STRIVINGENGINEERINGIN CLEANROOM

Clean Room HVAC Validation

Cleanroom HVAC validation is a critical process in pharmaceutical industries to demonstrate that air handling systems consistently deliver controlled temperature, humidity, air velocity, and cleanliness levels. In alignment with ISO 14644 and EU GMP Annex 1.

Validation ensures that cleanrooms achieve and maintain the required classification, protecting product integrity and patient safety.

• Air Velocity & Airflow Pattern Testing
• Differential Pressure Testing
• HEPA Filter Integrity Testing (Leak Test)
• Cleanroom Classification (Particle Count Test)
• Temperature & Humidity Mapping

Thermal Validation

Thermal validation in pharmaceutical cleanrooms is a critical process that ensures controlled environments, equipment, and processes maintain consistent and uniform temperature distribution. This validation is essential for maintaining product quality, safety and meeting international guidelines including WHO, EU GMP, FDA, and ISO standards.

• Cleanroom Temperature & RH Mapping
• Temperature Distribution Analysis
• Equipment Thermal Mapping
• Process Validation Studies
• Cold Chain Validation

NABL Calibration Laboratories

Our NABL-accredited laboratory delivers precise calibration services backed by traceable standards. We specialize in thermal, electrical, pressure, and airflow parameters, ensuring pharmaceutical and biotech companies meet stringent compliance requirements. With robust documentation and state-of-the-art instruments, our services guarantee accuracy, reliability, and regulatory readiness.

• Thermal Calibration – Temperature sensors, thermocouples, RTDs.
• Electro-Technical Calibration (ET) – Multimeters, data loggers, transmitters.
• Pressure Calibration – Gauges, transmitters, manometers.
• Airflow & Velocity Calibration – Anemometers, airflow meters.
• Humidity Calibration – Sensors and data loggers for RH mapping.

Onsite Instrument Calibration (Powered by CAALDOCK™)

Our CAALDOCK™ software-driven onsite calibration is a unique USP, designed specifically for pharmaceutical environments. It ensures real-time, paperless, and compliant calibration at customer sites, reducing downtime while maintaining regulatory integrity.

• Thermal Instruments – RTDs, thermocouples, sensors.
• Electro-Technical Devices – Transmitters, controllers, multimeters
• Pressure Instruments – Differential, vacuum, and gauge pressure devices.
• Airflow Testing Devices – Anemometers, Airflow Sensors
• Data Integrity & Reporting – 21 CFR Part 11 compliant digital records via CAALDOCK™.

Process & Validation

We provide complete process validation services with detailed documentation and compliance support, ensuring equipment, systems, and processes meet regulatory expectations for consistent performance.

• Process Qualification (PQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Validation Documentation

Cleanroom Design & Installation

We provide turnkey cleanroom solutions from design to commissioning, ensuring controlled environments that comply with international regulatory standards. Our services combine engineering expertise, HVAC integration, and qualification support tailored for pharmaceutical and biotech industries.

• Cleanroom Design & Engineering – Customized layouts meeting ISO 14644 and EU GMP standards.
• HVAC System Installation – High-performance AHUs, ducting, and filtration systems.
• Cleanroom Infrastructure – Modular walls, ceilings, flooring, and utility integration.
• Commissioning & Qualification – Comprehensive IQ, OQ, PQ protocols.
• Regulatory Compliance Assurance – Documentation aligned with EU GMP Annex 1 and FDA guidelines.