filter
HVAC : Heating Ventilation and Air Conditioning
UV : Ultra Violet
5.0 Procedure
5.1 Repairing or cleaning of the HEPA filter shall not be carried out.
5.2 Replacement of Fresh Air Filter, Pre Filter Micro Vee filter and cartridge filter will be under following circumstances
5.2.1 Whenever any puncture is observed in the filter element during its inspection, replace the Filter in the respective location with the same specification of filter.
5.2.2 Whenever the filter frame found destructed from its original shape, replace the filter.
5.2.3 Whenever filter elements get permanently chocked due to accumulation of abnormal dust or fiber particles on the filter and that can not be removed by cleaning of filter as per the filter cleaning procedure, then replace the filters.
5.2.4 If the differential pressure of the respective area or Filters are fluctuated from the its Specified limit which may raise doubt regarding the performance of filter then check it visually. If the filter condition found unsatisfactory then replace it.
5.3 Replacement of HEPA Filter.
5.3.1 Whenever HEPA filter integrity test results found not within the limits of the acceptance criteria of HVAC validation Protocol.
5.3.2 Ensure the following points during replacement of filter.
5.3.2.1 During Replacement of HEPA filters due to above said criteria, same shall be replaced with proper change control procedure.
5.3.2.2 The filter replacement to be done when only the respective activity of area or equipment in stop condition.
5.3.2.3 Dispose off the damaged filter, as per SOP No-ER/088-00.of Disposal procedure of engineering waste.
5.3.2.4 Make the necessary entry in filter replacement record.
5.3.2.5 Perform the test of respective filters and areas as SOP for HVAC Validation.
5.3.3 Procedure for UV Lights
5.3.3.1 Removing:
5.3.3.1.1.1 Switch off the mains of UV tube.
5.3.3.1.1.2 Remove UV tube by opening the threaded plug provided at the end of system.
5.3.3.1.2 Slowly pull of the UV tube and disconnect the electrical wires.
5.3.3.1.3 Keep UV tube at the safe area.
5.3.3.2 Fixing:
5.3.3.2.1 Connect the electrical wires to new UV tube.
5.3.3.2.1.1 Slowly insert the UV tube inside the jacket system and direct it to get fixed inside the holder.
5.3.3.2.1.2 Plug the system by closing the thread.
5.3.3.3 Frequency
5.3.3.3.1 Once after 7500 Hrs or when lamp damaged.
6.0 Forms and Records
6.1 Filter Replacement Record – Annexure-1
6.2 Replacement of UV Light – Annexure-2

7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department

sop for Replacement Policy

sop for Execution of Preventive Maintenance

Leave a Comment Cancel reply