{"id":987499967,"date":"2025-06-18T16:40:47","date_gmt":"2025-06-18T14:40:47","guid":{"rendered":"https:\/\/albian.es\/validations\/"},"modified":"2025-06-24T07:43:04","modified_gmt":"2025-06-24T05:43:04","slug":"validations","status":"publish","type":"page","link":"https:\/\/albian.es\/en\/validations\/","title":{"rendered":"Validations"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; background_image=&#8221;https:\/\/albian.es\/wp-content\/uploads\/cabecera-validatec-2.png&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;El mejor camino para la adaptaci\u00f3n GMP&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#12316d&#8221; title_font_size=&#8221;40px&#8221; min_height=&#8221;41px&#8221; custom_margin=&#8221;-2px|||||&#8221; custom_padding=&#8221;0px||26px|||&#8221; title_text_shadow_style=&#8221;preset5&#8243; title_text_shadow_color=&#8221;rgba(252,252,252,0.4)&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_heading][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||5px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||47px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;Ensuring Excellence: Validations and Qualifications That Meet and Exceed Regulatory Standards.&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#12316d&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; custom_margin=&#8221;-6px|||||&#8221;][\/et_pb_heading][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-15px|||||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p data-sourcepos=\"2:1-2:539\">To maintain rigorous control and ensure that facilities and equipment are in optimal condition and comply with regulations,<span class=\"apple-converted-space\"> <\/span>a set of<strong> qualification\/validation tests and procedures<\/strong><span class=\"apple-converted-space\"> <\/span>are required. These vary in intensity depending on the industry and the criticality of the process.<\/p>\n<div><span>The key in regulated sectors <\/span>(pharmaceutical, veterinary, and cosmetic) is <strong><span>Qualification<\/span><\/strong> <span>(for facilities and equipment) and<\/span> <strong><span>Validation<\/span><\/strong> <span>(for processes). These are documented procedures that demonstrate an equipment, system, or facility is suitable for its intended use, and that a process will consistently produce a predetermined result.<\/span><\/div>\n<div><\/div>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/albian.es\/wp-content\/uploads\/validatec-9-2.png&#8221; alt=&#8221;Albian CARE: Facilities and Equipment Maintenance&#8221; title_text=&#8221;Albian: Validation and Qualification of Facilities, Pharma Processes, and Equipment. Validatec. &#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-13px|||||&#8221; custom_padding=&#8221;2px||0px|||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-4px|auto||auto||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_heading title=&#8221;The Foundation and Guarantee of Your GMP. Our Rigorous Process. Calibrating Excellence.  &#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#96c121&#8243; title_font_size=&#8221;40px&#8221; custom_margin=&#8221;||-2px|||&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_heading][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_header title=&#8221;Validations and Qualifications for Cleanroom Facilities and Critical Controlled Areas&#8221; subhead=&#8221;Each facility is a unique ecosystem where quality, safety, and innovation must coexist under the watchful eye of regulations. Whether in biotechnology, food, medical devices, cosmetics, or any regulated sector, the validation and qualification of your facilities are the key to transforming legal requirements into competitive advantages.&lt;br&gt;Our approach goes beyond mere compliance: we design and document robust environments, adapted to the challenges of each industry, ensuring error-free processes and readiness for international audits. This way, your spaces don&apos;t just comply, they make a difference in a world where excellence is the norm.   &#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-12px||20px|||&#8221; custom_padding=&#8221;39px|||||&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;17px||42px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;2px|||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_slider _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; width=&#8221;99.7%&#8221; custom_padding=&#8221;38px||44px|31px||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; min_height=&#8221;510px&#8221;][et_pb_slide heading=&#8221;1. Air Cleanliness Classification (Non-Viable Particle Counting)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_border_width=&#8221;1px&#8221; button_border_radius=&#8221;30px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_transition=&#8221;on&#8221; sticky_enabled=&#8221;0&#8243; header_text_align=&#8221;left&#8221; header_level=&#8221;h2&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To determine airborne particulate concentration for cleanroom classification (e.g., ISO 5, ISO 7, ISO 8, or Grades A, B, C, D as per NCF\/GMP).<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Laser particle counters are used to measure the number of particles of a specific size (e.g., \u22650.5\u03bcm, \u22655\u03bcm) per cubic meter of air. This is performed under both &#8220;at rest&#8221; and &#8220;in operation&#8221; conditions. <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;2. Microbiological Monitoring of Air and Surfaces&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_border_width=&#8221;1px&#8221; button_border_radius=&#8221;30px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_transition=&#8221;on&#8221; header_text_align=&#8221;left&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose:<\/strong> To detect the presence of microorganisms (bacteria, fungi) in the environment and on surfaces, indicating biocontamination.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method:<\/strong><\/p>\n<ul style=\"text-align: left;\">\n<li><strong>Air Quality Monitoring<\/strong>: Passive Methods: Settling plates (for general microbial fallout).