RLAF in dispensing area

If we are changing HEPA filter of RLAF what will be the procedure/ documents for the same?

2 Likes

Because you change HEPA filter hence I think you should re-qualify weighing booth even if re-qualification deadline has not been reached

If you changed the HEPA filter as part of your SOP (i.e, Periodical change for every 2/5 years). Then you can change it followed by the annual qualification.

If the filter changing time line not completed, like filter chocked/damaged not working properly i.e, the differential pressure not within the acceptable range then you have to initiate the deviation and find out the root cause of the occured discrepancy.
Based on the investigation output you have to take CAPA and replace the filter with new one followed by the requalification.