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global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

PARTICLE CONTAMINATION<\/h1>\n

[\/et_pb_text][et_pb_divider color=”gcid-28f18998-2392-4899-ac10-6ddd6c851b9f” divider_weight=”4px” _builder_version=”4.20.0″ _module_preset=”default” width=”100px” global_module=”4392967″ saved_tabs=”all” locked=”off” global_colors_info=”{%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22color%22%93}”][\/et_pb_divider][et_pb_text _builder_version=”4.27.4″ _module_preset=”1f09816e-184e-4ce5-a4cf-b39c52c423ca” text_line_height=”1.4em” custom_margin=”|||60px|false|false” custom_margin_tablet=”|||0px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”on|tablet” hover_enabled=”0″ text_font_size_tablet=”15px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”55px” header_font_size_last_edited=”off|desktop” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

A cleanroom<\/strong> is a chamber within which the concentration of airborne particles is controlled, and
which is constructed and used to minimize the introduction, generation and retention of particles
within it.<\/p>\n

The main reference for controlled contamination environments and their plants is the international standard EN ISO 14644<\/strong>, which consists of 10 parts.<\/p>\n

Classes can be measured in 3 typical occupational conditions:<\/p>\n

    \n
  1. The first occupational condition<\/strong> is that of a newly built cleanroom, as built, functioning but without process equipment and operators inside it (As built).<\/li>\n
  2. The second condition<\/strong> is that of rest (At rest), indicating a cleanroom equipped for the production process with all the equipment in operation but in the absence of production and personnel.<\/li>\n
  3. A cleanroom that is in operating condition, is with the production in progress and the present <\/strong>personnel<\/strong> is indicated with the operating occupational condition or status (Operational).<\/li>\n<\/ol>\n

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    Standards and classes of contamination<\/strong><\/h2>\n

    [\/et_pb_text][et_pb_divider color=”gcid-28f18998-2392-4899-ac10-6ddd6c851b9f” divider_weight=”4px” _builder_version=”4.20.0″ _module_preset=”default” width=”100px” global_module=”4392967″ saved_tabs=”all” locked=”off” global_colors_info=”{%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22color%22%93}”][\/et_pb_divider][et_pb_text _builder_version=”4.27.4″ _module_preset=”1f09816e-184e-4ce5-a4cf-b39c52c423ca” text_line_height=”1.4em” custom_margin=”|||60px|false|false” custom_margin_tablet=”|||0px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”on|tablet” text_font_size_tablet=”15px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”55px” header_font_size_last_edited=”off|desktop” global_colors_info=”{}”]<\/p>\n

    EN ISO 14644-1:2015<\/strong> defines the class by means of an “N” number, which can be the maximum of 9. However, class ISO 9<\/strong> can only be used under operating conditions. Depending on the particle diameter, the maximum allowable particle concentrations (upper limit) are given in the following table.
    It shall indicate the contamination classes with the corresponding particle concentration values.
    Ultimately, the designation of a particle contamination class for EN ISO 14644-1:2015 shall include:
    – the number of classification according to ISO N class;
    – the employment status for which the classification is to be carried out,
    – the diameter of the particle or particles concerned and their concentrations as calculated by the formula given above,
    – if the class is checked for two diameters, the diameter of the largest particle shall be at least 1,5 times larger than the smallest.<\/strong><\/p>\n

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    How to test<\/h2>\n

    [\/et_pb_text][et_pb_divider color=”gcid-28f18998-2392-4899-ac10-6ddd6c851b9f” divider_weight=”4px” _builder_version=”4.20.0″ _module_preset=”default” width=”100px” global_module=”4392967″ saved_tabs=”all” locked=”off” global_colors_info=”{%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22color%22%93}”][\/et_pb_divider][et_pb_text _builder_version=”4.27.4″ _module_preset=”1f09816e-184e-4ce5-a4cf-b39c52c423ca” text_line_height=”1.4em” custom_margin=”|||60px|false|false” custom_margin_tablet=”|||0px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”on|tablet” text_font_size_tablet=”15px” text_font_size_phone=”14px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”55px” header_font_size_last_edited=”off|desktop” global_colors_info=”{}”]<\/p>\n

    The minimum number of points at which concentration measurements are to be made shall be calculated as a function of the cleanroom surface<\/strong>.<\/p>\n

    For statistical consistency with the adopted hypergeometric distribution model, the cleanroom shall be divided into equal sectors and the sampling point shall be representative of each sector<\/strong>.<\/p>\n

    During the sampling phase<\/strong>, the optical particle counter shall be used according to the factory instructions and the probe shall always be placed in the direction of the air flow, if known, otherwise always in the vertical upward position.<\/p>\n

    Contact us to learn more and request our intervention: we will offer you the assistance you need!<\/strong><\/p>\n

    [\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjUwIn19@” button_text=”Contact Us” _builder_version=”4.27.4″ _dynamic_attributes=”button_url” _module_preset=”31b4f027-aaa0-4f2f-ae02-959764e19e4f” custom_button=”on” button_text_size=”14px” button_text_color=”#FFFFFF” button_bg_color=”gcid-1b6a9fe1-de2c-4581-80c9-56ca2c1550aa” button_border_width=”0px” button_border_radius=”0px” button_letter_spacing=”2px” button_font=”Lexend|700||on|||||” button_use_icon=”off” custom_margin=”|||60px|false|false” custom_margin_tablet=”|||0px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”on|tablet” custom_padding=”16px|32px|16px|32px|true|true” saved_tabs=”all” global_colors_info=”{%22gcid-1b6a9fe1-de2c-4581-80c9-56ca2c1550aa%22:%91%22button_bg_color%22%93,%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22button_bg_color__hover%22%93}” button_bg_color__hover_enabled=”on|hover” button_bg_color__hover=”#3ec1f3″ button_bg_enable_color__hover=”on”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.commissioningimpianti.it\/wp-content\/uploads\/2023\/05\/classificazione-locali-farmaceutici.jpg” alt=”classificazione-locali-farmaceutici” title_text=”classificazione-locali-farmaceutici” _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

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