{"id":10276,"date":"2025-04-25T21:22:54","date_gmt":"2025-04-25T19:22:54","guid":{"rendered":"https:\/\/litek-pharma.com\/fabricacion-de-aisladores-farmaceuticos-la-creacion-del-mock-up\/"},"modified":"2026-05-22T08:51:29","modified_gmt":"2026-05-22T06:51:29","slug":"fabricacion-de-aisladores-farmaceuticos-la-creacion-del-mock-up","status":"publish","type":"post","link":"https:\/\/litek-pharma.com\/en\/fabricacion-de-aisladores-farmaceuticos-la-creacion-del-mock-up\/","title":{"rendered":"Pharmaceutical Isolator Manufacturing: Creating the Mock-Up"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10276\" class=\"elementor elementor-10276 elementor-9307\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a252944 e-flex e-con-boxed wcf-starter-animations-none e-con e-parent\" data-id=\"a252944\" data-element_type=\"container\" data-e-type=\"container\" 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data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;,&quot;wcf_enable_pin_area&quot;:&quot;no&quot;,&quot;aae_enable_header_sticky_area&quot;:&quot;no&quot;,&quot;wcf_enable_horizontal_scroll&quot;:&quot;no&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"aae-disable-transition elementor-element elementor-element-f2450e4 e-con-full animated-slow e-flex wcf-starter-animations-none elementor-invisible e-con e-child\" data-id=\"f2450e4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_enable_pin_area&quot;:&quot;yes&quot;,&quot;wcf_pin_area_end&quot;:&quot;bottom 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<span class=\"info-s-title\"> Linkedin <\/span>\r\n\t\t\t\t\t                        <span>\r\n                                                                                            <\/span>\r\n\t\t\t\t\t\t\t\t\t\t                    <\/a>\r\n                <\/li>\r\n\t\t\t        <\/ul>\r\n\t\t\r\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9fa2d7e e-con-full e-flex wcf-starter-animations-none e-con e-child\" data-id=\"9fa2d7e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;,&quot;wcf_enable_pin_area&quot;:&quot;no&quot;,&quot;aae_enable_header_sticky_area&quot;:&quot;no&quot;,&quot;wcf_enable_horizontal_scroll&quot;:&quot;no&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8a9c1ba e-con-full e-flex wcf-starter-animations-none e-con e-child\" data-id=\"8a9c1ba\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;,&quot;wcf_enable_pin_area&quot;:&quot;no&quot;,&quot;aae_enable_header_sticky_area&quot;:&quot;no&quot;,&quot;wcf_enable_horizontal_scroll&quot;:&quot;no&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-d1735d8 e-con-full e-flex wcf-starter-animations-none e-con e-child\" data-id=\"d1735d8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;,&quot;wcf_enable_pin_area&quot;:&quot;no&quot;,&quot;aae_enable_header_sticky_area&quot;:&quot;no&quot;,&quot;wcf_enable_horizontal_scroll&quot;:&quot;no&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-2b89a0e e-flex e-con-boxed wcf-starter-animations-none e-con e-child\" data-id=\"2b89a0e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;,&quot;wcf_enable_pin_area&quot;:&quot;no&quot;,&quot;aae_enable_header_sticky_area&quot;:&quot;no&quot;,&quot;wcf_enable_horizontal_scroll&quot;:&quot;no&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b04cb26 elementor-widget-mobile_extra__width-inherit wcf-starter-animations-none wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"b04cb26\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_starter_animations&quot;:&quot;none&quot;,&quot;wcf_anim_duration&quot;:1000,&quot;wcf_anim_delay&quot;:0,&quot;wcf_anim_ease&quot;:&quot;ease&quot;,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;aae_method&quot;:&quot;from&quot;,&quot;aae_trigger&quot;:&quot;on_scroll&quot;,&quot;delay&quot;:0.14999999999999999,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In the manufacturing of pharmaceutical isolators, pre-assembly validation is not a secondary step but a critical phase in the equipment\u2019s lifecycle. At\u00a0<a href=\"https:\/\/litek-pharma.com\/en\/\">LITEK Pharma<\/a>, as specialized manufacturers of containment and aseptic processing solutions, we know that effective design is not just about blueprints, it\u2019s about adapting to the operator\u2019s real-world environment.<\/p><p>That\u2019s why we systematically implement the creation of full-scale (1:1) physical mock-ups. This functional model, built in wood, allows early validation of key aspects such as ergonomics, accessibility, visibility, and process logic. The goal is not just to verify the design but to anticipate deviations, mitigate risks, and ensure that each isolator is ready to operate under real conditions from day one.<\/p><h2><b>What Is an Isolator Mock-Up?<\/b><\/h2><p>A mock-up is a three-dimensional replica of the final isolator, built to exact dimensions using easily modifiable materials to allow on-site adjustments. At LITEK, we construct it in high-density wood, respecting all critical design measurements approved by the client.<\/p><p>Its main purpose is to serve as a validation platform for engineering, quality, and operations teams to:<\/p><ul><li aria-level=\"1\">Simulate real tasks to be performed inside the isolator<\/li><li aria-level=\"1\">Validate operator reach to key areas<\/li><li aria-level=\"1\">Detect physical barriers, interferences, or blind spots<\/li><li aria-level=\"1\">Verify cleaning and disinfection feasibility under GMP regulations<\/li><li aria-level=\"1\">Assess the physical effort required for repetitive or delicate tasks<\/li><\/ul><p>Ultimately, it\u2019s an applied engineering tool that enables corrections, improvements, or adaptations before the isolator enters the manufacturing phase.