<br \/>Active Methods: Active air samplers (impaction onto agar plates for precise microbial counts).<\/li>\n<li><strong>Surfaces<\/strong>: Contact plates (RODAC) or moistened swabs on critical areas (equipment surfaces, floors, walls)<\/li>\n<li><strong>Personnel<\/strong>: Glove and Garment Sampling<\/li>\n<\/ul>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;3. Differential Pressure Monitoring (Pressure Cascade)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_border_width=&#8221;1px&#8221; button_border_radius=&#8221;30px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_transition=&#8221;on&#8221; header_text_align=&#8221;left&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: Ensure that cleaner areas maintain positive pressure relative to adjacent less-clean areas to prevent contamination ingress.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Differential pressure gauges are used to continuously measure and record the pressure difference between the different zones.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;4. Airflow Testing (Velocity and Uniformity)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To verify that air flows uniformly and at the correct velocity, especially in unidirectional (laminar) flow areas such as cabins or isolators.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: We use anemometers to measure air velocity and employ smoke generation techniques (or &#8220;smoke tests&#8221;) to visualize airflow patterns and ensure there are no eddies or dead zones.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;5. HEPA\/ULPA Filter Integrity&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose:<\/strong> To verify that High-Efficiency Particulate Air (HEPA) and Ultra-Low Penetration Air (ULPA) filters are leak-free and functioning correctly.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Aerosol Leak Testing (e.g., DOP\/PAO Test). This involves introducing an aerosol at the filter&#8217;s inlet and scanning the filter surface with an aerosol photometer to detect leaks.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;6.Temperature and Relative Humidity Control&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To maintain environmental conditions within specified ranges, ensuring both product stability and personnel comfort.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Continuous monitoring with calibrated sensors, with alarms in case of deviations.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;7. Air Cleaning Recovery Tests&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To assess a cleanroom&#8217;s ability to return to its specified clean state after a particle-generating event (e.g., entry of personnel or materials).<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Controlled introduction of a particle aerosol and measurement of the time it takes for the room to return to its cleanliness classification.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;8. Water Quality (AP, PW, WFI)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: For the pharmaceutical and veterinary sectors, the quality of water used in production or cleaning is critical.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Physicochemical analysis (conductivity, TOC &#8211; Total Organic Carbon) and microbiological analysis (total microbial count, detection of specific pathogens, endotoxins).<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;9. Calibration (Pressure Probes, Temperature Probes, etc.)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To ensure that all measuring instruments and equipment in the facility operate with precision and reliability, guaranteeing compliance with current regulations.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Key sensors and devices such as pressure and temperature probes, humidity sensors, flowmeters, pH meters, level sensors, and other critical equipment are calibrated using certified reference standards and standardized procedures. The results are meticulously documented to maintain traceability and facilitate audits. <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;10. Design Qualification (DQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To verify and document that the design of the facility, equipment, or system complies with the regulatory, safety, and operational requirements defined by the user and current legislation.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Review of technical documentation, analysis of specifications, risk assessment, and verification that the proposed design is suitable for its intended purpose and compatible with applicable regulations. A DQ (Design Qualification) protocol is generated, containing all evidence and justifications. <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;11. Installation Qualification (IQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To ensure that the installation of the equipment or system has been carried out in accordance with the approved design, and that all critical components are correctly installed and documented.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Physical inspection, documentation review (manuals, material certificates, blueprints), and verification of connections, utilities, and auxiliary systems. The conformity of each key element concerning the design and regulatory requirements is documented in the IQ protocol. <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;12. Operational Qualification (OQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To demonstrate that the equipment or system functions correctly within defined operating limits and under all anticipated conditions of use.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Execution of functional tests, operational simulations, and verification of alarms, controls, and critical parameters. The results of each test are documented, and operational parameters are adjusted if necessary. The OQ protocol compiles all evidence of operation in accordance with the requirements.  <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;13. Performance Qualification (PQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To confirm that the equipment, system, or process produces consistent and reproducible results under real operating conditions, including both normal situations and extreme limits.