Qualification of HEPA – filters of sampling and dispensing booths
To lay down a procedure of qualification or re-qualification of HEPA filter of sampling and dispensing booths.
This SOP is applicable for the Qualification of the HEPA filter of the sampling & dispensing booths to check the integrity of the filter, and define the velocity profile and the number of particulars.
Warehouse and Engineering personnel, Quality Control, and Quality Assurance personnel shall be responsible to follow the procedure mentioned in this SOP.
The HEPA filter of sampling and dispensing booths must pass the qualification and requalification Acceptance criteria.
The Qualification will be carried out by the installing agency or external agency.
The HEPA filter passes the qualification concerning the following:
Dioctyl phthalate test (DOP / PAO test ) for filter integrity
The number of particles
The HEPA filter mustn’t have Dioctyl phthalate or PAO leakage and the velocity profile must correspond to the planned standards.
The number of particles must correspond to the planned standards of the class (ISO-5).
Stickers for qualification containing the data about the date of the qualification and re-qualification are affixed to the sampling and dispensing booths. Records of qualification are given by the company doing the qualification. They are filled and documented.
The frequency of Qualification – Once a year.