<\/p><h3>\u00a0<\/h3><h3><b>1. Initial Design Validated by the Client<\/b><\/h3><p>The process starts with a detailed digital design developed in a CAD environment, which takes into account the client\u2019s technical requirements (URS), process specifications, and applicable regulatory standards (ISO 14644, EU GMP Annex 1, etc.).<\/p><p>This initial design is reviewed jointly with the client\u2019s technical team. Once conceptually validated, it becomes the basis for the mock-up fabrication.<\/p><p>This stage allows early detection of inconsistencies in process flow, redundancies, or poorly utilized areas, before proceeding with final model production.<\/p><h3><b>2. Mock-Up Fabrication<\/b><\/h3><p>At LITEK, we build the mock-up in-house with a high level of dimensional accuracy. Each mock-up includes all configurable elements of the isolator:<\/p><ul><li aria-level=\"1\">Glove ports and transfer ports<\/li><li aria-level=\"1\">RTPs and transfer airlocks<\/li><li aria-level=\"1\">Internal trays, shelving, and worktables<\/li><li aria-level=\"1\">Simulated lighting, electrical and pneumatic outlets<\/li><li aria-level=\"1\">Cleaning systems (spray balls, WIP\/SIP nozzles)<\/li><\/ul><p>This replica allows us to evaluate the functional layout of each component and test their interaction with the operator. It also offers the flexibility to make immediate adjustments if deviations are detected during validation.<\/p><h3><b>3. Active Involvement of the End User<\/b><\/h3><p>A key part of this process is the direct involvement of the client\u2019s operating team. During the mock-up validation sessions, the personnel who will use the isolator, whether from production, quality control, or maintenance, interact with the setup to simulate actual tasks.<\/p><p>This involvement allows for:<\/p><ul><li aria-level=\"1\">Detecting ergonomic limitations based on user anthropometrics<\/li><li aria-level=\"1\">Validating the workflow sequence as it will be performed in the facility.<\/li><\/ul><h3><b>4. Full Process Simulation<\/b><\/h3><p>Once the mock-up is built, we ask the client to provide materials equivalent or representative of their real process (containers, tools, raw materials, instruments).<\/p><p>If such items are not available, our team can produce wooden or plastic replicas to ensure the simulation is as realistic as possible.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d197ebd wcf-starter-animations-none elementor-widget elementor-widget-wcf--image\" data-id=\"d197ebd\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;wcf_starter_animations&quot;:&quot;none&quot;,&quot;wcf_anim_duration&quot;:1000,&quot;wcf_anim_delay&quot;:0,&quot;wcf_anim_ease&quot;:&quot;ease&quot;,&quot;wcf-image-animation&quot;:&quot;none&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"wcf--image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"wcf--image\">\r\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/litek-pharma.com\/wp-content\/uploads\/2026\/03\/fabricacion-aisladores-dest.webp\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8b7ff7 elementor-widget-mobile_extra__width-inherit wcf-starter-animations-none wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"a8b7ff7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_starter_animations&quot;:&quot;none&quot;,&quot;wcf_anim_duration&quot;:1000,&quot;wcf_anim_delay&quot;:0,&quot;wcf_anim_ease&quot;:&quot;ease&quot;,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;aae_method&quot;:&quot;from&quot;,&quot;aae_trigger&quot;:&quot;on_scroll&quot;,&quot;delay&quot;:0.14999999999999999,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>This step enables:<\/p><ul><li aria-level=\"1\">Reproducing actual workflows for loading and unloading<\/li><li aria-level=\"1\">Validating material flow and operational logic<\/li><li aria-level=\"1\">Measuring intervention times and ergonomic stress points<\/li><li aria-level=\"1\">Identifying critical areas for cleaning or maintenance<\/li><\/ul><h3><b>5. Application of the EER Protocol (Ergonomic and Risk Study)<\/b><\/h3><p>During the mock-up phase, we apply an internal technical protocol called\u00a0<a href=\"https:\/\/w3.ual.es\/GruposInv\/Prevencion\/evaluacion\/procedimiento\/descargacompleta.pdf?utm_source=chatgpt.com\">EER<\/a>\u00a0(Ergonomic and Risk Study), which includes:<\/p><ul><li aria-level=\"1\">Dimensional verification of each component<\/li><li aria-level=\"1\">Assessment of the accessibility of gloves, trays, and services<br \/>Step-by-step simulation of each task in the process<\/li><li aria-level=\"1\">Identification of ergonomic, microbiological, or mechanical risks<\/li><li aria-level=\"1\">Photographic documentation, measurements, and technical notes<\/li><li aria-level=\"1\">Documented modification proposals<br \/><br \/><\/li><\/ul><p>This report is then reviewed by Engineering, Production, Quality, and Project Management departments before proceeding to the final manufacturing stage.