{"id":13290,"date":"2021-03-04T10:15:07","date_gmt":"2021-03-04T09:15:07","guid":{"rendered":"https:\/\/fedegari.com\/?p=13290"},"modified":"2021-04-07T12:44:54","modified_gmt":"2021-04-07T10:44:54","slug":"pda-validation-of-moist-heat-sterilization-processes","status":"publish","type":"post","link":"https:\/\/fedegari.com\/en\/pda-validation-of-moist-heat-sterilization-processes\/","title":{"rendered":"PDA-Validation of Moist Heat Sterilization Processes"},"content":{"rendered":"

[vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” css=”.vc_custom_1614846865233{background-color: #eaedf2 !important;}”][vc_column width=”1\/2″ css=”.vc_custom_1585924107498{margin-top: 30px !important;margin-bottom: 30px !important;padding-top: 30px !important;padding-bottom: 30px !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” offset=”vc_hidden-xs”][vc_single_image image=”13282″ img_size=”full” alignment=”center” style=”vc_box_shadow” css_animation=”fadeIn”][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=”30px”][vc_empty_space height=”15px”][vc_column_text css_animation=”fadeIn”]<\/p>\n

PDA – Validation of Moist Heat Sterilization Processes<\/h1>\n

From 23rd to 25th of March, it will take place in person at Fedegari Facility in Sellerville (PA).[\/vc_column_text][vc_empty_space height=”40px”][vc_btn title=”Register now” style=”classic” shape=”square” color=”success” size=”lg” align=”center” css_animation=”fadeInDown” link=”url:https%3A%2F%2Fwww.pda.org%2Fglobal-event-calendar%2Fevent-detail%2Fpda-468-validation-of-moist-heat-sterilization-processes-2||target:%20_blank|”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row gap=”35″ css=”.vc_custom_1614781794835{margin-top: 60px !important;margin-bottom: 60px !important;}” el_id=”content”][vc_column width=”1\/2″][vc_column_text css_animation=”fadeIn”]<\/p>\n

What will be the topic of PDA training?<\/h1>\n

Based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control, this training course will provide a foundational understanding of sterilization science that can be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. Hands-on activities will include actual sterilization cycle operations and execution with data review. The class will then participate in brainstorming over possible solutions to challenges. If the attendee can bring an example of the load item, it will be integrated into the autoclave execution.* This training course has hands-on lab activities.[\/vc_column_text][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_single_image image=”13310″ img_size=”large”][vc_empty_space height=”20px”][vc_column_text]Moreover, during the training, it will be shown how to calibrate the Kaye equipment applied to Fedegari autoclaves.[\/vc_column_text][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_column_text]<\/p>\n

Learning Objectives<\/h1>\n
    \n
  1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program<\/li>\n
  2. Develop a decision tree to select the most appropriate sterilization process based on the attributes of the load type<\/li>\n
  3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program<\/li>\n
  4. Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous\/hard goods load types<\/li>\n
  5. List the critical elements of process performance qualification<\/li>\n<\/ol>\n

    *PDA courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.[\/vc_column_text][vc_empty_space height=”30px”][vc_btn title=”See the agenda” style=”outline” shape=”square” color=”black” align=”center” css_animation=”fadeInDown” link=”url:https%3A%2F%2Fwww.pda.org%2Fdocs%2Fdefault-source%2Fwebsite-document-library%2Ftraining-courses%2Fagendab0d90ad8a8c4657391feff0000cd242a.pdf%3Fsfvrsn%3De71d6f81_2||target:%20_blank|”][vc_empty_space height=”30px”][\/vc_column][vc_column width=”1\/2″ css=”.vc_custom_1614781814115{margin-top: 1px !important;margin-right: 1px !important;margin-bottom: 1px !important;margin-left: 1px !important;border-top-width: 1px !important;border-bottom-width: 1px !important;padding-top: 15px !important;padding-right: 15px !important;padding-bottom: 15px !important;padding-left: 15px !important;border-top-color: #000000 !important;border-top-style: none !important;border-bottom-color: #000000 !important;border-bottom-style: none !important;border-radius: 1px !important;}”][vc_single_image image=”9482″ img_size=”full” alignment=”center” style=”vc_box_shadow” css_animation=”fadeIn”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_column_text css_animation=”fadeIn”]<\/p>\n

