USP 797 Pharmaceutical Compounding - Sterile Preparations establishes requirements for sterile compounding to help ensure patient safety. A critical component of compliance is proper environmental monitoring, including temperature control.
Overview of USP 797
The United States Pharmacopeia (USP) Chapter 797 provides standards for compounding sterile preparations (CSPs). The chapter underwent significant revisions, with the current version emphasizing risk-based approaches to sterile compounding.
Key areas covered include:
- Personnel training and hygiene
- Facilities and engineering controls
- Environmental monitoring
- Cleaning and disinfection
- Beyond-use dating
- Quality assurance
Temperature Requirements by Category
Category 1 CSPs
Category 1 preparations are compounded under less stringent conditions:
- Ambient temperature storage: 20-25°C (68-77°F)
- Refrigerated storage: 2-8°C (36-46°F)
- Frozen storage: -25 to -10°C (-13 to 14°F)
Category 2 CSPs
Category 2 preparations require more rigorous controls:
- Same storage temperature ranges as Category 1
- More frequent environmental monitoring
- Stricter facility requirements
Cleanroom Temperature Requirements
USP 797 specifies environmental parameters for classified compounding areas:
ISO Class 5 Primary Engineering Controls (PECs)
- Temperature: 20°C ± 2°C (68°F ± 4°F)
- Humidity: 30-60% RH recommended
- Positive pressure differential maintained
ISO Class 7 Buffer Rooms
- Temperature: 20°C ± 2°C (68°F ± 4°F)
- Humidity: Below 60% RH
- Minimum 30 air changes per hour
ISO Class 8 Ante Areas
- Temperature: 20°C ± 2°C (68°F ± 4°F)
- Humidity: Below 60% RH
- Minimum 20 air changes per hour
Monitoring Requirements
Continuous Monitoring
USP 797 requires continuous monitoring of critical parameters:
- Temperature - Continuous recording in all storage areas
- Differential Pressure - Between classified spaces
- Humidity - In cleanroom environments
Documentation Requirements
All environmental monitoring data must be documented and include:
- Date and time of readings
- Location of measurement
- Actual values recorded
- Person responsible for monitoring
- Actions taken for out-of-specification results
Storage Area Monitoring
Medication Refrigerators
For refrigerated CSPs:
- Continuous temperature monitoring required
- Daily temperature log documentation
- Alert systems for excursions
- Regular calibration of monitoring devices
Hazardous Drug Storage
Additional requirements for hazardous drug areas:
- Negative pressure relative to adjacent spaces
- Continuous pressure monitoring
- External exhaust (no recirculation)
Excursion Management
When temperature excursions occur:
- Document the excursion immediately
- Investigate the cause
- Assess impact on affected CSPs
- Quarantine potentially affected preparations
- Implement corrective actions
- Prevent recurrence through root cause analysis
Best Practices for Compliance
Automated Monitoring Systems
Manual temperature checks are no longer sufficient for USP 797 compliance. Automated systems provide:
- Continuous 24/7 monitoring
- Immediate alert notifications
- Complete audit trails
- Simplified compliance reporting
Sensor Placement
Proper sensor placement is critical:
- Map temperature distribution in storage units
- Place sensors in warmest/coldest locations
- Use buffered probe sensors for stability
- Document sensor locations
Calibration
Monitoring equipment must be calibrated:
- Annual calibration recommended
- NIST-traceable standards
- Documentation of calibration certificates
- Calibration before initial use
ATEK Solutions for USP 797
ATEK’s environmental monitoring platform addresses USP 797 requirements:
- Continuous monitoring of temperature, humidity, and differential pressure
- Automated alerts via SMS, email, and phone
- Complete audit trails for regulatory compliance
- Custom reporting for compliance documentation
- 24/7 monitoring with escalation protocols
Preparing for Inspections
State Board of Pharmacy inspectors will verify:
- Continuous temperature documentation
- Evidence of monitoring system calibration
- Excursion documentation and follow-up
- Written procedures for environmental monitoring
- Staff training records
Conclusion
USP 797 temperature monitoring requirements are essential for ensuring the safety of sterile preparations. Implementing an automated environmental monitoring system helps pharmacies maintain compliance while protecting patient safety.
For information about how ATEK can support your USP 797 compliance, contact us for a consultation.