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Performance tests are conducted under routine conditions and in scenarios of maximum demand. Performance data is collected, system robustness is evaluated, and conformity with the acceptance criteria defined in the PQ protocol is documented<strong>.<\/strong> <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;14. Risk Analysis&#8221; button_text=&#8221;Clicks&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To identify, evaluate, and control risks associated with facilities, equipment, and processes, prioritizing preventive actions to ensure safety, quality, and regulatory compliance.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: We apply methodologies such as FMEA (Failure Modes and Effects Analysis), HACCP, or criticality analysis. Critical points are identified, probabilities and impacts are evaluated, and controls and mitigation measures are established. The entire process is documented and periodically reviewed.  <\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;15. Validation Master Plan (VMP)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243; header_level=&#8221;h2&#8243; header_text_align=&#8221;left&#8221;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To establish the overall strategy and planning for all validation and qualification activities of a facility, equipment, or system, ensuring comprehensive compliance with regulatory requirements.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Validation Master Plan (VMP). This involves developing a master document that defines the scope, acceptance criteria, responsibilities, timelines, and required documentation for each stage of validation and qualification. The VMP serves as a central reference for audits and regulatory reviews. <\/p>\n<p>[\/et_pb_slide][\/et_pb_slider][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/albian.es\/wp-content\/uploads\/validaciones-instalaciones-2.png&#8221; alt=&#8221;Albian life-science&#8221; title_text=&#8221;Albian: Validation and Qualification of Critical Facilities and Pharma Processes&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;|||-9px||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_header title=&#8221;Qualified Equipment: Precision and Performance for Operational Excellence.&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-12px|||||&#8221; custom_padding=&#8221;39px|||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div><span>In any regulated environment, from research laboratories to production plants, equipment qualification and validation is the first step to ensuring reliable and reproducible results. It&#8217;s not just about complying with GMP, ISO, or other regulations; it&#8217;s an opportunity to elevate your operations, minimize risks, and optimize efficiency. We implement personalized, documented strategies aligned with international standards so that every piece of equipment\u2014simple or complex\u2014functions as a perfect cog within your quality system. Because true innovation begins when technology and regulation meet in harmony.   <\/span><\/div>\n<div><\/div>\n<p>[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;40px|||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;2px|0px||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_slider _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; width=&#8221;99.7%&#8221; custom_padding=&#8221;43px||44px|31px||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; header_text_align=&#8221;left&#8221;][et_pb_slide heading=&#8221;1. Design Qualification (DQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_border_width=&#8221;1px&#8221; button_border_radius=&#8221;30px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_transition=&#8221;on&#8221; sticky_enabled=&#8221;0&#8243; header_text_align=&#8221;left&#8221;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To verify that the equipment&#8217;s design is suitable for its intended use and complies with user requirements and regulations.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Testing\/Documentation:<\/strong> Review of blueprints, manufacturer specifications, and risk assessment.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;2. Installation Qualification (IQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_border_width=&#8221;1px&#8221; button_border_radius=&#8221;30px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_transition=&#8221;on&#8221; header_text_align=&#8221;left&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose:<\/strong> To ensure that the equipment has been correctly installed in accordance with manufacturer specifications, drawings, and regulations.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Tests\/Controls:<\/strong><\/p>\n<ul>\n<li style=\"text-align: left;\">Verification of Correct Installation of Components, Piping, and Connections<\/li>\n<li style=\"text-align: left;\">Verification of Correct Installation of Components, Piping, and Connections<\/li>\n<li style=\"text-align: left;\">Verification that auxiliary services (water, air, steam) have been installed with the required quality.<\/li>\n<li style=\"text-align: left;\">Verification of Technical Documentation and Manuals<\/li>\n<li style=\"text-align: left;\">Verification of Equipment Construction Materials in Contact with the Product<\/li>\n<\/ul>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;3. Operational Qualification (OQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_border_width=&#8221;1px&#8221; button_border_radius=&#8221;30px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_transition=&#8221;on&#8221; header_text_align=&#8221;left&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To demonstrate that the equipment consistently operates within the defined operating ranges (including upper and lower limits).