    In which Fedegari subsidiary it will take place?<\/h1>\n

    This training course will take place in person, with a limited number of 8 people, at Fedegari Tech Center USA\u00a0located in Sellersville (PA) within Fedegari Technologies, Inc. facilities.<\/p>\n

    In Fedegari Tech Center USA customers can benefit from technical support, training and R&D personnel expertise on process and cycle development.<\/p>\n

    Fedegari Tech Center USA is equipped with the following process machines for hands-on training and tests:<\/p>\n

    Lab Division:
    \nBINDER incubator<\/p>\n

    Industrial Division:
    \nFCDV – Chemical bio-decontamination unit (hydrogen peroxide)
    \nFOAF – Steam sterilizer \/ Steam-air Sterilizer (moist-heat)
    \nFOWS – Washer-sterilizer
    \nFOW – Super-heated water sterilizer[\/vc_column_text][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_btn title=”Learn more” style=”outline” shape=”square” color=”black” align=”center” css_animation=”fadeInDown” link=”url:https%3A%2F%2Ffedegari.com%2Fen%2Ftech-center%2F|title:Tech%20Center||”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=”60px”][vc_column_text]<\/p>\n

    ONLY 8 SPOTS AVAILABLE!<\/strong><\/span><\/h2>\n

    [\/vc_column_text][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_btn title=”Register now” style=”classic” shape=”square” color=”success” size=”lg” align=”center” css_animation=”fadeInDown” link=”url:https%3A%2F%2Fwww.pda.org%2Fglobal-event-calendar%2Fevent-detail%2Fpda-468-validation-of-moist-heat-sterilization-processes-2||target:%20_blank|”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_empty_space height=”20px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes”][vc_column width=”1\/3″][vc_single_image image=”10980″ img_size=”full” alignment=”center” css_animation=”fadeInUp”][vc_empty_space height=”30px”][vc_column_text css_animation=”fadeInUp”]<\/p>\n

    E-training<\/h3>\n

    Understanding Moist Heat <\/strong>Sterilization and Validation Aspects<\/strong><\/h3>\n

    Principles, Application & Challenges<\/h4>\n

    [\/vc_column_text][vc_empty_space height=”30px”]

    1<\/div>
    Basics of sterilization<\/div><\/div><\/div>\n[vc_empty_space height=”30px”]
    2<\/div>
    Understanding sterility assurance concepts, D-value, Z-value, F0
    \n<\/div><\/div><\/div>\n[vc_empty_space height=”30px”]
    3<\/div>
    How to select the appropriate steam sterilizer according to the load type<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    4<\/div>
    Treatment of porous and liquid loads<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    5<\/div>
    Main factors that strongly impact the outcome of a sterilization process<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    6<\/div>
    Selecting the validation methodologies according to load attributes: overkill, bioburden\/biological indicator and bioburden-based approach<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    7<\/div>
    Defining the \u201cworst case\u201d load<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    8<\/div>
    Performing physical and microbiological studies<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    9<\/div>
    Validation equipment (TC\u2019s, CI\u2019s, BI\u2019s): selection, placement and results interpretation<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”][vc_btn title=”Contact Fedegari” style=”outline” shape=”square” color=”black” align=”center” button_block=”true” link=”url:https%3A%2F%2Ffedegari.com%2Fen%2Fcontact-us%2F|||”][vc_empty_space height=”30px”][vc_empty_space height=”30px”][\/vc_column][vc_column width=”1\/3″][vc_single_image image=”1659″ img_size=”full” alignment=”center” css_animation=”fadeInUp”][vc_empty_space height=”30px”][vc_column_text css_animation=”fadeInUp”]<\/p>\n

    E-training<\/h3>\n

    Insights in Chemical <\/b>Bio-Decontamination<\/b><\/h3>\n

    Design, Application & Validation of H2O2 Processes<\/h4>\n

    [\/vc_column_text][vc_empty_space height=”30px”]

