Consolidated Sterilizer Systems (CSS)
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Performance Qualification (PQ) Services
Performance Qualification (PQ) documents the sterilizer’s ability to achieve the desired outcome (i.e. sterilization of specific loads when operated in accordance with predefined operating procedures).
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- The sterilizer is tested with actual production loads.
- Thermocouples are placed within the load items at positions presenting process challenge locations.
- In addition to temperature mapping, biological indicators (BI’s) may be used to demonstrate compliance with all user requirements.
- Prior to PQ all required methods and Standard Operating Procedures must be finalized and operator training completed.