<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Tests\/Controls<\/strong><\/p>\n<ul>\n<li style=\"text-align: left;\">Functional Testing of All Equipment Components and Subsystems<\/li>\n<li style=\"text-align: left;\">Verification of Alarms, Interlocks, and Safety Functions<\/li>\n<li style=\"text-align: left;\">Critical Equipment Control Point Testing (e.g., temperature, pressure, speed, dosage control) within their operational ranges.<\/li>\n<li style=\"text-align: left;\">Verification of Operational Repeatability<\/li>\n<\/ul>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;4. Performance Qualification (PQ)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To demonstrate that the equipment functions consistently and reproducibly for the specific process or product it was designed for under actual use conditions.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Tests\/Controls:<\/strong><\/p>\n<ul style=\"text-align: left;\">\n<li>Production of product batches under normal operating conditions, demonstrating that a product meeting quality specifications is obtained.<\/li>\n<li>Stability, uniformity, purity, etc. tests of the product processed by the equipment.<\/li>\n<\/ul>\n<p style=\"font-weight: 400; text-align: left;\"><span style=\"font-weight: 400;\">This is often linked with process validation.<\/span><\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;5. Calibration&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To ensure that the equipment&#8217;s measuring instruments (thermometers, pressure gauges, scales, flow meters, etc.) provide accurate readings within acceptable tolerances.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Comparing instrument readings with a traceable reference standard, at defined intervals.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;6. Method: Preventive and Corrective Maintenance&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose:<\/strong> To ensure the reliability and continuous proper functioning of equipment.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Establishing maintenance programs based on manufacturer recommendations, experience, and risk analysis.<\/p>\n<p>[\/et_pb_slide][et_pb_slide heading=&#8221;7. Method: Cleaning Qualification (if applicable)&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_text_align=&#8221;left&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Purpose<\/strong>: To demonstrate that equipment cleaning procedures are effective in removing product residues, detergents, and microorganisms, thereby preventing cross-contamination.<\/p>\n<p style=\"font-weight: 400; text-align: left;\"><strong>Method<\/strong>: Surface sampling (swabs, rinses) after cleaning and analysis of chemical or microbiological residues.<\/p>\n<p>[\/et_pb_slide][\/et_pb_slider][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/albian.es\/wp-content\/uploads\/validaciones-equipos-2.png&#8221; alt=&#8221;Albian life-science&#8221; title_text=&#8221;validations-equipment&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;|||-9px||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;117deg&#8221; background_color_gradient_stops=&#8221;rgba(255,255,255,0) 56%|rgba(46,55,107,0.85) 100%&#8221; background_image=&#8221;https:\/\/albian.es\/wp-content\/uploads\/Cartel-albian-scaled.jpg&#8221; parallax=&#8221;on&#8221; height=&#8221;300px&#8221; height_tablet=&#8221;300px&#8221; height_phone=&#8221;450px&#8221; height_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;CONTACT US&#8221; icon_placement=&#8221;left&#8221; image_icon_width=&#8221;123%&#8221; content_max_width=&#8221;100%&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_level=&#8221;h1&#8243; header_text_align=&#8221;right&#8221; header_text_color=&#8221;#12316d&#8221; header_font_size=&#8221;43px&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_font_size=&#8221;18px&#8221; position_origin_a=&#8221;center_center&#8221; position_origin_f=&#8221;center_left&#8221; width=&#8221;100%&#8221; custom_margin=&#8221;50px||||false|false&#8221; animation=&#8221;off&#8221; border_color_bottom=&#8221;#98caec&#8221; border_style_bottom=&#8221;dotted&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: right;\"><span style=\"color: #003366;\">Our team will provide you with the best turnkey solution for your project.<\/span><\/p>\n<p>[\/et_pb_blurb][et_pb_button button_url=&#8221;@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6Ijc3MjQiLCJlbmFibGVfaHRtbCI6Im9mZiJ9fQ==@&#8221; button_text=&#8221;Contact&#8221; button_alignment=&#8221;right&#8221; _builder_version=&#8221;4.27.4&#8243; _dynamic_attributes=&#8221;button_url&#8221; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;16px&#8221; button_text_color=&#8221;#12316d&#8221; button_bg_color=&#8221;RGBA(255,255,255,0)&#8221; button_border_width=&#8221;1px&#8221; button_border_color=&#8221;#12316d&#8221; button_border_radius=&#8221;30px&#8221; position_origin_a=&#8221;bottom_right&#8221; position_origin_f=&#8221;bottom_center&#8221; custom_margin=&#8221;30px||||false|false&#8221; global_colors_info=&#8221;{}&#8221; button_bg_color__hover_enabled=&#8221;on|desktop&#8221; button_bg_color__hover=&#8221;#98caec&#8221; button_bg_enable_color__hover=&#8221;on&#8221;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>To maintain rigorous control and ensure that facilities and equipment are in optimal condition and comply with regulations, a set of qualification\/validation tests and procedures are required. These vary in intensity depending on the industry and the criticality of the process. The key in regulated sectors (pharmaceutical, veterinary, and cosmetic) is Qualification (for facilities and [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":9204,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-987499967","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/pages\/987499967","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/comments?post=987499967"}],"version-history":[{"count":2,"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/pages\/987499967\/revisions"}],"predecessor-version":[{"id":987499969,"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/pages\/987499967\/revisions\/987499969"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/media\/9204"}],"wp:attachment":[{"href":"https:\/\/albian.es\/en\/wp-json\/wp\/v2\/media?parent=987499967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}