HEPA filter testing

HEPA filter integrity testing is performed at 6-month intervals on level I and level II HEPA filters. HEPA filter testing includes Measuring (Machines, Eilters, Diffusers) Inlet and Outlet Air Velocity or Volume and Integrity Test of HEPA Filters Using Aerosol and Photometer. Refer to (provide reference to attachment no.). 

HEPA and ULPA filters have been developed. In the CEN EN 1822 1998 test method, the filter s efficiency is determined for the most penetrating particle size (MPPS). Depending on the filter s total level of separation and leakage, the filter is classified as HIO, Hll,.. ., H14 and U15, U16, or U17. HEPA filters are commonly used for inlet air in the pharmaceutical, optical, and food industries. 

In order to maintain a high level of air qualit), it is necessary to test airflow velocities and HEPA filters for integrity. These tests are described in a variety of standards and recommended practices depending on the use of the airflow bench. 

HEPA filters consist of a filter pack sealed into a case. The filter pack or core is made by pleating a continuous web of fiberglass paper back and forth over corrugated separators. The filter pack is sealed into a full-depth wood or steel casing using a elastomeric sealant. Gasketing is a critical item to ensure that the filter passes the air leakage tests. 

Sodium flame test A test of HEPA filter efficiency using small particles generated from NaCl. 

Efficiency testing of high-efficiency partieulate air (HEPA) filters used for the supply of sterile air to aseptie workplaces (Chapter 22) is normally achieved by the generation upstream of dioetylphthalate (DOP) or sodium ehloride particles of known dimension, followed by deteetion in downstream filtered air. Retention efficiency is reeorded as the percentage of partieles removed under defined test conditions. Microbiological tests are not normally performed. 

The recommended air velocity of a HEPA filter is 0.45 m/s. The HEPA filter and its housing must be tested mounted on site with the DOP. Eor return openings for powder production, the housing with HEPA filter must be fitted with a prefilter removable from the front. The recommendation is to use HEPA filter presealed in the housing located in a stainless steel frame. 

Measurements in Unmanned Condition 1.1 Integrity testing of HEPA filters... 

These tests are performed after the HEPA filter leak tests and air velocity tests are completed. 

Level I. Areas classified as class 100, critical areas, involve operations in which the sterilized product containers and closures are exposed to the environment. The most stringent quality standards are imposed upon areas directly over the filling/closing operation (in the filling suite). Curtains or shroud borders are attached to the perimeter of the HEPA filter housing to maintain the air quality of the critical area. This type of area includes the aseptic filling suites and the sterility test LAFH. The areas classified as level I are as follows ... 

HEPA filter evaluation (airborne particulate levels, smoke-challenge testing, velocity measurements, etc.)... 

DOP test records of HEPA filters and revalidation records... 

The purpose is to check the integrity for HEPA filters by leak test to assure that they are not damaged during installation or operation. 

HEPA FILTER LEAK (DOP) TEST RESULTS Company Name... 

Adjustments in the air source should be made to obtain a controlled flow of air within the tunnel and across the entrance and exit openings. Air must be particulate-free as it enters the tunnel area therefore, all high efficiency particulate air (HEPA) filters in the tunnel must be integrity tested and certified prior to validation studies. 

Filter integrity, including HEPA filter leak test... 

Additional needed process equipment was evaluated, selected, purchased, and set up. Automation opportunities were defined, and process control instruments were tested, purchased, and installed. An existing clean (HEPA-filtered) area was upgraded for the final isolation of the dilevalol hydrochloride made in New lersey—this was needed to serve the requirements for the parenteral dosage form. 

Refinement of HEPA filter manufacturing and testing technology and development of the ultra low particulate air (ULPA) filter, have led to an increase of absolute filtration retention efficiency of greater than two orders of magnitude above 99.97%. HEPA filtration efficiencies range from a minimum of 99.97 to 99.99%, with ULPA efficiencies above 99.9999%o for particulates larger and smaller than 0.3 pm in diameter... 

Individual HEPA filter efficiencies are established by an exacting challenge of the filter frame and medium, usually incorporating a cold-boil, polydisperse aerosol of dioctylpthalate (DOP) or equivalent, which is introduced into the upstream plenum-side of the filter in a manner that ensures even distribution of the test aerosol behind the filter, at its rated airflow. 

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