VALIDATION & QUALITY ASSURANCE
Drawing on deep technical knowledge and broad experience in designing and building cleanrooms, KGS provides specialist validation services covering design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), so that every facility and process operates to the most rigorous international standards and regulatory requirements.
Before any construction begins, the system design is assessed in detail. Fluid-dynamics simulation tools such as ANSYS Fluent identify and analyse airflow patterns, dead zones and areas prone to contamination build-up, minimising the technical risks of later stages.
Confirms through document review and site inspection that equipment and systems have been installed according to the design specifications and the manufacturer's requirements.
System performance is tested and verified across the defined operating ranges, proving it can carry out its functions under different conditions.
The final stage: system performance is evaluated under real operating conditions and over the long term, demonstrating that it meets the requirements and standards consistently and reliably.
KGS is rooted in a knowledge-based approach: deep technical expertise, continuous research and innovation form the backbone of its services. The company has particular expertise in analysing and visualising airflow in controlled environments, using advanced CFD modelling and tools such as ANSYS Fluent to identify complex airflow patterns, dead zones and areas prone to contamination build-up.
Mastery of the key standards ISO 14644 (cleanrooms and controlled environments) and GMP (pharmaceutical and healthcare industries) ensures that every validation and quality-assurance process meets the latest international requirements. The company operates under the supervision of the National Accreditation Center of Iran (NACI) and holds ISO/IEC 17025 accreditation for testing and calibration laboratories.
Knowledge-based companies that use KGS validation and quality-assurance services can, within the applicable rules and regulations, also benefit from government support and incentives covering qualification and validation costs.
A wide range of industries and organisations rely on KGS specialist services; every solution is tailored to the specific needs and requirements of the client.
Manufacturers of oral and injectable medicines that need the highest level of cleanliness and environmental control.
Medical-device manufacturers whose production environment must be free of contamination and airborne particles.
Especially semiconductor and sensitive-component manufacturing, which requires ultra-clean environments.
Where precise environmental control is essential for valid, repeatable results.
Especially operating theatres, sterilisation departments and on-site pharmacy production.
Every process follows ISO 14644 and GMP using a precise, documented and traceable method, ensuring regulatory compliance, audit readiness and long-term confidence.
Tests are performed with advanced, calibrated European and American instruments within an accredited quality framework (NACI and ISO/IEC 17025).
Compliance with technical and regulatory requirements is monitored at every stage, and effective corrective and preventive actions are provided for every non-conformance.
Tell us your requirements, the standard you work to and the capacity you need; the KGS engineering team will walk through the proposed approach with you.