Understanding OPQ Hazardous Sterile Compounding Standards
The Ordre des pharmaciens du Québec (OPQ) is the professional regulatory body for pharmacists in Quebec. The OPQ has established comprehensive standards for the preparation of hazardous sterile drugs to protect pharmacy personnel from occupational exposure and ensure patient and environmental safety.
Scope and Application
OPQ standards apply to all Quebec pharmacies involved in the preparation of hazardous sterile drugs, including:
- Hospital Pharmacies — Preparing hazardous drugs for patient administration
- Specialty Pharmacies — Dedicated to oncology and specialized drug preparation
- Compounding Pharmacies — Preparing customized hazardous drug formulations
- Veterinary Pharmacies — Handling hazardous veterinary pharmaceuticals
Key Requirements
Facility and Containment Requirements:
Compounding areas must be physically separated from regular pharmacy operations and maintained under negative pressure relative to adjacent spaces. A negative pressure of at least 0.01 to 0.05 inches of water column is typically required to ensure proper containment.
Biological Safety Cabinet (BSC):
A Class II Type B2 biological safety cabinet must be used for all hazardous sterile compounding. The BSC provides:
- Worker protection through inward airflow
- Product protection through HEPA-filtered laminar airflow
- Environmental protection through HEPA-filtered exhaust air
ISO Air Classification:
The buffer room must maintain ISO Class 7 air quality standards:
- Maximum 352,000 particles (≥0.5 μm) per cubic meter
- Minimum 12 air changes per hour (ACPH)
- Appropriate temperature and humidity control
Environmental Monitoring:
Regular environmental monitoring must include:
- Viable air sampling (microbial contamination)
- Non-viable particle counting (air quality verification)
- Pressure differential monitoring (containment verification)
- Decontamination effectiveness verification
Personnel Protective Equipment:
Required PPE includes:
- Double gloves (nitrile recommended)
- Full-body protective gown
- Head and hair covering
- Shoe covers
- Eye protection
- NIOSH-approved respirator
Decontamination and Deactivation:
Specific procedures must be established for:
- Daily decontamination of BSC work surfaces
- Periodic decontamination of the entire compounding area
- Deactivation of hazardous drug residues
- Documentation of all decontamination activities
Hazardous Waste Management:
Procedures must be documented for:
- Segregation of hazardous waste from regular waste
- Storage in clearly marked, secure containers
- Proper disposal through authorized hazardous waste handlers
- Complete tracking and documentation
How ATEK Supports OPQ Compliance
ATEK’s environmental monitoring platform is designed to help Quebec pharmacies maintain the rigorous environmental standards required by OPQ regulations.
Negative Pressure Monitoring
ATEK’s differential pressure sensors provide:
- Real-time Monitoring — Continuous pressure differential measurement between the compounding area and adjacent spaces
- Immediate Alerts — Automatic notifications if pressure differentials fall outside required ranges
- Historical Trending — Data analysis to identify pressure maintenance patterns and potential issues
- Regulatory Documentation — Complete audit trails for OPQ inspections and audits
Air Quality Verification
Our environmental monitoring tracks:
- Particle Counts — Non-viable particle measurement to verify ISO Class 7 compliance
- Viable Sampling Integration — Coordination with microbial monitoring schedules
- Data Correlation — Linking environmental conditions with compounding activities
- Trend Analysis — Identifying any degradation in air quality over time
BSC and Equipment Monitoring
ATEK helps verify:
- BSC Airflow Parameters — Monitoring negative pressure and airflow characteristics within the cabinet
- Equipment Operational Status — Documenting that equipment is functioning within specifications
- Maintenance Tracking — Recording service and certification activities
- Performance Verification — Continuous verification that equipment maintains required performance standards
Comprehensive Compliance Documentation
ATEK provides:
- Automated Data Logging — All environmental parameters are automatically recorded with timestamps
- Regulatory Reports — Pre-formatted reports designed for OPQ compliance submissions
- Audit Trail Documentation — Complete immutable records of all monitoring activities
- Incident Investigation Support — Detailed environmental data for incident analysis and root cause investigation
Implementation Best Practices
Integration with Standard Operating Procedures:
Environmental monitoring data should be integrated into your pharmacy’s SOP for hazardous drug compounding, including:
- Monitoring schedules and alert response procedures
- Data review and approval processes
- Documentation retention policies
Personnel Training:
Ensure all pharmacy personnel understand:
- The importance of environmental monitoring for safety
- How to respond to monitoring alerts
- The role of environmental data in compliance
Regular System Maintenance:
ATEK sensors and equipment require:
- Regular calibration verification
- Periodic maintenance per manufacturer specifications
- Annual validation to ensure continued accuracy
Documentation Management:
Maintain organized records of:
- All environmental monitoring data
- Equipment maintenance and calibration records
- Personnel training and competency assessments
- Any environmental deviations and corrective actions taken