<\/p><h3><b>6. Issue Resolution and Design Improvement<\/b><\/h3><p>If any interferences, poor access, or ergonomic risks are detected during validation, the LITEK technical team proposes solutions that meet the following criteria:<\/p><ul><li aria-level=\"1\">Ergonomic adjustment without compromising process safety<\/li><li aria-level=\"1\">Compliance with GMP guidelines and hygienic design principles<\/li><li aria-level=\"1\">Minimal impact on the isolator\u2019s overall architecture<\/li><li aria-level=\"1\">Direct implementation in the manufacturing phase<br \/><br \/><\/li><\/ul><p>These decisions are discussed and validated with the client in real time, allowing the project to move forward without delays or unnecessary rework.<\/p><h3><b>7. Mock-Up Duration and Key Objectives<\/b><\/h3><p>The mock-up process typically takes place at our facilities over 2 to 3 business days, depending on the complexity of the equipment and the number of users involved in the validation.<\/p><p>The main objectives of this phase are:<\/p><ul><li aria-level=\"1\">Confirming the technical design in a simulated environment<\/li><li aria-level=\"1\">Detecting and correcting errors before manufacturing<\/li><li aria-level=\"1\">Reducing risks during\u00a0<a href=\"https:\/\/www.incibe.es\/incibe-cert\/blog\/pruebas-fat-y-sat-dispositivos-industriales\">Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)<\/a><\/li><li aria-level=\"1\">Improving the end user\u2019s operational experience<\/li><li aria-level=\"1\">Shortening the plant commissioning timeline<\/li><li aria-level=\"1\">Building user confidence in operating the isolator<\/li><\/ul><h3><b>8. Option to Purchase the Mock-Up for Training Purposes<\/b><\/h3><p>The isolator mock-up is a highly valuable training tool, offering a physical and functional representation of the isolator. For this reason, the possibility of purchasing the mock-up is considered so clients can keep it on-site for training their operators and building confidence in isolator use.<\/p><h2><b>Pharmaceutical Isolator Manufacturing: Precision, Ergonomics, and Validation<\/b><\/h2><p>At LITEK Pharma, we understand that an isolator is not just a physical barrier but a critical process system that must meet functional, regulatory, and operator-specific requirements. The creation of the mock-up is the tool that allows us to align these three pillars from the initial design phase.<\/p><p>Based on our project experience, this stage helps anticipate most of the deviations typically encountered during installation, facilitating more efficient manufacturing and stronger alignment between design and real-world use.<br \/><br \/><\/p><p><b>Looking to ensure ergonomics and efficiency in your next project?\u00a0<\/b><a href=\"https:\/\/litek-pharma.com\/en\/contact\/\">Get in touch<\/a>\u00a0with our technical team, we\u2019ll help you validate it step by step.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f41027e e-con-full e-flex wcf-starter-animations-none e-con e-child\" data-id=\"f41027e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;,&quot;wcf_enable_pin_area&quot;:&quot;no&quot;,&quot;aae_enable_header_sticky_area&quot;:&quot;no&quot;,&quot;wcf_enable_horizontal_scroll&quot;:&quot;no&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0d065d0 wcf-starter-animations-none wcf-t-animation-none elementor-widget elementor-widget-heading\" data-id=\"0d065d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;wcf_starter_animations&quot;:&quot;none&quot;,&quot;wcf_anim_duration&quot;:1000,&quot;wcf_anim_delay&quot;:0,&quot;wcf_anim_ease&quot;:&quot;ease&quot;,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Tags:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2830e5 elementor-widget elementor-widget-wcf--blog--post--tags\" data-id=\"d2830e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;aae_method&quot;:&quot;from&quot;,&quot;aae_trigger&quot;:&quot;on_scroll&quot;,&quot;delay&quot;:0.14999999999999999,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"wcf--blog--post--tags.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t        <div class=\"wcf--post-tags\">\r\n\t\t\t                <li data-separator=\",\">\r\n                    <a href=\"https:\/\/litek-pharma.com\/en\/tag\/aisladores\/\" title=\"aisladores tag\"\r\n                       class=\"wcf-btn-default btn-rollover-left\">\r\n\t\t\t\t\t\taisladores                    <\/a>\r\n                <\/li>\r\n\t\t\t\t        <\/div>\r\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>shares<\/p>\n","protected":false},"author":1,"featured_media":10896,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[56],"tags":[57],"class_list":["post-10276","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-aisladores"],"_links":{"self":[{"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/posts\/10276","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/comments?post=10276"}],"version-history":[{"count":7,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/posts\/10276\/revisions"}],"predecessor-version":[{"id":11048,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/posts\/10276\/revisions\/11048"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/media\/10896"}],"wp:attachment":[{"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/media?parent=10276"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/categories?post=10276"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/litek-pharma.com\/en\/wp-json\/wp\/v2\/tags?post=10276"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}