Testing, Adjusting & Balancing
Cleanroom Performance Testing Service
ISO 14644 Compliant Testing for Pharmaceutical, Healthcare & Manufacturing Facilities
Shan International delivers comprehensive cleanroom performance testing and certification services across Saudi Arabia, ensuring controlled environments meet stringent ISO 14644 classifications and regulatory requirements. As a NEBB-certified contractor with specialized Clean Room Testing (CRT) credentials, we conduct complete validation protocols for pharmaceutical manufacturing, hospital operating rooms, bio-safety laboratories, and microelectronics facilities. Our certified engineers utilize calibrated instrumentation to verify airflow patterns, particle counts, pressure differentials, and environmental conditions throughout the Kingdom.
Trusted TAB Services in Saudi Arabia for Accurate HVAC Performance
Certified TAB Contractors KSA Delivering Balanced, Efficient Airflow
NEBB Certified HVAC Testing and Balancing Services You Can Rely On
Precise HVAC Commissioning and TAB Reports for Long-Term Efficiency
Trusted TAB Services in Saudi Arabia for Accurate HVAC Performance
Certified TAB Contractors KSA Delivering Balanced, Efficient Airflow
NEBB Certified HVAC Testing and Balancing Services You Can Rely On
Precise HVAC Commissioning and TAB Reports for Long-Term Efficiency
Get Your Cleanroom Professionally Tested & ISO Certified
Cleanroom performance testing is essential for maintaining validated controlled environments in pharmaceutical manufacturing, healthcare facilities, and precision manufacturing operations throughout Saudi Arabia. Proper testing ensures cleanrooms achieve specified ISO classifications, maintain regulatory compliance, and provide the contamination control necessary for product quality and patient safety.
At Shan International, our NEBB-certified cleanroom testing protocols encompass comprehensive validation of airflow performance, filtration efficiency, environmental conditions, and contamination control measures. We conduct testing at three critical stages: as-built (empty cleanroom), at-rest (equipped but unoccupied), and in-operation (full production conditions), providing complete documentation for each qualification phase.
We’ve successfully certified cleanrooms for prestigious clients including pharmaceutical manufacturers, major hospitals, research institutions, and high-tech manufacturing facilities throughout the Kingdom. Our proven expertise ensures your critical environments maintain validated performance, regulatory compliance, and operational excellence year-round.
Cleanroom Performance Testing Services
FAQ
Frequently Asked Questions
This section addresses common questions about cleanroom testing, certification, and validation requirements in Saudi Arabia. From understanding ISO classifications to maintaining regulatory compliance, our NEBB-certified specialists provide expert guidance on controlled environment performance verification.
What is cleanroom performance testing and why is it critical in Saudi Arabia?
Cleanroom performance testing is a comprehensive validation process verifying that controlled environments achieve specified ISO classifications and maintain proper contamination control. Testing encompasses airflow measurements, particle count verification, filter integrity checks, pressure differential monitoring, environmental condition assessments, and functional performance evaluations.
In Saudi Arabia's pharmaceutical, healthcare, and high-tech manufacturing sectors, cleanroom performance directly impacts product quality, patient safety, and regulatory compliance. The Kingdom's pharmaceutical industry must meet Saudi FDA requirements aligned with international GMP standards including EU-GMP Annex 1, which mandates regular cleanroom qualification and monitoring. Healthcare facilities pursuing CBAHI accreditation or JCI certification require validated isolation rooms and sterile processing areas.
Cleanroom testing occurs at three qualification stages: as-built testing verifies construction completion without equipment, at-rest testing confirms performance with installed equipment but no personnel, and in-operation testing validates functionality during actual production or clinical activities. Each stage requires specific testing protocols documented according to NEBB, ISO 14644, and IEST standards. Facilities throughout Riyadh, Jeddah, Dammam, and the Eastern Province depend on certified testing to maintain validated operations and regulatory compliance.In Saudi Arabia's pharmaceutical, healthcare, and high-tech manufacturing sectors, filter integrity directly impacts product quality, patient safety, and regulatory compliance. Even microscopic filter leaks can introduce contamination that compromises sterile products, endangers immunocompromised patients, or ruins sensitive manufacturing processes. The Kingdom's stringent adherence to international GMP standards, ISO clean room classifications, and healthcare safety protocols makes regular filter testing mandatory for facilities throughout Riyadh, Jeddah, Dammam, and the Eastern Province.