    1<\/div>
    Overview of vaporized hydrogen peroxide technology
    \n<\/div><\/div><\/div>\n[vc_empty_space height=”30px”]
    2<\/div>
    Critical process parameters and examples of relevant case studies<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    3<\/div>
    Validation activities: enclosure evaluation and CI\u2019s, BI\u2019s and TC\u2019s utilization<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”][vc_btn title=”Contact Fedegari” style=”outline” shape=”square” color=”black” align=”center” button_block=”true” link=”url:https%3A%2F%2Ffedegari.com%2Fen%2Fcontact-us%2F|||”][vc_empty_space height=”30px”][vc_empty_space height=”30px”][\/vc_column][vc_column width=”1\/3″][vc_single_image image=”1497″ img_size=”full” alignment=”center” css_animation=”fadeInUp”][vc_column_text css_animation=”fadeInUp”]<\/p>\n

    E-training<\/h3>\n

    Overcoming Challenges in a Sterility Testing Isolator<\/b><\/h3>\n

    Testing Procedures and Environmental Monitorin<\/h4>\n

    [\/vc_column_text][vc_empty_space height=”30px”]

    1<\/div>
    Guidance on conducting sterility testing and environmental monitoring
    \n<\/div><\/div><\/div>\n[vc_empty_space height=”30px”]
    2<\/div>
    Practical advice on consumables, equipment, design, application and challenges<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”]

    3<\/div>
    Achievieng the highest level of safety and testing confidence<\/p>\n

    <\/div><\/div><\/div>\n[vc_empty_space height=”30px”][vc_btn title=”Contact Fedegari” style=”outline” shape=”square” color=”black” align=”center” button_block=”true” link=”url:https%3A%2F%2Ffedegari.com%2Fen%2Fcontact-us%2F|||”][vc_empty_space height=”30px”][vc_empty_space height=”30px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes”][vc_column][vc_cta h2=”Do you need more information?” h2_font_container=”color:%230a0a0a” h2_google_fonts=”font_family:Ubuntu%3A300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic|font_style:500%20bold%20regular%3A500%3Anormal” h4=”Contact us to create your own program. We can deliver you a unique learning experience.” txt_align=”center” style=”flat” add_button=”bottom” btn_title=”Contact our team today!” btn_style=”outline” btn_shape=”square” btn_color=”black” btn_size=”lg” btn_align=”center” add_icon=”bottom” i_icon_fontawesome=”fa fa-graduation-cap” i_color=”black” i_css_animation=”fadeIn” css_animation=”flipInX” use_custom_fonts_h2=”true” btn_link=”url:https%3A%2F%2Ffedegari.com%2Fen%2Fcontact-us%2F|title:Contact%20Us|target:%20_blank|”]Request your customized training offer to acquire deeper knowledge about specific subjects.<\/p>\n

    We will cover the science behind the processes and practical advice to guarantee the highest performances to your team.[\/vc_cta][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” css=”.vc_custom_1551450117939{background-color: #eaedf2 !important;}”][vc_column][vc_row_inner][vc_column_inner][vc_empty_space height=”20px”][\/vc_column_inner][\/vc_row_inner][vc_row_inner css=”.vc_custom_1553013553079{background-color: #c4161c !important;}”][vc_column_inner][vc_empty_space height=”20px”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

    PDA \u2013 Validation of Moist Heat Sterilization Processes.
    \nFrom 23rd to 25th of March, it will take place in person at Fedegari Facility in Sellerville (PA)<\/p>\n","protected":false},"author":14,"featured_media":13282,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[153],"tags":[],"class_list":["post-13290","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"yoast_head":"\nPDA-Validation of Moist Heat Sterilization Processes - Fedegari - Innovative solutions for clean and sterile processes<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fedegari.com\/en\/pda-validation-of-moist-heat-sterilization-processes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PDA-Validation of Moist Heat Sterilization Processes - Fedegari - Innovative solutions for clean and sterile processes\" \/>\n<meta property=\"og:description\" content=\"PDA \u2013 Validation of Moist Heat Sterilization Processes. 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