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MPJE
MPJE - USP Chapter 795 – Pharmacy Compounding – Sterile Preparations
Term | Definition |
---|---|
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. |
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. |
Critical site | Risk of microbial particulate contamination of the critical site increases with size of the openings and contact time with air |
Direct Compounding Area (DCA) | A critical area within the ISO Class 5 primary engineering control where critical sites are exposed to First Air |
First Air | The air exiting a HEPA filter in a unidirectional air stream, that is essentially particular free. |
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. |
ISO Class | The quality of air cleanliness proceeds along: ISO Class 5 > ISO Class 7 > ISO Class 8. |
Primary Engineering Control (PEC) | A device or room that provides a ISO Class 5 environment for the exposure of critical sites when compounding CSPs |
Primary Engineering Control (PEC) | laminar airflow workbenches, biological safety cabinets (BSCs), compounding aseptic isolators, and compounding aseptic contamination isolators. |
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 |
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. |
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). |
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). |
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). |
Personnel Training and Evaluation in Aseptic Manipulation Skills | didactic tests, competent skills in aseptic technique , documented in employment records |
Viable Particulate Monitoring | DCA and PEC compounding areas need to be periodically reviewed by qualified personnel to validate minimal presence of airborne microbial organisms |
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. |
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. |
Facilities | This includes specific placement for PEC in compounding areas, in addition to specific guidance for ventilation and airflow patterns |
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 |
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. |