NEBB-certified testing ensures filters meet specified efficiency ratings (typically 99.97% for HEPA H13, 99.995% for HEPA H14, and 99.9995% for ULPA U15) without bypass leaks that could invalidate controlled environment classifications.
In Saudi Arabia's pharmaceutical, healthcare, and high-tech manufacturing sectors, cleanroom performance directly impacts product quality, patient safety, and regulatory compliance. The Kingdom's pharmaceutical industry must meet Saudi FDA requirements aligned with international GMP standards including EU-GMP Annex 1, which mandates regular cleanroom qualification and monitoring. Healthcare facilities pursuing CBAHI accreditation or JCI certification require validated isolation rooms and sterile processing areas.
Cleanroom testing occurs at three qualification stages: as-built testing verifies construction completion without equipment, at-rest testing confirms performance with installed equipment but no personnel, and in-operation testing validates functionality during actual production or clinical activities. Each stage requires specific testing protocols documented according to NEBB, ISO 14644, and IEST standards. Facilities throughout Riyadh, Jeddah, Dammam, and the Eastern Province depend on certified testing to maintain validated operations and regulatory compliance.In Saudi Arabia's pharmaceutical, healthcare, and high-tech manufacturing sectors, filter integrity directly impacts product quality, patient safety, and regulatory compliance. Even microscopic filter leaks can introduce contamination that compromises sterile products, endangers immunocompromised patients, or ruins sensitive manufacturing processes. The Kingdom's stringent adherence to international GMP standards, ISO clean room classifications, and healthcare safety protocols makes regular filter testing mandatory for facilities throughout Riyadh, Jeddah, Dammam, and the Eastern Province.
NEBB-certified testing ensures filters meet specified efficiency ratings (typically 99.97% for HEPA H13, 99.995% for HEPA H14, and 99.9995% for ULPA U15) without bypass leaks that could invalidate controlled environment classifications.
What are ISO cleanroom classifications and which applies to my facility?
ISO 14644-1 establishes nine cleanroom classifications (ISO Class 1 through ISO Class 9) based on maximum allowable particle concentrations. Lower numbers indicate cleaner environments with stricter particle limits. ISO Class 5 represents extremely clean conditions suitable for pharmaceutical aseptic processing, allowing maximum 3,520 particles ≥0.5μm per cubic meter. ISO Class 7 suits non-sterile pharmaceutical manufacturing and hospital operating rooms, while ISO Class 8 serves general pharmaceutical production and laboratory environments.
Pharmaceutical sterile manufacturing requires ISO Class 5 for critical aseptic operations with surrounding ISO Class 7 or 8 background areas per EU-GMP guidelines. Hospital operating rooms typically maintain ISO Class 7 or 8 depending on procedure types. Bio-safety laboratories range from ISO Class 7 to 8 based on containment requirements. Microelectronics manufacturing often demands ISO Class 4 or 5 for semiconductor fabrication.
Saudi FDA regulations for pharmaceutical manufacturers align with international GMP requiring appropriate classifications for each manufacturing operation. Shan International's certified specialists help determine proper classifications for your specific applications, conduct testing to verify achievement, and provide documentation supporting regulatory submissions. We've successfully certified cleanrooms across all ISO classifications for facilities throughout Saudi Arabia, ensuring your controlled environments meet applicable standards.Hospital operating rooms, isolation units, and critical care areas should undergo filter testing annually or when air quality concerns arise. Bio-safety laboratories working with infectious agents require testing after installation, following any maintenance, and annually. Clean room facilities must test filters during commissioning, after re-classification, and at intervals determined by quality management systems—typically annually.
Saudi Arabian healthcare facilities accredited by CBAHI (Saudi Central Board for Accreditation of Healthcare Institutions) and pharmaceutical manufacturers must demonstrate regular filter testing to maintain certifications. Shan International provides customized testing schedules aligned with your specific regulatory requirements, operational demands, and risk assessment protocols for facilities throughout the Kingdom.
Pharmaceutical sterile manufacturing requires ISO Class 5 for critical aseptic operations with surrounding ISO Class 7 or 8 background areas per EU-GMP guidelines. Hospital operating rooms typically maintain ISO Class 7 or 8 depending on procedure types. Bio-safety laboratories range from ISO Class 7 to 8 based on containment requirements. Microelectronics manufacturing often demands ISO Class 4 or 5 for semiconductor fabrication.
