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Ensuring Controlled Environments

Comprehensive Cleanroom Area Validation Services

Cleanroom area validation ensures compliance with international standards, safeguarding product integrity and operational efficiency.

Cleanroom area validation is a critical process in maintaining controlled environments, particularly for pharmaceutical and biotech applications. The procedure involves rigorous testing and calibration of cleanroom parameters, including airflow, particle count, and pressure differentials, to meet ISO and GMP standards. By ensuring these facilities operate within specified tolerances, validation protects against contamination, enhances product quality, and supports regulatory compliance. Containext Technologies offers tailored solutions using state-of-the-art equipment and expert methodologies to meet your specific requirements.

Features

Airflow Testing

Ensures laminar airflow meets ISO standards by measuring velocity and uniformity, preventing contamination in critical processing areas.

Particle Monitoring

Validates particle count levels using advanced equipment, ensuring compliance with ISO 14644-1 standards for a controlled cleanroom environment.

Pressure Control

Assesses and maintains differential pressure between rooms, safeguarding product and personnel by preventing cross-contamination.

Filter Integrity

Tests HEPA and ULPA filters for leaks or inefficiencies to maintain cleanroom classification and operational safety.

Temperature Stability

Monitors and validates consistent temperature control, essential for protecting sensitive processes and materials.

Regulatory Compliance

Adheres to GMP and ISO protocols, ensuring facilities meet international standards for quality and safety in cleanroom operations.

Contact Details

Germany (corporate office)
India (factory- headoffice)

    Containext Technologies specializes in advanced containment solutions for the pharmaceutical and healthcare industries. We offer customized isolators and containment systems that prioritize safety, compliance, and operational efficiency, ensuring a high standard of protection for both workers and environments.

    Office
    Germany (corporate office)
    India (factory- headoffice)
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