Environmental safety in the hospital and healthcare environment is paramount and managing the facilities and equipment that help protect workers and patients is critical.

QV Test’s comprehensive cleanroom and controlled environment testing and certification services coupled with our technical expertise and regulatory knowledge will ensure your critical environments are in compliance with standard and regulation.

• Cleanroom Testing and Certification 
  1. Operating Room (OR): The safe surgery saves lives. As patients in the operating room are easy to be infected by the ex ternal environment, so high cleanliness level in operating room is a must.
  2. Patient Isolation Room/Negative Pressure Room: The room for infection control; normally it will be focused on airflow volume measurement and differential air pressure measurement.
  3. Cardiac Catheterization Lab (Cath Lab): If the lab is performing permanent pacemaker insertions or some of the more advanced percutaneous aortic repair procedures in this setting, ventilation and airflow must meet operating room standards.
  4. Intensive Care Unit (ICU): A designated area of a hospital facility that is dedicated to the care of patients who are seriouslyill. Highly infective or particularly vulnerable cases (e.g. patients with burns, immune deficiency) are generally admitted in the ventilated room using reversible positive/negative airflow, with at least 15 air changes/hour.

  To show that a cleanroom is working satisfactorily, it is necessary to demonstrate that the following principles have been satisfied :

  • ‐ The air supplied to the cleanroom is of sufficient quantity to dilute or remove the contamination generated in the room.
  • ‐ The air supplied to the cleanroom is of a quality that will not add significantly to the contamination within the room.
  • ‐ The air within the cleanroom suite moves from clean to less‐clean areas to minimize the undesirable movement of contaminated air. Air should move in the correct direction through doorways and the construction fabrics of the room.
  • ‐ The air movement within the cleanroom should ensure that there are no areas within the room with high concentrations of contamination.

  QV Test offer service includes :
  Primary Tests are related to airborne particulate cleanliness class as required by ISO 14644. By performing these tests, the cleanroom will be correctly classified to the appropriate class level

  • - Airflow Velocity and Uniformity Tests
  • - Airflow Volume and Uniformity Tests
  • - Air Change Rate (ACH) Tests
  • - HEPA Filter Installation Leak Tests
  • - Airborne Particle Count Cleanliness Classification Tests
  • - Room Pressurization Test

  Secondary Tests are user optional and relate to particle, air movement, and ancillary systems within the cleanroom

  • - Airflow Smoke Pattern Tests
  • - Recovery Tests
  • - Lighting Level and Uniformity Tests
  • - Temperature and Humidity Uniformity Tests
  • - Air Change Rate (ACH) Tests
• HVAC System: Air Handling Unit (AHU) Testing and Certification

  The heating, ventilation and air conditioning (HVAC) system that supports Cleanrooms must be verified. QV test offers the test includes :

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Magnehelic Gauge Verification
• Environmental Control Unit Testing: Warehouse, Refrigerator/Freezer

  Temperature and humidity are important factors in the stability of pharmaceutical products. Temperature sensitive medi- cines/vaccines can degrade at higher temperature. Therefore, it is important to ensure that the temperature and humidity level in the storage areas could be maintained within the desired requirements.

  QV test offers service includes :

  - Temperature Mapping Studies / Temperature & Humidity Mapping Studies.

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Equipment Qualification

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• Laminar Airflow Unit

  Laminar airflow unit is an area that is controlled the airflow pattern to be laminar, as it is highly likely that with unidirectional airflow could lower the risk of contamination in orderly pattern. Conversely, turbulent air flow pattern could not be controlled, resulting to have high risk of contamination.

  

  The procedure of validation will be the same as individual cleanroom consists of :

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Airborne Particle Count Cleanliness Classification Tests
  • - Differential Pressure and Magnehelic Gauge Reading
  • - Airflow Smoke Pattern Tests

  Normally, Laminar cabinet cleanliness class is “A” or class 100.

• Bio Safety Cabinet (BSC)

  There are three types of BSC, class I, II and III to protect the operators to be affected by the contamination. QV test conducts the test by referring to GMP standard.

  Test parameters

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Airborne Particle Count Cleanliness Classification Tests
  • - Differential Pressure and Magnehelic Gauge Reading
  • - Airflow Smoke Pattern Tests
  • - Lighting Level and Uniformity Tests
  • - Ultraviolet light measurement