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MPJE - USP Chapter 795 – Pharmacy Compounding – Sterile Preparations

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.
Created by: LilTren