HEPA Filter Validity-HVAC Revalidation

Validation
1

Dear All,

What is the general HEPA Filter Validity period?
i mean what is the shelf life of HEPA Filters after purchasing? upto how long i can store and use.

Thanks

2

If your HEPA filter has not been used and is stored in the original packaging, in a dry climate controlled area and not subjected to extremes in temperature or humidity the shelf life is 10 year.

2 Likes
3

Ok, reference and guidance any!?

4

Appendix c of nuclear air cleaning hand book

5

What is the nessisity of keeping a hepa filter under storage for such a long time?

6

no need to store hepa filter for 10 years. it is research data, how long we can store the hepa filter.The age limit is based on the data derived from the observed decreases in the tensile strength of dry filter media with age.

7

I would suggest the following:

  1. Consult manufacturer for life of the material used to manufacture the HEPA, and if there is any restriction or storage requirements…

  2. When installed and in use, normally, the HEPA filter is replaced when it is clogged (measured thru DP), damaged or leakage repair during certification or any other time is more than 2% of the total area (a thumb rule and may like refer to ISO 14644). If there is no life expectancy stated other than the above for the HEPA filter when in use, why should there be life expectancy when it is in storage.

  3. Sometime, Own Company/business policy may dictate to assign validity for all material in storage. In such case, follow manufacturer’s recommendations or own procedures.

8

Dear All,
What’s the action plan if you extend the HVAC Revalidation of Non sterile area for 2 months

Thanks

9

1.Planned Deviation
2.Risk assessment (If any Product Quality affecting activity is performed there)