HEPA tests

The first attempts were to match the AP of a commercial HEPA and evaluate filtration efifieiency. Figure 9 shows the retention and capacity of 0.3 pm NaCl aerosol by 3 plies of such media as compared to a commercially available HEPA. Testing was done by Nelson Laboratories (Salt Lake City, UT). Also shown is the retention of a single ply of the media used as a prefilter for the HEPA. Note that both the 3 plies of HEPA and the combination of a single ply prefilter with HEPA resulted in an ULPA (Ultra low particulate air) filter. 

Depending on the test method and test result, particle filters are classified as coarse, fine, HEPA, and ULPA filters (Table 9.2). Electrofilters are usually included in the fine filter group. Chemical filters are used for gases. 

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 environmental impact of the proposed GATS process appears to be minimal. All handling and processing of agent will be conducted indoors in sealed rooms that are vented through HEPA and carbon filters. Liquid and solid waste streams will be relatively small and manageable and will be subjected to hold-test-release procedures. 

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... 

Air flow velocity (nonunidirectional) test In a nonunidirectional clean room or clean zone, air flow velocity measurements should be made for each terminal HEPA Alter (or supply air diffuser, if applicable) there is no entrance plane as such. 

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 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.). 

The sterility testing area is located in an area of the microbiology laboratory. The area contains a gowning room and sterility testing room. Each testing room contains a unidirectional flow HEPA hood. 

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... 

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