{"id":6080,"date":"2026-04-12T12:00:33","date_gmt":"2026-04-12T12:00:33","guid":{"rendered":"https:\/\/ingenic.es\/?p=6080"},"modified":"2026-08-04T17:27:33","modified_gmt":"2026-08-04T17:27:33","slug":"cleanrooms-in-hospitals-and-laboratories","status":"publish","type":"post","link":"https:\/\/ingenic.es\/en\/cleanrooms-in-hospitals-and-laboratories\/","title":{"rendered":"Cleanrooms in hospitals and laboratories: key differences"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Although all of them maintain a controlled level of contamination, <strong>cleanrooms in hospitals and laboratories<\/strong> have opposing functional goals: in healthcare, the patient is protected, while in <strong>R&amp;D<\/strong>, the process is protected. Understanding these differences is crucial for design, operation and regulatory compliance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this article we look at the main differences between <strong>cleanrooms in hospitals and laboratories<\/strong>, as well as the technical and regulatory requirements each must meet.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">What is a cleanroom<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">According to the <strong>ISO 14644-1<\/strong> standard, a cleanroom is an environment in which the concentration of airborne particles is kept within specific limits.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is achieved through <strong>HEPA\/ULPA filtration systems<\/strong>, <strong>airflow control<\/strong> and <strong>differential pressures between zones<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The design, operation and maintenance of these rooms depend on their level of cleanliness (<em>ISO class<\/em>) and the nature of the process carried out inside them.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Cleanrooms in hospitals<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Hospital cleanrooms<\/strong> are installed in areas where patient safety and the sterility of the environment are critical. Their main purpose is to protect patients and healthcare staff from microbial or particulate contamination.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Hospital areas that require cleanrooms:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>High-complexity operating rooms.<\/li>\n\n\n\n<li>Transplant rooms and burn units.<\/li>\n\n\n\n<li>Sterile medication preparation rooms (hospital pharmacy).<\/li>\n\n\n\n<li>Clinical and pathology laboratories.<\/li>\n\n\n\n<li>Sterilization and isolation areas.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Technical characteristics:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Positive pressure to prevent the entry of external contaminants.<\/li>\n\n\n\n<li>HEPA H14 filtration, with 99.995% efficiency.<\/li>\n\n\n\n<li>Air changes: between 15 and 60 per hour, depending on the area.<\/li>\n\n\n\n<li>Strict temperature control (20\u00b0C \u2013 24\u00b0C) and humidity (40% \u2013 60%).<\/li>\n\n\n\n<li>Smooth, non-porous materials resistant to disinfection.<\/li>\n\n\n\n<li>Access points with air showers or airlocks for staff and materials.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">In hospitals, the priority is to guarantee the sterility and biosafety of the clinical environment.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Cleanrooms in R&amp;D and quality control (pharma\/biotechnology)<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Cleanrooms in laboratories<\/strong> focus more on protecting the process or samples than on protecting staff. These facilities are used in research, development and quality control, where the precision and purity of results are essential.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Types of laboratories that use cleanrooms:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pharmaceutical and biotechnological laboratories.<\/li>\n\n\n\n<li>Microbiology and molecular biology laboratories.<\/li>\n\n\n\n<li>Industrial quality control laboratories.<\/li>\n\n\n\n<li>Optical, electronic and micro-assembly laboratories.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Technical characteristics:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>May operate under positive or negative pressure, depending on the type of material handled.<\/li>\n\n\n\n<li>Filtration through HEPA or ULPA systems according to ISO classification.<\/li>\n\n\n\n<li>Laminar airflow control (for critical zones) or turbulent (auxiliary zones).<\/li>\n\n\n\n<li>Stable temperature between 19\u00b0C and 22\u00b0C, with humidity adjustable according to the process.<\/li>\n\n\n\n<li>Integrated equipment: biological safety cabinets, pass-through boxes, dedicated HVAC.<\/li>\n\n\n\n<li>Cleaning, access and clothing protocols defined by biological risk level (BSL).<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">In laboratories, the goal is to prevent contamination of samples or trials, ensuring the reliability of results.