Saudi FDA regulations for pharmaceutical manufacturers align with international GMP requiring appropriate classifications for each manufacturing operation. Shan International's certified specialists help determine proper classifications for your specific applications, conduct testing to verify achievement, and provide documentation supporting regulatory submissions. We've successfully certified cleanrooms across all ISO classifications for facilities throughout Saudi Arabia, ensuring your controlled environments meet applicable standards.Hospital operating rooms, isolation units, and critical care areas should undergo filter testing annually or when air quality concerns arise. Bio-safety laboratories working with infectious agents require testing after installation, following any maintenance, and annually. Clean room facilities must test filters during commissioning, after re-classification, and at intervals determined by quality management systems—typically annually.
Saudi Arabian healthcare facilities accredited by CBAHI (Saudi Central Board for Accreditation of Healthcare Institutions) and pharmaceutical manufacturers must demonstrate regular filter testing to maintain certifications. Shan International provides customized testing schedules aligned with your specific regulatory requirements, operational demands, and risk assessment protocols for facilities throughout the Kingdom.
How often should cleanrooms be tested in Saudi pharmaceutical and healthcare facilities?
Testing frequency depends on facility type, regulatory requirements, classification level, and operational criticality. Pharmaceutical manufacturing cleanrooms require initial qualification testing during commissioning, periodic re-qualification testing, and continuous monitoring per validation protocols. EU-GMP and Saudi FDA guidelines mandate complete re-qualification at defined intervals, typically annually for critical ISO Class 5 areas and every 2 years for support zones.
Following significant modifications affecting airflow, filtration, or room configuration, complete re-qualification testing is mandatory before resuming production. Many pharmaceutical facilities conduct abbreviated quarterly or semi-annual testing between full annual qualifications to maintain validation status. Particle counting, pressure monitoring, and environmental conditions require continuous or frequent periodic verification.
Hospital operating rooms and isolation units typically undergo annual testing unless problems arise or modifications occur. Bio-safety laboratories require testing after commissioning, following modifications, annually thereafter, and when certification renewals become necessary. Research facilities may test semi-annually or annually based on internal protocols.
Shan International works with Saudi Arabian facilities to develop customized testing schedules meeting regulatory requirements while optimizing operational continuity. We provide both comprehensive annual qualifications and abbreviated quarterly monitoring programs supporting validation maintenance for pharmaceutical manufacturers and healthcare facilities throughout Riyadh, Jeddah, Dammam, and the wider Kingdom.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
Following significant modifications affecting airflow, filtration, or room configuration, complete re-qualification testing is mandatory before resuming production. Many pharmaceutical facilities conduct abbreviated quarterly or semi-annual testing between full annual qualifications to maintain validation status. Particle counting, pressure monitoring, and environmental conditions require continuous or frequent periodic verification.
Hospital operating rooms and isolation units typically undergo annual testing unless problems arise or modifications occur. Bio-safety laboratories require testing after commissioning, following modifications, annually thereafter, and when certification renewals become necessary. Research facilities may test semi-annually or annually based on internal protocols.
Shan International works with Saudi Arabian facilities to develop customized testing schedules meeting regulatory requirements while optimizing operational continuity. We provide both comprehensive annual qualifications and abbreviated quarterly monitoring programs supporting validation maintenance for pharmaceutical manufacturers and healthcare facilities throughout Riyadh, Jeddah, Dammam, and the wider Kingdom.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
What testing standards and regulations govern cleanrooms in Saudi Arabia?
Saudi Arabian cleanroom testing must comply with multiple international and local standards. ISO 14644 provides the primary framework with ISO 14644-1 defining classification requirements, ISO 14644-2 establishing monitoring protocols, and ISO 14644-3 specifying testing methodologies. IEST Recommended Practices (IEST-RP-CC006 for testing and IEST-RP-CC034 for HEPA filters) offer detailed technical guidance.
Pharmaceutical facilities must meet EU-GMP Annex 1 requirements governing sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed manufacturers in the Kingdom. EU-GMP mandates specific cleanroom classifications, monitoring frequencies, and qualification protocols pharmaceutical companies must follow.
Healthcare facilities accredited by CBAHI (Saudi Central Board for Accreditation of Healthcare Institutions) must demonstrate proper environmental controls in operating rooms, isolation units, and sterile processing areas. Facilities pursuing Joint Commission International (JCI) accreditation face additional documentation requirements for infection control environments.
