Cytotoxic drugs, commonly used in chemotherapy, are hazardous substances that require strict control during preparation to protect both healthcare workers and patients. A cytotoxic (clean) room is a specialized area designed to safely prepare these medications under sterile and contamination-free conditions.
Purpose of a Cytotoxic room has objectives are to:
- Protect personnel from exposure to toxic substances.
- Ensure aseptic preparation of chemotherapy drugs.
- Maintain environmental safety for the facility.
- Prevent contamination of the drugs with microorganisms or particles.
A cytotoxic room should follow ISO Class 7 or better standards and be equipped with:
- HEPA filtration system for maintaining air purity and pressure differentials (positive pressure for clean zones, negative pressure for hazardous zones).
- Laminar Airflow Cabinet (LAF) or Biological Safety Cabinet (Class II, Type B2) for aseptic compounding.
- Separate anteroom for gowning and material transfer.
- Smooth, non-porous surfaces for easy cleaning and disinfection.
- Clearly marked work zones to separate “dirty” and “clean” activities.
Personnel are the most common source of contamination. Some proper procedures, include:
- Wearing personal protective equipment (PPE) such as gowns, gloves, masks, hair covers, and shoe covers.
- Performing hand hygiene before and after any activity.
- Avoiding unnecessary movement and talking inside the clean area.
- Receiving specialized training in aseptic techniques and cytotoxic handling.
Environmental Cleaning and Maintenance with routine cleaning is crucial to maintaining a sterile environment:
- Use validated disinfectants effective against bacteria, fungi, and spores.
- Ensure airflow and pressure differentials are checked and recorded regularly.
- Clean work surfaces before and after each preparation with 70% isopropyl alcohol.
- Conduct daily, weekly, and monthly cleaning schedules for all equipment, walls, floors, and ceilings.
- Use spill kits for immediate decontamination of cytotoxic spills.
For Waste Management, all of cytotoxic waste must be handled separately, such:
- Personnel handling waste must wear appropriate PPE.
- Dispose of materials following local hazardous waste regulations.
- Use clearly labeled, leak-proof containers.
- Segregate solid and liquid waste.
For monitoring and validation, with regular monitoring ensures that environmental standards are consistently met:
- Particulate monitoring using particle counters.
- Microbiological sampling (air, surface, personnel gloves).
- Validation and calibration of airflow, pressure, and HEPA filters.
- Documentation of all cleaning and maintenance activities.
As Conclusion, for maintaining a clean cytotoxic room for chemotherapy drug preparation requires a combination of controlled environment design, proper equipment,strict hygiene practices, and also ongoing staff training.
These measures ensure that chemotherapy medications are prepared safely, minimizing risk to both healthcare workers and patients. (IW 0311)