There are some sources listed in ISO 14644-3. e.g. PAO、4 cSt, DOS, DEHS, DOP,PSL. However, FDA didnt addresss on it.
For processing HEPA leak test, which’s the most common used in the industry now?
The PSL is suitable for testing as a source of challenge aerosol? Is it concernced that would remain on the filter after testing?
Where can I get supporting informaiton or reference to show my customer if I want to prove that PSL is relaible? The only thing I got is the suggestion that Baxter gave to FDA.
"if the agency feels it is important to include ULPA filters (IEST class F filters) in this document, an alternate challenge using polystyrene latex beads may be more appropriate, especially in environments such as isolators and laminar flow depyrogenation tunnels. It is the manufacturer’s responsibility, however, to demonstrate that the alternative challenge aerosol is suitable. "
[quote=miahsu]There are some sources listed in ISO 14644-3. e.g. PAO、4 cSt, DOS, DEHS, DOP,PSL. However, FDA didnt addresss on it.
For processing HEPA leak test, which’s the most common used in the industry now?
The PSL is suitable for testing as a source of challenge aerosol? Is it concernced that would remain on the filter after testing?
Where can I get supporting informaiton or reference to show my customer if I want to prove that PSL is relaible? The only thing I got is the suggestion that Baxter gave to FDA.
"if the agency feels it is important to include ULPA filters (IEST class F filters) in this document, an alternate challenge using polystyrene latex beads may be more appropriate, especially in environments such as isolators and laminar flow depyrogenation tunnels. It is the manufacturer’s responsibility, however, to demonstrate that the alternative challenge aerosol is suitable. "
Can any one tell us, which is Right Air Velocity Meter (Vane Type /Hot Wire or Analog) to check Air Velocity of Horizontal and Vertical Laminar Air Flow?