NEBB (National Environmental Balancing Bureau) provides procedural standards for cleanroom testing ensuring consistent methodology and documentation quality. Shan International's NEBB Clean Room Testing (CRT) certification demonstrates mastery of all applicable standards. Our testing protocols satisfy Saudi regulatory authorities while meeting international benchmarks, providing documentation packages supporting regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
Pharmaceutical facilities must meet EU-GMP Annex 1 requirements governing sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed manufacturers in the Kingdom. EU-GMP mandates specific cleanroom classifications, monitoring frequencies, and qualification protocols pharmaceutical companies must follow.
Healthcare facilities accredited by CBAHI (Saudi Central Board for Accreditation of Healthcare Institutions) must demonstrate proper environmental controls in operating rooms, isolation units, and sterile processing areas. Facilities pursuing Joint Commission International (JCI) accreditation face additional documentation requirements for infection control environments.
NEBB (National Environmental Balancing Bureau) provides procedural standards for cleanroom testing ensuring consistent methodology and documentation quality. Shan International's NEBB Clean Room Testing (CRT) certification demonstrates mastery of all applicable standards. Our testing protocols satisfy Saudi regulatory authorities while meeting international benchmarks, providing documentation packages supporting regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
What happens if cleanrooms fail performance testing in Saudi facilities?
Cleanroom test failures indicate performance deficiencies requiring investigation and remediation before validated operations can continue. Common failure causes include filter leaks, inadequate airflow, improper pressure relationships, equipment malfunctions, construction defects, or maintenance issues affecting environmental control systems.
When cleanrooms fail testing, our certified technicians conduct detailed investigations identifying specific deficiency sources. Particle count failures often trace to filter leaks requiring integrity testing and potential filter replacement. Airflow velocity failures may indicate fan problems, duct restrictions, or control system issues needing mechanical corrections. Pressure differential failures typically involve door seal problems, exhaust imbalances, or control damper malfunctions.
Shan International provides comprehensive troubleshooting services identifying root causes and recommending corrective actions. We work with mechanical contractors, equipment suppliers, and facility personnel implementing necessary repairs. Following corrections, we conduct re-testing verifying successful remediation and regulatory compliance restoration.
For pharmaceutical facilities in Saudi Arabia, cleanroom failures trigger deviation investigations, impact assessments, and potential production holds depending on severity and timing. Failed operating rooms may require procedure rescheduling until corrections complete. Our detailed documentation supports quality management responses, regulatory reporting obligations, and validation protocol requirements. We also provide recommendations preventing future failures through improved maintenance protocols, upgraded equipment, or enhanced monitoring procedures across facilities throughout Riyadh, Jeddah, Dammam, and the Kingdom.When filters fail testing, our certified technicians conduct detailed investigations to locate specific leak sources. Minor frame seal leaks sometimes respond to gasket adjustments or sealant application. However, media defects or significant seal failures require complete filter replacement to restore proper performance.
Shan International provides professional filter replacement services following NAFA (National Air Filtration Association) protocols. We safely remove contaminated filters, properly dispose of hazardous materials, install certified replacement units, and conduct integrity testing to verify leak-free performance. Our comprehensive approach minimizes facility downtime while ensuring regulatory compliance.
For pharmaceutical and healthcare facilities in Saudi Arabia, failed filters trigger deviation investigations, impact assessments, and potential product holds depending on severity and location. Our detailed documentation supports your quality management responses and regulatory reporting obligations. We also provide recommendations for preventing future failures through improved maintenance protocols or installation procedures across your facilities throughout the Kingdom.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
When cleanrooms fail testing, our certified technicians conduct detailed investigations identifying specific deficiency sources. Particle count failures often trace to filter leaks requiring integrity testing and potential filter replacement. Airflow velocity failures may indicate fan problems, duct restrictions, or control system issues needing mechanical corrections. Pressure differential failures typically involve door seal problems, exhaust imbalances, or control damper malfunctions.
Shan International provides comprehensive troubleshooting services identifying root causes and recommending corrective actions. We work with mechanical contractors, equipment suppliers, and facility personnel implementing necessary repairs. Following corrections, we conduct re-testing verifying successful remediation and regulatory compliance restoration.
