Grintech

Who We Serve

• Pharmaceuticals and Biotech – Sterile manufacturing and aseptic processing facilities.
• Medical Device Industry – Assembly, packaging, and sterile barrier manufacturing environments.
• Semiconductor and Microelectronics – Wafer fabrication, precision assembly, and contamination-controlled production.
• Aerospace and Defense – Precision manufacturing and contamination-sensitive processes.
• Food and Beverage – High hygiene production and processing areas.
• Research Laboratories – R&D cleanrooms and ISO-classified laboratory environments.
• Hospitals and Healthcare Facilities – Operating rooms, ICUs, and other sterile environments requiring certification.
• Electronics Industry – Semiconductor and microchip manufacturing cleanrooms requiring stringent contamination control.

Standards and Guidance We Follow

• Grintech performs testing and certification in accordance with internationally recognized standards and regulatory guidance.
• ISO 14644 Cleanroom Standards for cleanroom classification and testing methods.
• EU GMP Annex 1 guidance for sterile manufacturing environments.
• IEST Recommended Practices for cleanroom testing and certification.
• Industry accepted procedures for airborne particle monitoring, airflow testing, filtration performance, and environmental monitoring.
• Testing methods that provide accurate, repeatable, and auditable certification results for regulatory compliance.

Core Cleanroom Testing & Certification Services

• Cleanroom Classification (ISO 14644-1) using airborne particle count measurements at specified sampling locations.
• Non-Viable Particle Monitoring through continuous and periodic monitoring programs.
• Viable (Microbiological) Monitoring using active air sampling, settle plates, and surface contact sampling.
• Airflow and Pressure Differential Testing to verify room pressurization and directional airflow.
• HEPA and ULPA Filter Integrity Testing using aerosol challenge methods to verify filter performance.
• Air Change Rate (ACH) and Recovery Testing to validate ventilation performance.
• Smoke Visualization and Airflow Mapping to confirm airflow patterns and identify dead zones.
• Cleanroom Gowning and Personnel Qualification Audits to minimize human-generated contamination.
• Environmental Monitoring Program Design and Validation tailored to process risk and regulatory requirements.
• Clean Compressed Gas and Nitrogen Testing based on ISO 8573-1 standards.
• Commissioning, Qualification, and Re-Certification packages supporting project handover and ongoing compliance.
• Troubleshooting and Remediation Support for contamination events, failed test points, and corrective action verification.

Typical Deliverables

• Formal Cleanroom Classification Certificate and comprehensive test report with ISO classification, sampling locations, and measured results.
• Detailed reports covering airborne particle counts, viable monitoring, airflow measurements, pressure differentials, and HEPA/ULPA filter integrity testing.
• Raw test data with pass/fail evaluation against customer acceptance criteria and applicable industry standards.
• Trend analysis with practical recommendations to improve environmental monitoring programs and cleanroom performance.
• Commissioning, qualification, validation, and re-certification documentation suitable for regulatory submissions and customer audits.

Why Choose Grintech

• Standards-Based Testing – All testing is performed using internationally recognized ISO 14644 methods and accepted industry best practices.
• Cross-Industry Expertise – Extensive experience supporting pharmaceutical, biotechnology, medical device, semiconductor, aerospace, electronics, research, healthcare, and food manufacturing industries.
• Traceable Instrumentation – Calibrated particle counters, manometers, airflow measurement devices, and microbiological sampling equipment ensure reliable and repeatable results.
• Comprehensive Reporting – Clear, well-structured reports designed for engineering teams, quality assurance departments, procurement professionals, and regulatory auditors.
• End-to-End Support – From cleanroom design review and commissioning through periodic surveillance, troubleshooting, remediation, and re-certification, Grintech remains your trusted technical partner.

Get Started

Whether you require a new cleanroom classification, routine environmental monitoring, HEPA filter integrity testing, airflow visualization, compressed gas testing, or a complete commissioning and qualification package, Grintech is ready to help. Our experienced engineers provide tailored testing programs designed around your facility, production process, and regulatory requirements. Contact us at info@grintechgroup.com to discuss your project and receive a customized scope of work and quotation.