CETA – All COMBINED LATEST UPDATE

CETA – All COMBINED LATEST UPDATE Critical Area - ANSWER An ISO Class 5 environment Critical Site - ANSWER A location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical site increases with the size of the openings and exposure time. Direct Compounding Area - ANSWER A critical area within the ISO Class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air. Dynamic Operating Conditions - ANSWER The actual conditions in which the engineering control is used. All actual operating personnel are present and performing actual or simulated operations. Effective Area - ANSWER The actual facearea of the filter medium through which air is passing. This excludes the filter frame and center bar if present. For general purposes, the frame is assumed to be 2". First Air - ANSWER The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free Line of Demarcation - ANSWER A visible line on the floor that separates the room into areas for different purposes. For example, in the ante area the line separates the cleaner and less clean sides of the room. When the line of demarcation separates two different ISO classification areas, it must be accompanied by a minimum air velocity of 40 fpm from the cleaner area to the less clean area. Gowning Line - ANSWER A line of demarcation on the floor used to identify where the booties are donned in the gowning process. When this line does not identify a demarcation between ISO Classes it does not require airflow displacement of 40 FPM. Primary Engineering Control - ANSWER A device or room that provides a unidirectional airflow ISO Class 5 environment for the exposure of critical sites when compounding CSPs. Such devices include, but may not be limited to LAFWs, BSCs, CAIs, CACIs, and built in VLFs. Segregated Compounding Area - ANSWER A designated space, either a demarcated area or room, that is restricted to preparing low-risk level, nonhazardous CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding. Secondary Engineering Control - ANSWER The room or suite of rooms used to support sterile compounding operations. Primary engineering controls are placed inside secondary engineering controls. Secondary engineering controls include: ante areas, buffer areas, and segregated compounding areas. State of Control - ANSWER the practice of controlling variables to achieve the expected results. For the purposes of sterile compounding facility certification, a ____ is achieved when critical parameters used to achieve an appropriate environment for sterile compounding are managed and under control. Adequate HEPA filtered air is supplied to the room or PEC and the cleaner space is protected from less clean spaces by overpressure or displacement airflow. Unidirectional Airflow - ANSWER Controlled airflow from the entrance plane of the work zone that makes a single pass along generally parallel streamlines to the exit plane of the work zone with minimal turbulence, without back-flow, refluxing, and/or re-entrainment and at a velocity sufficient to sweep particles away from critical areas. Air is generally delivered to the work area through a HEPA or ULPA filter system or a diffuser that encompasses the entire entrance plane of the work zone. FDA recommends ___ ACPH minimum for ISO 8 area although this may not be adequate to maintain cleanliness in light of the activities that occur in ISO 8 ante areas. - ANSWER 20 HD buffer rooms should have a negative pressure of ___ " w.c. - ANSWER -0.01 All pressure readings should be documented to ____ of an "w.c. - ANSWER one thousands USP 797 requires all environmental controls to be certified at least every _ months. - ANSWER 6 ISO 7 Buffer Criteria - Minimum of ___ ACPH with at least ___ ACPH coming from the air supply through the room HEPA filters. - ANSWER 30 15 ISO 8 ante/buffer Criteria - not prescribed in USP 797, FDA recommends minimum of ___ ACPH. - ANSWER 20