For pharmaceutical facilities in Saudi Arabia, cleanroom failures trigger deviation investigations, impact assessments, and potential production holds depending on severity and timing. Failed operating rooms may require procedure rescheduling until corrections complete. Our detailed documentation supports quality management responses, regulatory reporting obligations, and validation protocol requirements. We also provide recommendations preventing future failures through improved maintenance protocols, upgraded equipment, or enhanced monitoring procedures across facilities throughout Riyadh, Jeddah, Dammam, and the Kingdom.When filters fail testing, our certified technicians conduct detailed investigations to locate specific leak sources. Minor frame seal leaks sometimes respond to gasket adjustments or sealant application. However, media defects or significant seal failures require complete filter replacement to restore proper performance.
Shan International provides professional filter replacement services following NAFA (National Air Filtration Association) protocols. We safely remove contaminated filters, properly dispose of hazardous materials, install certified replacement units, and conduct integrity testing to verify leak-free performance. Our comprehensive approach minimizes facility downtime while ensuring regulatory compliance.
For pharmaceutical and healthcare facilities in Saudi Arabia, failed filters trigger deviation investigations, impact assessments, and potential product holds depending on severity and location. Our detailed documentation supports your quality management responses and regulatory reporting obligations. We also provide recommendations for preventing future failures through improved maintenance protocols or installation procedures across your facilities throughout the Kingdom.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
Can cleanroom testing be performed while facilities remain operational?
Testing feasibility during operations depends on the specific tests required and facility type. Many routine monitoring tests including particle counting, pressure measurements, and environmental condition checks can be performed during normal operations with minimal disruption. These tests actually provide valuable data on cleanroom performance under real-world conditions.
However, comprehensive qualification testing typically requires cleanrooms be empty or at-rest. As-built testing occurs before equipment installation during construction completion. At-rest testing requires installed equipment but no personnel or production activities. Some tests like airflow visualization, recovery time measurements, and certain HEPA filter integrity scans work best without interference from operational activities.
Pharmaceutical manufacturing areas usually schedule comprehensive qualification testing during planned shutdowns, between production campaigns, or during scheduled maintenance periods. Hospital operating rooms undergo testing during off-hours or scheduled dark time between procedures. Laboratory cleanrooms often accommodate routine testing during normal operations while reserving comprehensive qualifications for scheduled downtime.
Shan International's experienced project managers coordinate testing schedules minimizing operational impact while ensuring comprehensive, compliant validation. We understand the unique challenges facing facilities across Saudi Arabia—from busy pharmaceutical production schedules to hospital operating room demands. Our flexible scheduling, efficient execution, and thorough planning maintain both production continuity and regulatory compliance for facilities throughout Riyadh, Jeddah, Dammam, and the Eastern Province.For pharmaceutical manufacturing areas, testing typically occurs during non-production periods with appropriate contamination control measures. Hospital operating rooms and critical care units can undergo testing during scheduled downtime between procedures. Laboratory and clean room environments often accommodate testing during normal operations with proper protocols.
However, some situations require temporary shutdown including initial commissioning tests, major system modifications, or when aerosol introduction poses unacceptable contamination risks. Our experienced project managers work closely with facility personnel to develop testing schedules that balance regulatory compliance needs with operational continuity.
Shan International's extensive experience testing facilities across Saudi Arabia—from active pharmaceutical manufacturing plants to busy hospital operating rooms—ensures minimal operational impact while delivering comprehensive, compliant filter integrity verification. We understand the unique challenges facing facilities in Riyadh, Jeddah, Dammam, and throughout the Kingdom, providing flexible scheduling and expert execution that maintains both production schedules and regulatory requirements.When filters fail testing, our certified technicians conduct detailed investigations to locate specific leak sources. Minor frame seal leaks sometimes respond to gasket adjustments or sealant application. However, media defects or significant seal failures require complete filter replacement to restore proper performance.
Shan International provides professional filter replacement services following NAFA (National Air Filtration Association) protocols. We safely remove contaminated filters, properly dispose of hazardous materials, install certified replacement units, and conduct integrity testing to verify leak-free performance. Our comprehensive approach minimizes facility downtime while ensuring regulatory compliance.
For pharmaceutical and healthcare facilities in Saudi Arabia, failed filters trigger deviation investigations, impact assessments, and potential product holds depending on severity and location. Our detailed documentation supports your quality management responses and regulatory reporting obligations. We also provide recommendations for preventing future failures through improved maintenance protocols or installation procedures across your facilities throughout the Kingdom.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
However, comprehensive qualification testing typically requires cleanrooms be empty or at-rest. As-built testing occurs before equipment installation during construction completion. At-rest testing requires installed equipment but no personnel or production activities. Some tests like airflow visualization, recovery time measurements, and certain HEPA filter integrity scans work best without interference from operational activities.
