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Validation & Certification
At Soultrix TPL Services, our Validation & Certification Services ensure that your critical environments and systems meet the highest standards of quality, performance, and regulatory compliance. Whether it’s a cleanroom, HVAC system, or utility network, we provide detailed validation protocols and third-party certifications that guarantee your facility is audit-ready and fully operational.
Our Core Expertise Includes
- HVAC System Validation
We provide comprehensive HVAC system validation services to ensure systems perform as per design intent and meet stringent ISO, WHO, and GMP guidelines. Our validation approach focuses on verifying air quality, system performance, and compliance for controlled environments.
Our services include:
- Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Air Handling Unit (AHU) Performance Testing
- Airflow Visualization (Smoke Studies)
- Air Change Rate (ACPH) Measurement and Validation
- HEPA Filter Integrity Testing (PAO/DOP Test)
- Differential Pressure (DP) Monitoring and Validation
- Temperature & Relative Humidity Mapping
- Duct Leakage Testing and Air Balancing (TAB)
- Cleanroom Classification as per ISO 14644 Standards
- Preparation of Validation Protocols and Reports
Our validation ensures compliance, consistent environmental control, product safety, and audit readiness for pharmaceutical, healthcare, semiconductor, and other critical facilities.
- Cleanroom Validation
We provide comprehensive cleanroom validation services for environments ranging from Class 100 to Class 100,000 (ISO 5 to ISO 8), ensuring compliance with ISO 14644, GMP, and regulatory standards. Our validation process verifies cleanliness, airflow performance, and environmental control for critical applications.
Our services include:
- Cleanroom Classification (Particle Count Testing)
- Airflow Visualization (Smoke Studies)
- Air Change Rate (ACPH) Measurement
- HEPA Filter Integrity Testing (PAO/DOP Test)
- Recovery Rate Testing
- Differential Pressure (DP) Verification
- Temperature & Relative Humidity Mapping
- Air Velocity and Uniformity Testing
- Containment Leakage and Integrity Testing
- Preparation of Validation Protocols and Detailed Reports
Our validation ensures consistent cleanroom performance, regulatory compliance, contamination control, and audit readiness for pharmaceutical, healthcare, semiconductor, and high-precision manufacturing facilities.
- HEPA Filter Integrity Testing
We provide specialized HEPA filter integrity testing services using DOP/PAO methods to ensure proper filtration performance and eliminate contamination risks in critical environments. Our testing procedures are aligned with ISO 14644, GMP, and international cleanroom standards.
Our services include:
- DOP/PAO Aerosol Leak Testing for HEPA & ULPA Filters
- Scanning of Filter Face, Frame, and Seals for Leakage Detection
- Verification of Filter Installation and Sealing Integrity
- Testing of Terminal HEPA Units and Filter Housings
- Calibration of Aerosol Generators and Photometers
- Documentation of Test Results with Acceptance Criteria
- Identification and Rectification Support for Leak Points
- Compliance with Regulatory and Audit Requirements
Our testing ensures zero leakage, optimal filtration efficiency, contamination control, and reliable cleanroom performance for pharmaceutical, healthcare, semiconductor, and critical manufacturing facilities.
- Temperature & Humidity Mapping
We provide comprehensive temperature and humidity mapping services to ensure consistent environmental conditions across HVAC zones, storage areas, and production spaces. Our solutions support regulatory compliance, product safety, and process reliability in controlled environments.
Our services include:
- Real-Time Temperature & RH Data Logging and Monitoring
- Mapping of HVAC Zones, Warehouses, and Cleanrooms
- Seasonal Mapping (Summer/Winter Qualification Studies)
- Identification of Hot Spots and Cold Spots
- Calibration of Sensors and Data Loggers
- Compliance with GMP, WHO, and Regulatory Guidelines
- Data Analysis with Graphical Reports and Trends
- Preparation of Mapping Protocols and Validation Reports
- Support for Audit and Regulatory Inspections
Our mapping ensures uniform environmental control, compliance with standards, reduced product risk, and reliable HVAC system performance across pharmaceutical, healthcare, semiconductor, and industrial facilities.
- Airflow & Pressure Differential Testing
We provide comprehensive airflow and pressure differential testing services to validate system performance and ensure compliance with regulatory and design requirements for controlled environments. Our testing ensures proper airflow patterns, containment, and pressurization for critical applications.
Our services include:
- Air Velocity Measurement and Airflow Volume Testing
- Laminar Airflow (LAF) Validation and Uniformity Checks
- Directional Airflow Verification between Rooms/Zones
- Room Pressurization and Differential Pressure (DP) Testing
- Air Change Rate (ACPH) Calculation and Verification
- Balancing of Supply, Return, and Exhaust Air Systems (TAB)
- Identification of Airflow Imbalances and Leakages
- Compliance with ISO 14644, GMP, and WHO Guidelines
- Detailed Test Reports with Observations and Recommendations
Our testing ensures proper contamination control, stable pressure cascades, regulatory compliance, and reliable HVAC performance in pharmaceutical, healthcare, semiconductor, and cleanroom facilities.
- Utility Qualification (IQ / OQ / PQ)
We provide comprehensive utility qualification services to ensure critical systems perform reliably and meet GMP, WHO, and regulatory requirements. Our structured approach covers Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for various utility systems.
Our services include:
- Preparation of Qualification Protocols (IQ, OQ, PQ)
- Installation Qualification (IQ) for System Verification
- Operational Qualification (OQ) for Functional Performance Testing
- Performance Qualification (PQ) under Actual Operating Conditions
- Qualification of Compressed Air, Chilled Water, and Vacuum Systems
- Testing of Process Utilities and Distribution Networks
- Calibration of Instruments and Sensors
- Documentation, Data Recording, and Validation Reports
- Support for Regulatory Audits and Compliance
Our qualification services ensure system reliability, consistent performance, regulatory compliance, and audit readiness for pharmaceutical, healthcare, semiconductor, and industrial facilities.
- Documentation & Certification
We provide comprehensive documentation and certification services to support validation, compliance, and regulatory approvals for critical systems and facilities. Our deliverables are aligned with FDA, GMP, ISO, and NABL guidelines, ensuring complete transparency and audit readiness.
Our services include:
- Preparation of Validation Protocols (IQ, OQ, PQ)
- Detailed Validation and Summary Reports
- Standard Operating Procedures (SOPs) and Documentation Sets
- Third-Party Testing and Certification Coordination
- Calibration Certificates and Test Reports
- Compliance Documentation as per FDA, GMP, ISO, NABL Standards
- Audit Support and Documentation Review
- Compilation of Final Validation Dossiers
- Support for Regulatory Inspections and Approvals
Our structured documentation ensures full compliance, traceability, accurate reporting, and smooth certification processes, enabling clients to meet regulatory requirements with confidence.