Containment primary engineering control (C-PEC)—the device in which compounds are mixed, including a containment ventilated enclosure (CVE) commonly called powder hoods, a biological safety cabinet (BSC), and a compounding aseptic containment isolator (CACI). 2.

Apr 24, 2018 · The C-SEC is the room in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room (e.g., restricted access, barriers, special construction technique, ventilation, and room pressurization are components of the secondary control strategy).

The SCA shall include the PEC and extend to a line of demarcation between the PEC and other surrounding areas with a minimum clearance of 3.281 feet (1 meter) between the PEC and the line of demarcation. Nonhazardous Segregated Compounding Areas shall provide airflow from clean to less clean areas.

• Placement of primary engineering controls (PECs)—<797> allows placement of a compounding aseptic containment isolator (CACI) outside of a negative room. <800> requires all containment PECs (biological safety cabinets [BSCs] or CACIs) to be in a negative pressure room.

The segregated compound area (SCA) must contain a primary engineering control (PEC) and can only be used to prepare Category 1 compounded sterile preparations (CSPs). Garbing standard operating procedures must be in place and are determined by …

Manufactured sterile products that are either prepared strictly according to the instructions appearing in manufacturers' approved labeling (product package inserts) or prepared differently than published in such labeling.

PEC & SEC CERTIFICATION: PECs are certified initially and every 6 months to meet ISO Class 5 or better conditions, during dynamic operating conditions. SECs are certified initially and every 6 months to meet ISO Class 7 or 8 or better conditions, during dynamic operating conditions (including presterilization activities if applicable).

“Containment Primary Engineering Controls (C-PEC) must be located in a Containment – Secondary Engineering Control (C-SEC), which may either be an ISO Class 7 buffer room with an ISO Class 7 ante-room (preferred) or an unclassified containment segregated compounding area …

Segregated compounding area (SCA): A designated space, area, or room that is not required to be classified and is defined with a visible perimeter. The SCA must contain a PEC and is suitable for preparation of Category 1 CSPs only. ISO.

The Primary Engineering Control (PEC) shall be a negative pressure biological safety cabinet or isolator (CACI) as required. The workstation shall have an exhaust to the outside with a visible pressure gauge for detection of filter leaks or defects.