Pharmaceutical manufacturing areas usually schedule comprehensive qualification testing during planned shutdowns, between production campaigns, or during scheduled maintenance periods. Hospital operating rooms undergo testing during off-hours or scheduled dark time between procedures. Laboratory cleanrooms often accommodate routine testing during normal operations while reserving comprehensive qualifications for scheduled downtime.
Shan International's experienced project managers coordinate testing schedules minimizing operational impact while ensuring comprehensive, compliant validation. We understand the unique challenges facing facilities across Saudi Arabia—from busy pharmaceutical production schedules to hospital operating room demands. Our flexible scheduling, efficient execution, and thorough planning maintain both production continuity and regulatory compliance for facilities throughout Riyadh, Jeddah, Dammam, and the Eastern Province.For pharmaceutical manufacturing areas, testing typically occurs during non-production periods with appropriate contamination control measures. Hospital operating rooms and critical care units can undergo testing during scheduled downtime between procedures. Laboratory and clean room environments often accommodate testing during normal operations with proper protocols.
However, some situations require temporary shutdown including initial commissioning tests, major system modifications, or when aerosol introduction poses unacceptable contamination risks. Our experienced project managers work closely with facility personnel to develop testing schedules that balance regulatory compliance needs with operational continuity.
Shan International's extensive experience testing facilities across Saudi Arabia—from active pharmaceutical manufacturing plants to busy hospital operating rooms—ensures minimal operational impact while delivering comprehensive, compliant filter integrity verification. We understand the unique challenges facing facilities in Riyadh, Jeddah, Dammam, and throughout the Kingdom, providing flexible scheduling and expert execution that maintains both production schedules and regulatory requirements.When filters fail testing, our certified technicians conduct detailed investigations to locate specific leak sources. Minor frame seal leaks sometimes respond to gasket adjustments or sealant application. However, media defects or significant seal failures require complete filter replacement to restore proper performance.
Shan International provides professional filter replacement services following NAFA (National Air Filtration Association) protocols. We safely remove contaminated filters, properly dispose of hazardous materials, install certified replacement units, and conduct integrity testing to verify leak-free performance. Our comprehensive approach minimizes facility downtime while ensuring regulatory compliance.
For pharmaceutical and healthcare facilities in Saudi Arabia, failed filters trigger deviation investigations, impact assessments, and potential product holds depending on severity and location. Our detailed documentation supports your quality management responses and regulatory reporting obligations. We also provide recommendations for preventing future failures through improved maintenance protocols or installation procedures across your facilities throughout the Kingdom.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
Why choose Shan International for cleanroom testing in Saudi Arabia?
Shan International offers unmatched cleanroom testing expertise throughout Saudi Arabia. Our NEBB Clean Room Testing (CRT) certification demonstrates mastery of ISO 14644 standards, proper testing methodologies, and comprehensive documentation requirements. We're the only NEBB-certified cleanroom testing contractor in the region, providing services unavailable from other Saudi companies.
Since 2008, we've successfully tested and certified hundreds of cleanrooms across pharmaceutical manufacturing facilities, hospital operating suites, bio-safety laboratories, and research institutions. Our client portfolio includes prestigious organizations like King Fahad Specialist Hospital, Saudi German Hospital, Gulf Farabi pharmaceutical facilities, KAUST research laboratories, and numerous GMP-certified manufacturers throughout the Kingdom.
We maintain Saudi Arabia's most comprehensive inventory of calibrated testing equipment including multiple laser particle counters, aerosol photometers, micromanometers, precision anemometers, environmental monitors, and specialized accessories. All instruments carry current calibration certificates traceable to international standards. Our ISO 9001:2015 and ISO 45001:2018 certifications ensure consistent quality and safety management..Since 2008, we've successfully tested thousands of filters across pharmaceutical manufacturing facilities, hospital operating rooms, bio-safety laboratories, and clean room environments. Our client portfolio includes prestigious organizations like King Fahad Specialist Hospital, Saudi German Hospital, Gulf Farabi, KAUST, and numerous GMP-certified pharmaceutical manufacturers throughout the Kingdom.
We hold ISO 9001:2015 and ISO 45001:2018 certifications ensuring consistent quality and safety management. Our registration with Saudi Aramco, SABIC, and other major organizations demonstrates our capability to meet the highest standards. We provide rapid response throughout Saudi Arabia with offices strategically located to serve Riyadh, Jeddah, Dammam, and the Eastern Province.
