MPJE - USP Chapter 795 – Pharmacy Compounding – Sterile Preparations
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| Aseptic processing | A mode of processing pharmaceutical products … that involves the separate sterilization of the product and of the package, and the transfer of the product into the container and its closure under at least ISO Class 5 conditions.
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| Critical site | A location that includes any component or fluid pathway surfaces or openings exposed and at risk of direct contact with air, moisture, or touch contamination.
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| Critical site | Risk of microbial particulate contamination of the critical site increases with size of the openings and contact time with air
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| Direct Compounding Area (DCA) | A critical area within the ISO Class 5 primary engineering control where critical sites are exposed to First Air
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| First Air | The air exiting a HEPA filter in a unidirectional air stream, that is essentially particular free.
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| ISO Class | International Organization for Standardization classification system for particulate matter in room air. There are three levels that are often referred to in USP 797.
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| ISO Class | The quality of air cleanliness proceeds along: ISO Class 5 > ISO Class 7 > ISO Class 8.
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| Primary Engineering Control (PEC) | A device or room that provides a ISO Class 5 environment for the exposure of critical sites when compounding CSPs
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| Primary Engineering Control (PEC) | laminar airflow workbenches, biological safety cabinets (BSCs), compounding aseptic isolators, and compounding aseptic contamination isolators.
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| Segregated Compounding Area | A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with a 12-hour or less BUD
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| Segregated Compounding Area | Such area shall contain a device that provides … ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding.
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| Low-risk level CSPs | 48 hours at controlled room temperature (20 to 25°C), 14 days under cold temperature (refrigeration; 2 to 8°C), or 45 days under solid frozen state (frozen; -25º to -10ºC).
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| Medium-risk level CSPs | 30 hours at controlled room temperature (20 to 25°C), 9 days under cold temperature (refrigeration; 2 to 8°C), and 45 days under solid frozen state (frozen; -25 to -10°C).
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| High-risk level CSPs | 24 hours at controlled room temperature (20 to 25°C), 3 days under cold temperature (refrigeration; 2 to 8°C), and 45 days under solid frozen state (frozen; -25 to -10°C).
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| Personnel Training and Evaluation in Aseptic Manipulation Skills | didactic tests, competent skills in aseptic technique , documented in employment records
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| Viable Particulate Monitoring | DCA and PEC compounding areas need to be periodically reviewed by qualified personnel to validate minimal presence of airborne microbial organisms
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| Non-Viable Particulate Monitoring | Segregated Compounding Areas, Direct Compounding Areas (DCA) and Primary Engineering Controls (PEC) need to be periodically reviewed by a qualified technician to validate the particulate quality of air in the environment.
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| Pressure differential and temperature monitoring | DCA and PEC areas must be monitored for air pressure and ambient temperature to ensure appropriate environment for CSP activities.
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| Facilities | This includes specific placement for PEC in compounding areas, in addition to specific guidance for ventilation and airflow patterns
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| Cleaning | Segregated compounding areas, DEC, and PEC must be cleaned and maintained in accordance with established guidelines. Cleaning requirements are based on facility design, activity being conducted, and have specific schedules
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| Personnel garbing and validation of aseptic technique | Personnel must utilize established hygiene and garbing standards. In addition, aseptic technique must be periodically evaluated using media fill tests and gloved fingertip samples in growth media.
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