HEPA requirement in ISO 8 / EU 100,000

Is there a stated requirement or guideline for use of HEPA filters in an ISO 8 area? If so, what is the source?

Given the very high allowable particle counts, I know I can meet the requirements without a HEPA, just want to make sure I am not ignoring a requirement.


Yes, ISO class 8 require HEPA in case of recirculated air. You can find this in WHO TRS 937, annex 2, supplementary guidelines for Heating, Ventilation & air condition system for non sterile area (i.e. ISO Class 8)

Can anybody clarify about the latest recovery test procedure during hvac validation as per ISO 14644-3 guideline & also i want to know is there a specific difference in b/w H13 grade HEPA filter & EU 13 grade HEPA filter.

Awaiting your valuable comments.

Sundeep Kulyal
Jagsonpal Pharmaceutical Ltd.

Dear Sundeep,

Below please find link that describe requirment for qualifcation of HVAC. This may help you out for recovery test