CLEAN ROOM TECHNOLOGY
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Clean room classes: |
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Comparison of international standards: The table shows a comparison of different international classification standards. In the pharmaceutical industry and for medical facilities the rooms are mostly classed to GMP. Attached table shows a comparison to the ISO to clean room classes. |
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Filter stages to reach the correct clean room class:
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| 1st and 2nd filter stage:
This is the prefiltering before the HEPA (3rd filter stage)/ULPA (4th filter stage) filter. The mostly used filtertype is the pocket filter. To gain long life time and best Energy-efficiency it is necessary to use an excellent pre-filter. Such as pocket filters product line filtex®durotex, filtex®durotec oder filtex®glass. For teh final pre-filter stage we recommend compact filters filtex®ripac . In case of increased process risk or if there are extremely high air flow rates, for the 2nd filter stage a rigid filter, product line "ripac" should be used instead of pocket filters. |
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3rd and 4th filter layer: Mostly the 3rd filter stage is a HEPA filters of class E10 to H14. (=HEPA filter = High Efficiency Particulate Air filter) The 4th filter stage is an ULPA filter (=Ultra Low Penetration Air filter) of class U15 to U17. HEPA an ULPA filters have a consistently high filtration efficiency from the beginning to the end of life time. The final pressure drop reaches up to 600 Pa. By use of high-quality filtex® filters, the pressure drop and resultant the energy waste can be lowered significantly. The additional effect is a rise in the filter absorbance quality and higher process reliability. |
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Sealing-test-prove: To minimise the process risk, filters and frames can be supplied with option "sealing-test-prove". So, after every filter change, the correct fitting up of the filter into the frame can be tested. |
| Filtertest and Reporting System:
The EN1822 standard must show average and local efficiency a stated air flow rate. It mus also show initial pressure drop and reached filter class. filtex® EPA/HEPA/ULPA filters are subject to highest quality control standards. Single test for each filter.
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Clean Room - validations: To guarantee the clean room class, the rooms must be validated by external specialists periodically. | |












