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Detailed Requirements for Surgical Cleanrooms
Surgical cleanrooms are critical environments designed to minimize the risk of infections and ensure the safety of patients during medical procedures. Here are the detailed requirements for maintaining a surgical cleanroom:
Air Quality and Ventilation
- HEPA Filters: High-Efficiency Particulate Air (HEPA) filters must be used to remove 99.97% of airborne particles larger than 0.3 microns.
- Air Changes: The cleanroom should have a minimum of 20 air changes per hour to maintain sterility.
- Positive Pressure: The room must maintain positive air pressure relative to adjacent areas to prevent contaminated air from entering.
Temperature and Humidity Control
- Temperature: Maintain a consistent temperature between 20°C to 24°C (68°F to 75°F) for optimal comfort and equipment performance.
- Humidity: Relative humidity should be kept between 30% to 60% to prevent microbial growth and static electricity.
Surface and Material Requirements
- Non-Porous Surfaces: All surfaces should be smooth, non-porous, and easy to clean to prevent bacterial accumulation.
- Antimicrobial Materials: Use antimicrobial coatings or materials where possible to reduce the risk of contamination.
Lighting
- Brightness: Adequate lighting (at least 1,000 lux) is essential for visibility during surgeries.
- Shadow-Free: Lighting should be shadow-free and evenly distributed to avoid creating blind spots.
Personnel and Garments
- Protective Clothing: All personnel must wear sterile gowns, gloves, masks, and caps to minimize contamination.
- Training: Staff should be trained in cleanroom protocols and hygiene practices.
Equipment and Instruments
- Sterilization: All surgical instruments must be sterilized before use and stored in a sterile environment.
- Minimal Equipment: Only essential equipment should be present to reduce clutter and contamination risks.
Cleaning and Disinfection
- Routine Cleaning: The cleanroom should be cleaned and disinfected before and after every procedure.
- Validated Disinfectants: Use EPA-approved disinfectants effective against a broad spectrum of pathogens.
Monitoring and Compliance
- Particle Counts: Regularly monitor airborne particle counts to ensure compliance with ISO Class 5 or higher standards.
- Documentation: Maintain detailed records of cleaning, maintenance, and air quality testing.
By adhering to these requirements, surgical cleanrooms can provide a safe and sterile environment for patients and medical professionals alike.
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