Our comprehensive service includes testing, filter replacement when needed, detailed documentation, and ongoing technical support. We understand Saudi regulatory requirements, international standards, and industry best practices—delivering certified excellence that protects your critical operations, ensures compliance, and maintains the trust you've built with regulators and customers throughout the Kingdom.For pharmaceutical manufacturing areas, testing typically occurs during non-production periods with appropriate contamination control measures. Hospital operating rooms and critical care units can undergo testing during scheduled downtime between procedures. Laboratory and clean room environments often accommodate testing during normal operations with proper protocols.
However, some situations require temporary shutdown including initial commissioning tests, major system modifications, or when aerosol introduction poses unacceptable contamination risks. Our experienced project managers work closely with facility personnel to develop testing schedules that balance regulatory compliance needs with operational continuity.
Shan International's extensive experience testing facilities across Saudi Arabia—from active pharmaceutical manufacturing plants to busy hospital operating rooms—ensures minimal operational impact while delivering comprehensive, compliant filter integrity verification. We understand the unique challenges facing facilities in Riyadh, Jeddah, Dammam, and throughout the Kingdom, providing flexible scheduling and expert execution that maintains both production schedules and regulatory requirements.When filters fail testing, our certified technicians conduct detailed investigations to locate specific leak sources. Minor frame seal leaks sometimes respond to gasket adjustments or sealant application. However, media defects or significant seal failures require complete filter replacement to restore proper performance.
Shan International provides professional filter replacement services following NAFA (National Air Filtration Association) protocols. We safely remove contaminated filters, properly dispose of hazardous materials, install certified replacement units, and conduct integrity testing to verify leak-free performance. Our comprehensive approach minimizes facility downtime while ensuring regulatory compliance.
For pharmaceutical and healthcare facilities in Saudi Arabia, failed filters trigger deviation investigations, impact assessments, and potential product holds depending on severity and location. Our detailed documentation supports your quality management responses and regulatory reporting obligations. We also provide recommendations for preventing future failures through improved maintenance protocols or installation procedures across your facilities throughout the Kingdom.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
Since 2008, we've successfully tested and certified hundreds of cleanrooms across pharmaceutical manufacturing facilities, hospital operating suites, bio-safety laboratories, and research institutions. Our client portfolio includes prestigious organizations like King Fahad Specialist Hospital, Saudi German Hospital, Gulf Farabi pharmaceutical facilities, KAUST research laboratories, and numerous GMP-certified manufacturers throughout the Kingdom.
We maintain Saudi Arabia's most comprehensive inventory of calibrated testing equipment including multiple laser particle counters, aerosol photometers, micromanometers, precision anemometers, environmental monitors, and specialized accessories. All instruments carry current calibration certificates traceable to international standards. Our ISO 9001:2015 and ISO 45001:2018 certifications ensure consistent quality and safety management..Since 2008, we've successfully tested thousands of filters across pharmaceutical manufacturing facilities, hospital operating rooms, bio-safety laboratories, and clean room environments. Our client portfolio includes prestigious organizations like King Fahad Specialist Hospital, Saudi German Hospital, Gulf Farabi, KAUST, and numerous GMP-certified pharmaceutical manufacturers throughout the Kingdom.
We hold ISO 9001:2015 and ISO 45001:2018 certifications ensuring consistent quality and safety management. Our registration with Saudi Aramco, SABIC, and other major organizations demonstrates our capability to meet the highest standards. We provide rapid response throughout Saudi Arabia with offices strategically located to serve Riyadh, Jeddah, Dammam, and the Eastern Province.
Our comprehensive service includes testing, filter replacement when needed, detailed documentation, and ongoing technical support. We understand Saudi regulatory requirements, international standards, and industry best practices—delivering certified excellence that protects your critical operations, ensures compliance, and maintains the trust you've built with regulators and customers throughout the Kingdom.For pharmaceutical manufacturing areas, testing typically occurs during non-production periods with appropriate contamination control measures. Hospital operating rooms and critical care units can undergo testing during scheduled downtime between procedures. Laboratory and clean room environments often accommodate testing during normal operations with proper protocols.
However, some situations require temporary shutdown including initial commissioning tests, major system modifications, or when aerosol introduction poses unacceptable contamination risks. Our experienced project managers work closely with facility personnel to develop testing schedules that balance regulatory compliance needs with operational continuity.
