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Why is having your hospital cleanroom certified important?

Why is having your hospital cleanroom certified important?

Cleanroom certification for a hospital is a process that verifies that specific spaces within the hospital meet particular cleanliness and environmental control standards. Cleanrooms in a hospital setting may be found in areas such as operating rooms, pharmacies (especially those compounding sterile preparations), and certain laboratories.

Cleanroom certification typically involves several tests performed by a qualified professional using specialized equipment. These tests may include:

  1. Airflow velocity and uniformity testing: This verifies that the air in the room is moving at the proper speed and in the right direction to remove particles from the area.

  2. Air pressure differential testing: Cleanrooms should maintain a higher pressure than adjacent areas to prevent the inflow of contaminated air.

  3. Particle count testing: This measures the number of airborne particles of various sizes in the cleanroom. This test is often carried out under various conditions, including at rest (no activity in the room) and in operation (normal working conditions).

  4. HEPA/ULPA filter integrity testing: High-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filters are used in cleanrooms to remove airborne particles. Integrity testing verifies that these filters are working correctly and are properly installed and sealed.

  5. Airflow visualization: This test, also known as a smoke study, visually demonstrates the airflow pattern inside the cleanroom. It helps in identifying potential problem areas where air turbulence or stagnation can occur.

  6. Temperature and humidity testing: These tests confirm that these conditions are maintained within the required limits.

  7. Lighting and noise level checks: These parameters are also monitored to ensure compliance with standards.

The cleanroom certification process is guided by various standards, such as those set forth by the ISO (International Organization for Standardization), specifically ISO 14644, or the USP (United States Pharmacopeia) for sterile compounding areas. Regular recertification is usually required to ensure ongoing compliance.

It's important to note that cleanroom certification should be part of a larger program of ongoing monitoring and maintenance to ensure a clean and safe environment in these critical areas.

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