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