Clean room validation

How do we clean the room and validate it?

Qualitas is the first and only laboratory accredited with ISO 17025 for full Clean room test parameters form Emirates National Accreditation Services (ENAS).  Qualitas Testing Laboratories provides a complete clean room testing, monitoring and validation services for Hospitals and Pharmaceutical clean room areas and our certificates are approved by Dubai Health Authority (DHA), Health Authority of Abu Dhabi (HAAD and Abu Dhabi Health Services (SEHA).

CLEAN ROOM TESTING CAPABILITY:

  • Airflow volume/velocity profiling
  • (Airflow visualization testing) Smoke Testing
  • Viable environmental monitoring (Microbial Airborne test)
  • Room air exchange rates
  • HEPA filter integrity testing
  • Non-viable particulate monitoring (PM.05, PM 1.0)
  • Differential Pressure
  • Sound testing
  • Light testing
  • Temperature and humidity monitoring

Regulatory Guidance / Test Methods:

  • FDA: Guidance for Industry Sterile Drug Produced by Aseptic Processing
  • FDA:  Quality System Regulation: Medical Device
  • ISO 14644
  • ISO 14698

    Welcome to Qualitas Qualitas Laboratories was set up in Abu Dhabi on 20th January 2013. The company’s mission is to provide independently accredited materials testing services to the very highest standards of quality, service and technical compliance. Fully qualified and experienced personnel are available to design and implement inspection and testing programs tailored to clients’ individual investigative requirements.

    ADDRESS

    Qualitas Material Testing Laboratories Store-7&8, Plot No-21,
    Block-C Mussafah-15, Abu Dhabi, UAE, P.O.Box: 9035.

    PHONE

    +971 2 555 2928

    EMAIL

    info@qualitasme.com