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Key differences between hospital and laboratory cleanrooms<\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Characteristic<\/th><th>Hospital cleanrooms<\/th><th>Laboratory cleanrooms<\/th><\/tr><\/thead><tbody><tr><td>Purpose<\/td><td>Protect the patient and staff.<\/td><td>Protect the process, samples or product.<\/td><\/tr><tr><td>Differential pressure<\/td><td>Positive (air flows out of the room).<\/td><td>Positive or negative depending on risk.<\/td><\/tr><tr><td>Type of contaminant controlled<\/td><td>Microbiological.<\/td><td>Particulate, chemical or biological.<\/td><\/tr><tr><td>Main regulations<\/td><td>ISO 14644 + Spanish UNE hospital standards + hospital pharmacy GMP.<\/td><td>ISO 14644 + GMP + BSL (biosafety levels).<\/td><\/tr><tr><td>Filtration<\/td><td>HEPA H14 filters.<\/td><td>HEPA H14 or ULPA U15\u2013U17.<\/td><\/tr><tr><td>Monitoring and traceability<\/td><td>Continuous microbiological monitoring.<\/td><td>Monitoring of particles, gases or differential pressure.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\">Applicable regulations and certifications<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Both hospitals and laboratories must comply with the following standards:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 14644-1 \/ -2 \/ -3: classification and cleanliness testing.<\/li>\n\n\n\n<li>GMP (<em>Good Manufacturing Practices<\/em>).<\/li>\n\n\n\n<li>EN 12128: microbiology and biotechnology laboratories.<\/li>\n\n\n\n<li>UNE 100713: operating rooms and hospital clean areas (Spain).<\/li>\n\n\n\n<li>FDA 21 CFR Part 211: pharmaceutical production.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These regulations ensure air quality, staff safety and the traceability of the controlled environment.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Design and maintenance<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The design of both types of rooms should include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Independent <strong><a href=\"https:\/\/ingenic.es\/en\/hvac\/\" data-type=\"page\" data-id=\"5763\">HVAC systems<\/a><\/strong> with pressure and temperature control.<\/li>\n\n\n\n<li>Airtight, smooth materials resistant to chemical products.<\/li>\n\n\n\n<li>Automatic airtight doors.<\/li>\n\n\n\n<li>Surfaces free of joints or sharp corners.<\/li>\n\n\n\n<li>Regular maintenance of filters and sensors.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Maintenance includes validated cleaning, review of differential pressures, sensor calibration and annual <strong>ISO 14644<\/strong> revalidation.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Although they share the same technology, hospital and laboratory cleanrooms have opposing goals: protecting the patient or protecting the process.<\/p>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\">Although <strong>hospital and laboratory cleanrooms<\/strong> share the same underlying principle \u2014 controlling contamination \u2014 their goals and configurations differ.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">While in the hospital setting the priority is to protect the patient, in the laboratory the aim is to preserve the purity of the process or sample.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">At <strong>ISL Salas Limpias<\/strong>, we design and install custom <strong>cleanrooms<\/strong> for hospitals, laboratories and research centers, complying with <strong>ISO 14644<\/strong>, <strong>GMP<\/strong> and <strong>UNE<\/strong> standards.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Contact us for advice on the design, installation and validation of your next hospital or laboratory cleanroom.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cleanrooms in hospitals and laboratories: learn their key differences (protection vs. process). Pressure requirements (positive\/negative), regulations (UNE\/BSL) and biosafety.<\/p>\n","protected":false},"author":2,"featured_media":6079,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[105,107,89],"tags":[],"class_list":["post-6080","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cleanroom-2","category-healthcare","category-hospitals"],"acf":[],"_links":{"self":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts\/6080","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/comments?post=6080"}],"version-history":[{"count":2,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts\/6080\/revisions"}],"predecessor-version":[{"id":6258,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts\/6080\/revisions\/6258"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/media\/6079"}],"wp:attachment":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/media?parent=6080"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/categories?post=6080"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/tags?post=6080"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}