Shan International's extensive experience testing facilities across Saudi Arabia—from active pharmaceutical manufacturing plants to busy hospital operating rooms—ensures minimal operational impact while delivering comprehensive, compliant filter integrity verification. We understand the unique challenges facing facilities in Riyadh, Jeddah, Dammam, and throughout the Kingdom, providing flexible scheduling and expert execution that maintains both production schedules and regulatory requirements.When filters fail testing, our certified technicians conduct detailed investigations to locate specific leak sources. Minor frame seal leaks sometimes respond to gasket adjustments or sealant application. However, media defects or significant seal failures require complete filter replacement to restore proper performance.
Shan International provides professional filter replacement services following NAFA (National Air Filtration Association) protocols. We safely remove contaminated filters, properly dispose of hazardous materials, install certified replacement units, and conduct integrity testing to verify leak-free performance. Our comprehensive approach minimizes facility downtime while ensuring regulatory compliance.
For pharmaceutical and healthcare facilities in Saudi Arabia, failed filters trigger deviation investigations, impact assessments, and potential product holds depending on severity and location. Our detailed documentation supports your quality management responses and regulatory reporting obligations. We also provide recommendations for preventing future failures through improved maintenance protocols or installation procedures across your facilities throughout the Kingdom.Pharmaceutical facilities must meet EU-GMP Annex 1 requirements, which mandate filter integrity testing for sterile manufacturing environments. The Saudi Food and Drug Authority (SFDA) enforces compliance with these international GMP standards for all licensed pharmaceutical manufacturers in the Kingdom.
Healthcare facilities accredited by CBAHI must demonstrate proper filter maintenance and testing protocols. Facilities pursuing international accreditations like Joint Commission International (JCI) face additional documentation requirements.
Shan International maintains comprehensive knowledge of all applicable standards and regulatory requirements. Our NEBB certification ensures testing methodologies meet or exceed international benchmarks while satisfying Saudi regulatory authorities. We provide documentation packages that support regulatory submissions, validation protocols, and audit responses for facilities throughout Saudi Arabia.Discrete Particle Counter testing offers superior precision for ultra-clean environments like microelectronics manufacturing or advanced pharmaceutical aseptic processing. This method provides particle size distribution data and detailed contamination analysis meeting stringent documentation requirements.
Total Aerosol Penetration testing measures overall system efficiency, ideal for commissioning new installations or validating major modifications. Bench Scan testing verifies filter integrity before installation, preventing costly reinstallation of defective units.
For most Saudi Arabian pharmaceutical and healthcare facilities, Cold DOP testing using PAO aerosol provides optimal balance of accuracy, cost-effectiveness, and regulatory compliance. Shan International's NEBB certification ensures proper methodology selection and execution regardless of which testing approach your facility requires across Riyadh, Jeddah, or Dammam.
Featured Projects.
Shan International has successfully certified cleanrooms across Saudi Arabia’s most demanding pharmaceutical, healthcare, and research facilities. Our comprehensive testing portfolio demonstrates expertise in diverse applications and stringent requirements.
Notable projects include complete cleanroom qualification at Gulf Farabi pharmaceutical manufacturing facility in Jubail, hospital operating room and isolation unit certification at King Fahad Specialist Hospital Dammam and Saudi German Hospital Jeddah, bio-safety laboratory testing at Al-Hada Military Hospital Taif including BSL-3 containment validation, research laboratory cleanroom certification at KAUST, and multiple pharmaceutical aseptic processing suite qualifications throughout the Kingdom.
Testimonials
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We were very pleased with the service you all provided last time for the testing and balancing and the work and the Engineers were Certified, and they knew how to complete the work in required Time Duration. You will definitely have us as a repeat customer as soon as the opportunity comes up.
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I want to thank Shan International for Equipment Rental and HVAC solution Provider. From the outset the support and assistance I received was to notch. For me personally, the technical assistance and personal attention I received from Shan International was superb. They are always available to assist with any related issues, and was always extremely professional, patient, and gracious when resolving problems. I will certainly be recommending Shan International to my colleagues and peers. Thank you again for providing excellent service and support.
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Shan International (and the rest of team) are probably the most responsive I’ve ever worked with, especially when it comes to after hours and last-minute requests. You guys go above and beyond for me and I really do appreciate it! I recommend you guys to everyone. Installation rectification testing and Commissioning work are outstanding, and it was all supervised under a Certified Engineer. Thanks for all you do!!