25 Chapter 25: Sterility and Cleanliness Requirements
Maintaining cleanliness and ensuring appropriate environmental control is essential in non-sterile compounding to protect patient safety and ensure product quality. While sterility is not a requirement for non-sterile preparations, cleanliness, containment, and contamination control are critical, especially for hazardous or sensitive preparations. The NAPRA Model Standards for Non-Sterile Compounding provide detailed requirements to reduce the risk of contamination, ensure product quality, and protect personnel and patients.
Cleanliness & Environmental Control in Non-Sterile Compounding (Based on NAPRA Guidelines)
- Designated Compounding Areas
- Separate and dedicated spaces must be used for non-sterile compounding to prevent cross-contamination.
- Hazardous and non-hazardous compounding must be physically separated.
- Compounding must not occur in areas where:
- Eating or drinking occurs
- Waste is processed
- Foot traffic is high
- Cleaning and Disinfection Protocols
NAPRA requires routine and documented cleaning procedures for the compounding environment.
Cleaning and Disinfection Protocols:
| Surface/Equipment | Frequency | Cleaning Requirements |
| Work surfaces | Before & after each compounding session | Clean with appropriate detergent; rinse; disinfect |
| Equipment (mortars, balances, etc.) | Before first use, between preparations, and after use | Clean and disinfect with product-safe agents |
| Floors | Daily or more often if needed | Mop with low-lint materials; clean spills immediately |
| Storage shelves | Monthly | Dust and disinfect regularly |
| C-PEC interiors (for HDs) | At least daily and after spills | Follow a 4-step process: deactivate, decontaminate, clean, disinfect |
**NAPRA requires written procedures for all cleaning protocols and a log to record each cleaning activity.
- Personal Hygiene and PPE
- Hand hygiene is mandatory before entering the compounding area and before donning PPE.
- No jewelry, nail polish, or cosmetics allowed.
- Clean lab coats or gowns must be worn; change as needed (e.g., between different types of products).
- For hazardous non-sterile compounding, PPE must meet Section 9.2.3 of NAPRA, including:
- Two pairs of chemotherapy-rated gloves (ASTM D6978)
- Gowns with chemical resistance (polyethylene-coated)
- Head/hair/shoe covers
- Eye/face protection
- Respiratory protection (e.g., N95 or full-face respirator) when needed
- Environmental Controls
- Temperature and humidity must be monitored and maintained within acceptable ranges (as defined by monographs or product needs).
- Ventilation must ensure adequate air exchanges, especially in areas where hazardous ingredients are handled.
Hazardous non-sterile compounding must occur in a C-PEC located within a C-SEC (Containment Secondary Engineering Control) that meets ventilation standards.
- Documentation and Quality Assurance
- NAPRA mandates a comprehensive QA program with:
- Standard Operating Procedures (SOPs)
- Cleaning logs
- Equipment maintenance records
- Environmental monitoring logs
- Incident and deviation reports
