[fusion_builder_container admin_label=”” hundred_percent=”no” equal_height_columns=”yes” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”#f8f8f8″ background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”120px” padding_right=”” padding_bottom=”120px” padding_left=””][fusion_builder_row][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”60px” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Nosso trabalho

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A atuação é orientada pela responsabilidade e a prestação de serviços de certificação em:

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Áreas limpas

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Capela de fluxo laminar unidirecional (horizontal e vertical)

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Capela de exaustão

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UV’S (Unidades de ventilação)

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Ar comprimido

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Nitrogênio

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Capela de fluxo de biossegurança

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Entre outras

[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”7px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” bottom_margin=”20px” alignment=”center” /][fusion_button link=”https://globalcertifica.com.br/blog/” text_transform=”” title=”” target=”_self” link_attributes=”” alignment=”” modal=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” color=”default” button_gradient_top_color=”” button_gradient_bottom_color=”” button_gradient_top_color_hover=”” button_gradient_bottom_color_hover=”” accent_color=”” accent_hover_color=”” type=”” bevel_color=”” border_width=”” size=”” stretch=”default” shape=”” icon=”” icon_position=”left” icon_divider=”no” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Últimas Novidades[/fusion_button][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”0px” padding_right=”0px” padding_bottom=”0px” padding_left=”8%” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_imageframe image_id=”303″ style_type=”none” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” alt=”” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://globalcertifica.com.br/wp-content/uploads/2016/11/research_big_icon.png[/fusion_imageframe][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” border_style=”solid” padding_top=”0″ padding_bottom=”0″][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_section_separator divider_type=”triangle” divider_position=”center” divider_candy=”bottom” bordersize=”1″ bordercolor=”#f8f8f8″ backgroundcolor=”#f8f8f8″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility” /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”” hundred_percent=”no” equal_height_columns=”yes” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”rgba(248,248,248,0)” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”120px” padding_right=”” padding_bottom=”120px” padding_left=””][fusion_builder_row][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”60px” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_imageframe image_id=”286″ style_type=”none” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” alt=”” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://globalcertifica.com.br/wp-content/uploads/2016/11/discover_big_icon.png[/fusion_imageframe][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Sala / Área Limpa (Clean Room)

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“Sala na qual a concentração de partículas em suspensão no ar é controlada; é construída e utilizada de maneira a minimizar a introdução, geração e retenção de partículas dentro da sala, na qual outros parâmetros relevantes, como, por exemplo, temperatura, umidade e pressão, são controlados conforme necessário.” (ABNT NBR ISO 14644-1).

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Ensaios e serviços prestados em áreas limpas;

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Medição da saturação dos Pré-filtros;

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Medição da saturação dos Filtros Absolutos;

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Ensaio de integridade dos filtros HEPA / ULPA;

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Contagem eletrônica de partículas suspensas no ar (Classificação);

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Medição De Vazão de ar e Cálculo do Número de Trocas de ar por hora;

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Medição do diferencial de pressão entre salas;

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Medição de temperatura e umidade relativa do ar;

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Medição de Luminosidade;

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Medição de Ruído;

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Ensaios opcionais;

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Ensaio de recuperação do ambiente

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Qualificação de instalação (QI);

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Qualificação de Operação (QO);

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Teste de fumaça com ou sem filmagem;

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EQUIPAMENTO DE FLUXO LAMINAR VERTICAL/ HORIZONTAL

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“Equipamento autônomo de fluxo de ar limpo que atende aos requisitos de velocidade e uniformidade de fluxo de ar especificados nesta norma ISO-14644. Embora atualmente entendido como não apropriado, o termo comercial “fluxo laminar” é usualmente utilizado para definir esse tipo de equipamento.” (ABNT NBR 15767:2009).

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Medição da saturação (pressão em mmca) dos Filtros HEPA / ULPA;

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Ensaio de integridade dos filtros HEPA / ULPA;

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Contagem eletrônica de partículas ar (Classificação);

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Medição de Velocidade do ar;

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Medição de temperatura e umidade relativa do ar;

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Medição de luminosidade;

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Medição de ruído;

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Medição do índice de saturação dos filtros HEPA;

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Ensaio de Fumaça;

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Ensaio de Linearidade – Paralelismo.

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Ensaios Opcionais:

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Qualificação de instalação (QI);

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Qualificação de Operação (QO);

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Medição da radiação UV (Lâmpada Germicida).

[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” bottom_margin=”20px” alignment=”center” /][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” bottom_margin=”20px” alignment=”center” /][fusion_global id=”758″][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”0px” padding_right=”0px” padding_bottom=”0px” padding_left=”8%” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_imageframe image_id=”281″ style_type=”none” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” alt=”” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://globalcertifica.com.br/wp-content/uploads/2016/11/analysis_big_icon.png[/fusion_imageframe][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” border_style=”solid” padding_top=”0″ padding_bottom=”0″][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_section_separator divider_type=”triangle” divider_position=”center” divider_candy=”bottom” bordersize=”1″ bordercolor=”#f8f8f8″ backgroundcolor=”#f8f8f8″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility” /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”” hundred_percent=”no” equal_height_columns=”yes” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”120px” padding_right=”” padding_bottom=”120px” padding_left=”” admin_toggled=”yes”][fusion_builder_row][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”60px” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_imageframe image_id=”311″ style_type=”none” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” alt=”” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://globalcertifica.com.br/wp-content/uploads/2016/11/testing_big_icon.png[/fusion_imageframe][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Certificação de Cabines de Segurança Biológica

