Pharma Engineering Validation (CQV)

In regulated industries like pharmaceuticals, biotechnology, and sterile manufacturing, validation ensures that facilities, systems, and equipment consistently operate within defined limits, delivering products that meet quality, safety, and regulatory requirements.

At SVU Enterprises, we provide comprehensive Pharma and engineering equipment’s commission, qualification and validation services that cover equipment, facilities, HVAC, and cleanroom environments — ensuring full compliance with cGMP, WHO, USFDA, EMA, and ISPE guidelines.

Equipment Qualification for API, OSD & Sterile Facilities

Pharmaceutical manufacturing equipment must undergo a structured qualification process to ensure it performs as intended and consistently produces quality output.

Our approach includes:

Design Qualification (DQ): Verifying that equipment design meets user and regulatory requirements.
Installation Qualification (IQ): Checking equipment installation against design drawings, utilities, and specifications.
Operational Qualification (OQ): Testing control systems, alarms, interlocks, operating ranges, and safety functions.
Performance Qualification (PQ): Demonstrating consistent performance under real production conditions.

We handle qualifications for a wide range of equipment, including:

Reactors, centrifuges, dryers, granulators, coating machines, autoclaves, lyophilizers, and cold storage chambers.

API, OSD (Oral Solid Dosage), and sterile facility equipment with full lifecycle documentation.

HVAC & Facility Qualification

HVAC systems are the backbone of controlled environments in pharma and biotech facilities. Any deviation can compromise cleanroom classification, product quality, and patient safety.

Our services include:

Air Handling Unit (AHU) Qualification – airflow patterns, differential pressures, HEPA filter integrity testing, recovery rates.
Facility Qualification – ensuring layouts, material/personnel flows, and utilities meet regulatory standards.
Temperature & Humidity Mapping – using calibrated sensors and data loggers for controlled environments, cold rooms, warehouses.
Differential Pressure Monitoring – across cleanrooms to prevent cross-contamination.

All tests are documented in line with ISO 14644, ISPE, and WHO TRS standards for cleanroom classification and facility validation.

HVAC & Facility Qualification

HVAC systems are the backbone of controlled environments in pharma and biotech facilities. Any deviation can compromise cleanroom classification, product quality, and patient safety.

Our services include:

Air Handling Unit (AHU) Qualification – airflow patterns, differential pressures, HEPA filter integrity testing, recovery rates.
Facility Qualification – ensuring layouts, material/personnel flows, and utilities meet regulatory standards.
Temperature & Humidity Mapping – using calibrated sensors and data loggers for controlled environments, cold rooms, warehouses.
Differential Pressure Monitoring – across cleanrooms to prevent cross-contamination.

All tests are documented in line with ISO 14644, ISPE, and WHO TRS standards for cleanroom classification and facility validation.

Cleanroom Validation & Compliance Documentation

Cleanrooms are critical for sterile product manufacturing, where contamination control is essential. We provide:

Particle Count Testing (as per ISO 14644-1)
Microbial Monitoring (settle plates, contact plates, active air sampling)
Airflow Visualization (Smoke Studies) – ensuring unidirectional airflow and identifying turbulence.
HEPA Filter Integrity Testing – DOP/PAO testing to verify filter sealing and efficiency.
Cleanroom Qualification Protocols & Reports – fully compliant with regulatory standards.

Our documentation is audit-ready, supporting regulatory inspections by USFDA, MHRA, EMA, and CDSCO.

Calibration & Verification Support

Accurate measurement is essential for validation and compliance. SVU Enterprises provides calibration and verification services for critical instruments and utilities, including:

Temperature, humidity, pressure, and differential pressure sensors
Flow meters, conductivity & pH sensors
Level transmitters, weighing balances, and analytical instruments

We ensure all instruments are calibrated with traceability to national/international standards (NABL, NIST) and maintain calibration records as per GxP requirements.