
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
Sterile Hazardous Drug Compounding & Drug Development …
We specialize in Containment Primary Engineering Controls (C-PEC) for sterile compounding of hazardous drugs, meeting strict USP <800> standards. Our Class II, Type A2, and Type B2 Biosafety Cabinets (BSC) are designed to improve pharmacy workflow and simplify cleaning, ensuring safety and efficacy for healthcare professionals.
Controlling Occupational Exposure to Hazardous Drugs
Priming IV sets or expelling air from syringes should be carried out in a C-PEC. If priming is done at the administration location, spiking should be performed using an adapter that minimizes leakage, and IV sets should be primed with non-drug containing solution using a …
Cleanroom Glossary and Definitions: USP 797, USP 795, USP 800
2018年4月24日 · C-PEC (Primary Engineering Control) Containment Primary Engineering Control; Examples of C-PECs include Class I, II, or III BSCs, CACIs, and CVE. It’s the device in which the compounding will occur.
USP 800 Cleanroom Design – Negative Pressure Changes and …
2019年7月9日 · A Containment Primary Engineering Control (C-PEC) sits within a sealed, walled-off room. The room surrounding the C-PEC functions as Containment Secondary Engineering Controls (C-SEC). A Containment Secondary Engineering Control (C-SEC): Externally vented, 12 air changes per hour, negative pressure between 0.01 – 0.03 inches of water channel
USP 800 non sterile compounding - AirClean Systems
According to Section 5.3.1 of <800>, "Nonsterile HD compounding must be performed in a CPEC [an enclosure] that provides personnel and environmental protection such as a Class I BSC or Containment Ventilated Enclosure (CVE)."
Containment PECs (C-PECs) are externally ventilated devices that provide a particle-free work environment that also minimizes HD exposure through negative pressure or controlling the direction and speed of airflow into the device.
Interpreting USP 800 Table 2 Primary Engineering Controls
The containment secondary engineering control (C-SEC) is considered the hazardous drug room, with fixed walls, segregating it from other nonhazardous compounding and pharmacy activities. If the C-PECs are connected to an external exhaust blower, then the C-PECs are contributing to the C-SECs negative pressure.
Upgrading a USP 797 Cleanroom to USP 800? - Technical …
2018年4月27日 · USP 800 requires all hazardous drug compounding occur within a primary engineering control (C-PEC). The C-PEC is a location within a containment secondary engineering control (S-PEC). In practice, an ISO Class 5 flow hood within an ISO Class 7 buffer area is generally sufficient.
chapter, the C-PEC is described for sterile HD compounding as “…an ISO Class 5 or better air quality, such as a Class II or III BSC or CACI. Class II BSC types A2, B1, or B2 are acceptable. For most known HDs, type A2 cabinets offer a simple and reliable integration with the ventilation and pres-surization requirements of the C-SEC. Class