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As Cabines de Segurança Biológica, tem como objetivo proteger o operador, o meio ambiente e as amostras manipuladas. Há vários níveis de Cabines que dependem do grau de segurança necessário e nível de periculosidade dos agentes biológicos envolvidos nas atividades. NSF/ANSI-2008

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Medição da saturação (pressão em mmca) dos Filtros HEPA / ULPA;

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Ensaio de integridade dos filtros HEPA / ULPA;

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Contagem eletrônicas de partículas ar (Classificação);

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Medição de Velocidade do ar;

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Medição de temperatura e umidade relativa do ar;

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Medição de luminosidade;

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Medição de ruído;

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Medição do índice de saturação dos filtros HEPA;

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Ensaio de Fumaça;

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Ensaio de Linearidade – Paralelismo.

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Ensaios Opcionais:

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Qualificação de instalação (QI);

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Qualificação de Operação (QO);

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Medição da radiação UV (Lâmpada Germicida).

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Certificação de Sistema de Tratamento de Distribuição de Ar Comprimido

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Para assegurar a operação eficiente e confiável do compressor o sistema de tratamento e distribuição de ar comprimido deve ser certificado.
Os principais pontos de contaminação no ar comprimido são o óleo, a umidade e particulados.

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Ensaios padrões:

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Contagem Eletrônica de Partículas;

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Teor de Água;

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Teor de Oxigênio;

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Residual de óleo;

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Teor Dióxido de Carbono;

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Teor Monóxido de Carbono;

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Teor de Dióxido de Nitrogênio;

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Teor de Monóxido de Nitrogênio;

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Teor de Gás Sulfídrico;

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Teor de Enxofre;

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Teor de Hidrocarboneto;

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Teor de Trietanolamina;

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Ensaios de partículas viáveis TSA, Sabouraund;

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Ensaios Opcionais:

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Qualificação de instalação (QI);

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Qualificação de Operação (QO).

[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”7px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” bottom_margin=”20px” alignment=”center” /][fusion_global id=”758″][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”60px” animation_type=”” 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border_style=”solid” padding_top=”0″ padding_bottom=”0″ admin_toggled=”no”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_section_separator divider_type=”triangle” divider_position=”center” divider_candy=”bottom” bordersize=”1″ bordercolor=”#f8f8f8″ backgroundcolor=”#f8f8f8″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility” /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”” hundred_percent=”no” equal_height_columns=”yes” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”120px” padding_right=”” padding_bottom=”120px” padding_left=”” admin_toggled=”no”][fusion_builder_row][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”60px” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_imageframe image_id=”311″ style_type=”none” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” alt=”” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://globalcertifica.com.br/wp-content/uploads/2016/11/testing_big_icon.png[/fusion_imageframe][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”yes” hover_type=”none” link=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

Certificação de Sistema de Tratamento de Distribuição de Nitrogênio

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O Nitrogênio obtido através de geradores ou de cilindros também devem ser certificados.

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Ensaios padrões:

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Contagem Eletrônica de Partículas;

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Teor de Água;

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Teor de Oxigênio;

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Residual de óleo;

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Teor Dióxido de Carbono;

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Teor Monóxido de Carbono;

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Teor de Dióxido de Nitrogênio;

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Teor de Monóxido de Nitrogênio;

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Teor de Gás Sulfídrico;

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Teor de Enxofre;

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Teor de Hidrocarboneto;

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Teor de Trietanolamina;

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Ensaios de partículas viáveis TSA, Sabouraund;

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Ensaios Opcionais:

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Qualificação de instalação (QI);

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Qualificação de Operação (QO).

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Serviços de Qualificação de Instalação, Operação e Desempenho

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A Global Certificação e Validação oferece os serviços de Qualificação de Instalação, Operação e Desempenho para equipamentos em geral, como: Compressoras, misturadores, envasadoras, encartuchadeiras, enblistadeira, revestidoras, capelas, hi shear, reatores, leito fluidizado, dentre outros. E também utilidades, como: HVAC, obtenção de tratamento e distribuição de ar comprimido, tratamento de água PW/WFI, instalações de vapor e rede de nitrogênio.

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Qualificação de Instalação (QI):
Conjunto de operações realizadas para assegurar que as instalações, tais como: equipamentos, infraestrutura, instrumentos de medição,
utilidades e áreas de fabricação, utilizadas nos processos produtivos e ou em sistemas computadorizados, estão selecionados e apropriadamente e corretamente instalados de acordo com as especificações estabelecidas. A qualificação de instalação fornece evidências documentadas de que a instalação foi finalizada de forma satisfatória.

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Qualificação de Operação (QO):
Conjunto de operações que estabelecem sob condições especificadas, que o sistema ou subsistema operam conforme previsto, em todas as faixas operacionais consideradas. Todos os equipamentos utilizados na execução dos ensaios devem ser identificados e calibrados antes de serem usados. A qualificação operacional fornece evidências documentadas de que as utilidades, sistemas ou equipamentos e todos os seus componentes operam de acordo com as especificações operacionais.

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Qualificação de Desempenho (QD):
Verificação documentada que o equipamento ou sistema apresenta desempenho consistente e reprodutível, de acordo com parâmetros e especificações definidas, por períodos prolongados.  A qualificação de desempenho fornece evidências documentadas de que as utilidades, sistemas ou equipamentos e todos os seus componentes demonstrem desempenho consistente de acordo com as especificações de uso em rotina.

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