An Environmental Sampling Plan Confirms the Effectiveness of:
- Personnel and Material Work Flows
- Cleaning
- Deviation and Corrective Actions
- Engineering Controls
- Personnel Training
- Quality Assurance System
Typical Environmental Tests
- Chemo Wipe Testing
- Differential Pressure*
- Non-Viable Air (total particulates) T
- emperature/Relative Humidity*
- Viable Air (no settle plates)
- Viable Surface
*<797> Revision requires continuous monitoring devices
Keys to a Successful Sampling Plan
- Robust policies and procedures that define sample interval, sample locations, acceptance criteria, data review and approval and trending
- Dedicated and trained staff
- Quality System is seamlessly integrated into operations
- Microbial identification when over limits
- Training and on-going assessments
Common Challenges for In-House Testing
- Availability of equipment
- Deviation investigation and corrective action
- Documentation management
- Evaluation of the effectiveness of cleaning/ disinfection agents and cleaning processes
- Maintenance, calibration and repair
- Plate inventory and management
- Time
Common Causes for Excursions
- Facility design and engineering controls
- Flow of Materials and Personnel
- Lines of demarcation
- Ineffective gowning
- Materials not wiped down
- Incomplete training
- Lack of on-going assessments
