# Services

> Ahmedabad-based GMP consulting: cleanroom and equipment qualification, CSV, contamination control, mock audits, training and sterile lab consumables.

Canonical: https://steriqualsolutions.com/services

## Pharmaceutical GMP & Investigation Services

Comprehensive compliance, risk management and validation frameworks for sterile and non-sterile drug manufacturing facilities.

- **Contamination Control Strategy (CCS)**: End-to-end design, gap analysis and execution aligned with current international mandates.
- **Microbial failure investigations**: Deep-dive root-cause identification for environmental monitoring (EM) excursions, deviations, operational failures and out-of-specification (OOS) results.
- **Aseptic Processing Simulation (APS) troubleshooting**: Specialized intervention, analysis and robust remediation plans for media fill failures.
- **Water system & area qualification**: Meticulous qualification protocols for Purified Water (PW), Water for Injection (WFI), clean utilities and HVAC systems.
- **Equipment qualification including CSV**: Qualification of equipment, including Computer Systems Validation (CSV).
- **Mock auditing & regulatory readiness**: Comprehensive pre-inspection plant assessments to prepare for successful audits by global regulatory bodies.
- **SOP & study protocol preparation**: Clear, technically sound and fully compliant laboratory procedures and execution scripts.
- **QC microbiology training**: Specialized training structures that reduce laboratory subjectivity and human error.

Our validation and consulting services are aligned with international standards such as ISO, USFDA, EMA, PIC/S and the Indian Drugs and Cosmetics Act.

## Precision Cleanroom Qualification & Testing

Advanced environmental monitoring, structural integrity assessments and particle dynamic testing, tailored to meet stringent semiconductor manufacturing standards.

- **Airborne particle count** (ISO 14644-1): Measures suspended air particles with calibrated counters to verify the target cleanliness class.
- **Airflow velocity & volume** (ISO 14644-3): Measures filter face velocities and volumetric flow rates to confirm uniform air distribution and exchange rates.
- **Air pressure differential** (ISO 14644-3): Verifies positive pressure cascades and their stability across cleanroom boundaries to prevent contaminant ingress.
- **Filter integrity (HEPA/ULPA leak test)** (ISO 14644-3): Uses an upstream aerosol challenge to scan for media bypass, framing and gasket leaks.
- **Airflow direction & visualization** (ISO 14644-3): Maps air currents over critical surfaces with visual tracers to confirm clean, non-turbulent streamlines.
- **Temperature & humidity** (ISO 14644-3): Tracks room climate stability to prevent electrostatic and material risks.
- **Recovery test** (ISO 14644-3): Benchmarks how quickly the room flushes out a particle spike and returns to baseline cleanliness.
- **Containment leak test** (ISO 14644-3): Checks structural joints and ceiling panels for air leakage that lets ambient particles in.

## Laboratory Consumables and Equipment

Supply of high-calibre sterile and depyrogenated consumables, and laboratory testing instruments tailored for pharmaceutical QC environments.

- **Supply of consumables**: Reliable distribution of premium sterile, non-sterile and depyrogenated microbiological consumables. All consumables meet the applicable regulatory requirements.
- **Equipment supply and custom design**: Sourcing, supply and custom engineering of specialized pharmaceutical QC laboratory instruments, built around your exact requirements.

Request any service: https://steriqualsolutions.com/contact-us