USP <800> Explained
Before we begin, let us define terms applicable to USP <800> standards:
c-pec
Containment Primary Engineering Control:
A ventilated device designed to minimize worker and environmental hazardous drug exposure when directly handing hazardous drugs.
c-sec
Containment Secondary Engineering Control:
The designated room where the C-PEC is situated. It ensures the environment around the C-PEC remains controlled and secure.
hd
Hazardous Drug
Pertains to the toxic powder or active pharmaceutical ingredient that is handled within specific containment measures, ensuring safety for both workers and the environment.
hepa
High-Efficiency
Particulate Air
HEPA Filters are designed to capture and remove airborne particles, with at least 99.995% effectiveness.
acph
Air Changes Per Hour
Complete air replacements that occur within a Containment Secondary Engineering Control (C-SEC).
cve
Contained Vented
Enclosure
A specialized, vented containment enclosure ensuring both personnel and environmental protection.
class I
bsc
Biological Safety
Cabinet
A Class I BSC is a containment enclosure that safeguards both personnel and the environment.
CAI
Compounding
Aseptic Isolator
Aseptic Isolator
Provides aseptic conditions while preparing sterile medications, ensuring personnel safey.
CACI
Compounding Aseptic Containment Isolator
Provides sealed aseptic conditions for sterile compounding, ensuring personnel AND product safety.
Requirements for Non-Sterile HazarDous Compounding
Ensuring Safe & Effective Practices
At Flow Sciences, we recognize the significance of adhering to the requirements in HD compounding. Our expertise and comprehensive range of solutions empower you to achieve the utmost safety, compliance, and efficiency. Count on us to be your partner in upholding the highest standards in hazardous drug handling.
C-PEC ventilation requirements depend on the application. It can be externally vented (preferred) or redundant HEPA-filtered in series. Examples: CVE, Class I BSC, CAI or CACI
C-SEC MUST be externally vented AND have at least 12 ACPH. Externally vented, ≥ 12 ACPH, Negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas. Requirements vary based on application.
Variety of C-PEC Options: Flow Sciences offers an array of C-PEC solutions, including our time-tested CVE, Class I Bio-Safety Cabinets, and Compounding Aseptic Containment Isolators. Among these, our CVE paired with Single or Dual HEPA filtration units (dependent on application) stands out as an efficient solution to USP <800> compliance.
Connect with your experts in containment
Engineered Solutions
Recommended for USP <800> Applications
SINGLE HEPA, TOP MOUNT
NON-HAZARDOUS, NON-STERILE
Flow Sciences Contained Vented Enclosure with Single 4” HEPA filter and fan.
- Safe powder handling of hazardous drugs for personnel protection and reproducibility in sensitive application
- THIMBLE CONNECTION and VENT KIT required to connect CVE to the house exhaust system
- Stable airflow and NO VIBRATION on the work surface
DUAL HEPA, TOP MOUNT
HAZARDOUS, NON-STERILE
Flow Sciences Contained Vented Enclosure with Bag-In / Bag-Out Dual 4” HEPA filters and fan.
• RECIRCULATE into your lab to save money by requiring less make-up air and not venting out conditioned air
• FLEXIBILITY with placement in lab. Recirculate and move enclosure without moving house exhaust drops.
• Stable airflow and NO VIBRATION on the work surface
