Hospital Operating Rooms

Validation of Surgical Rooms in Hospitals

The Core competence of the validation department is to qualify and maintain your Operating Theatre Complex and other critical rooms like the CSA within an hospital.
Leak testing of HEPA filters
Filter integrity test according to ISO 14644-3
Independent Company
We work as a fully independent company and we can also qualify your laminar flow cabinets and microbiological safety cabinets.  To requalify an operating theatre we start to prepare the validation protocols and use the available standards as a reference. There are several important tests to perform, usually the tests are performed in the at-rest situation. The HEPA filters in a cleanroom or operating theatre must be in optimal condition, we therefore check the HEPA filter integrity (efficiency), air velocity and pressure drop.
The results of these tests give us important information about the performance of the HEPA filters. If the test was succesfull we continue with the classification of the room based on the airborne particle concentrations according to ISO14644-1:2015 followed by other tests like airflow visualisation studies and airflow measurements to calculate the airchange. In the event of a failure on the filter efficiency we try to repair the filter or replace the filter so we can immediately test the filters again before we proceed to the other measurements.
VCCN Guidelines for Validation of Surgical Rooms
CMI is a member of the VCCN (Vereniging Contamination Control Nederland) and the association has published an important standard to test the surgical room in a (semi)-operational state. This standard is referenced as the VCCN RL7. With this standard we simulate a semi-operational state of the surgical room by inserting a challenge contamination from the periphery area and see how far this contamination penetrates into the clean area below the HEPA filter plenum with Unidirectional Flow (UDF). The validation conform to VCCN guideline RL-7 for both class 1 and class 2 performance level results in a protected area which is indicated on the floor of the operating room.
Cleanroom Management International - Hospital Operating Rooms
Operating Theatre
RL7 measurement in progress
Cleanroom Management International - Hospital Operating Rooms
Determination of the protected area
The validation report contains following data…
  • particle counts with a particle counter
  • protection level (only for performance level 1)
  • recovery time
  • integrity testing of the HEPA filters
  • measurement of air velocities
  • differential pressure measurements
  • temperature measurement of the two or three zones (Z1,Z2 and Z3 in applicable)
All measurements comply with VCCN RL7, ISO 14644-1:2015, ISO 14644-3 and HGR
Cleanroom Management International - Hospital Operating Rooms
Validation services for Hospitals
  • Cleanroom Validation
  • Validation of Laminar Flow Cabinets
  • Validation of Microbiological Safety Cabinets
  • Validation of Weighing Enclosures
  • Filter integrity testing
  • Particle counting
  • Flow Visualisation studies
  • Noise levels and Light Intensity
  • Microbiological sampling
  • VCCN RL7 measurements
  • VCCN RL8 Measurements
Cleanroom Management International - Hospital Operating Rooms
Execution and reporting
All measurements are carried out by well trained and educated engineers with state of the art validation equipment. All engineers have a VCA certificate and extensive experience within the healthcare and pharmaceutical industry. They are trained on the equipment they use and on the reporting requirements according to GDocP.
The raw data of the measurements and a provisional conclusion is handed over directly after the last day of the measurements to release the room on short notice for surgery. The final report is verified within CMI by our own Quality Department after which the final report is send. The report includes all raw data, calibration certificates of the equipment used and conclusions / recommendations based on the results of the measurements.
Cleanroom Management International - Thermal Validation
Good Documentation Practices
Reports are verified by QA department