- PROCEDURE:
- HEPA stands for High Efficiency Particulate Air. It is a type of air filter that is highly effective at capturing airborne particles. HEPA filters are made of a dense mat of fibers that trap particles as air passes through them.
- Following procedure shall be followed to replace the HEPA filter with new one.
- Switch off the power supply of Air Handling Unit, LAF Units, Dispensing Booth, Isolator, Dynamic pass box and Mist shower or Process Equipment (FBP, Automatic coating equipment and Dust extraction unit) from which HEPA filter is to be replaced with new one.
- Open the service door of the equipment.
- Remove the filter frame fasteners, keep them in a tray, then remove the HEPA filter from the equipment and keep it in a polythene bag for disposal. Polythene bag shall be sealed immediately upon keeping the removed HEPA filter.
- Clean the HEPA filter chamber by using the vacuum cleaner and lint free cloth.
- Open the new HEPA filter from sealed box and observe any physical damage to the HEPA filter face area. (If any damage is observed that HEPA filter shall not be installed).
- Check the new HEPA filter test certificate and ensure that the filter specifications are exactly the same as the specification of filter to be replaced.
- Check the direction of the filter and install the HEPA filter in the relevant chamber carefully and tighten the HEPA filter frame fasteners and apply the food grade silicon sealant at filter fitment area.
- Perform the revalidation tests as per the SOP to ensure that the area is meeting the designed class conditions.
- Record the HEPA Filter replacement activity in the equipment History card.
- The HEPA filter shall be replaced once in every six years from date of installation or if HEPA filter integrity test failure or DP across the HEPA (where ever applicable) is out of limit whichever is earlier.
- However, integrity test shall be performed before replacement of HEPA filter with a new one to ensure the HEPA filter integrity after the last successful revalidation.
- If the HEPA filter fails in the integrity test, the cause of filter failure shall be investigated and the activities happened and products manufactured if any in the area from the date of previous successful integrity test to the current failure date shall be reviewed, tested as applicable and investigated as per SOP.
- REFERENCES:
- Not Applicable
- ANNEXURES:
- Not Applicable
- ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 Head Quality Assurance
- Controlled Copy No. 02 Head-Engineering
- Master Copy Quality Assurance Department
- ABBREVIATIONS:
- HEPA : High Efficiency Particulate Air.
- FBP : Fluid Bed Processor.
- QA : Quality Assurance
- LAF : Laminar Air Flow
- REVISION HISTORY:
- CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To be written manual |