USP 795, 797, and 800 non-clean and cleanroom standards are essential for a facility handling sterile hazardous, and non-hazardous drugs to protect both healthcare employees and patients. Filtration Technology Inc. specializes in the design and construction of non-clean and cleanroom facilities, building our enclosures with the most up-to-date technologies to ensure safety and regulatory compliance.
USP 795 Standards
USP 795 standards apply to non-sterile and non-hazardous and drug compounding. The main requirements include:
- Layout and construction of the room must prevent entry of contaminants into the compounding area.
- The air supply must be directed to the uncontrolled environment, with airflow being regulated to not create turbulence or disrupt airflow.
- Neutral or positive pressure maintained in the compounding areas to prevent outside contaminants from entering.
USP 797 Cleanroom Standards
USP 797 is a set of guidelines for the handling, preparing, and compounding of sterile products to prevent microbial contamination and maintain safe practices. Some key requirements include:
- Air cleanliness standards must be met, with a minimum of 30 Air Changes per Hour to control particulate matter in the air.
- Minimum 0.02″ water column of positive pressure must be maintained to prevent cross-contamination.
- All surfaces and equipment must be regularly cleaned and sanitized.
- ISO Class 7 Cleanroom conditions.
USP 800 Non-Clean and Cleanroom Standards
USP 800 non-clean and cleanroom standards have been set to minimize the risk of exposing humans to hazardous drugs. The key requirements of these USP cleanrooms include:
- These rooms must maintain a minimum negative pressure of 0.02 inches of water column to prevent contaminants from escaping.
- A minimum of 12 Air Changes per Hour ensures adequate ventilation and containment for hazardous drug non-sterile environments .
- A minimum of 30 Air Changes per Hour and ISO Class 7 Cleanroom conditions for hazardous drug sterile environments.
- All air must be externally exhausted without recirculation to avoid contamination.
- Separate areas for sterile and non-sterile compounding are necessary to prevent cross-contamination.
Key Components and Equipment for USP 795, 797, 800 Non-Clean and Cleanrooms
Containment Primary Engineering Controls (C-PECs)
C-PECs, such as Class II Biological Safety Cabinets (BSCs), must be externally vented to prevent contamination. These devices are essential for maintaining the sterility and safety of the compounding environment.
Containment Secondary Engineering Controls (C-SECs)
C-SECs involve buffers and anterooms that must maintain ISO Class 7 or better conditions. Proper design and monitoring of these areas ensure compliance with USP 800 non-clean and cleanroom standards.
HVAC Systems
A robust HVAC system is crucial for maintaining negative pressure and proper air filtration. Filtration Technology provides HVAC solutions tailored to meet the specific needs of cleanrooms, ensuring compliance with USP 795 standards.
Monitoring Systems
Continuous monitoring for pressure, airflow, and filtration is essential to maintain compliance. Regular maintenance protocols ensure that the cleanroom environment remains within the required standards.
Specialized Areas and Equipment for USP 795, 797, 800 Non-Clean and Cleanrooms
Storage Requirements
Hazardous drugs must be stored in dedicated negative pressure rooms with at least 12 Air Changes per Hour. This prevents cross-contamination and ensures the safety of the drugs and the environment.
Unpacking and Receiving Areas
These areas must be neutral or negative pressure zones to prevent contamination during the unpacking of hazardous drugs. Proper design and setup are essential to meet USP 797 cleanroom standards.
Security and Access Controls
Enhanced security measures, including restricted access and proper labeling, are required to comply with USP 800 non-clean and cleanroom standards. Filtration Technology provides solutions to ensure these standards are met.
Filtration Technology’s Solutions for USP 795, 797, 800 Compliance
Custom Cleanroom Design and Build
Filtration Technology specializes in designing cleanrooms that meet USP 795 standards. Our expertise ensures that every room is tailored to the specific needs of the facility, providing modular and prefabricated options for efficient setup.
Comprehensive Product Range
Our wide range of products that guarantee compliance with USP 797 cleanroom standards include:
- Filters: High-efficiency, washable, disposable, pleated, HEPA, ULPA, and more.
- Specialty Equipment: Enclosures, HVAC systems, monitoring systems, laminar flow benches, powder contaimnet hoods, chemo hoods, sinks, and cleanroom furnishings.
Installation and Retrofitting
We offer tailored solutions for new installations and upgrades to existing facilities to comply with the USP standards. The team works closely with the healthcare facility to ensure that the installation causes minimal disruptions.
Ongoing Support and Maintenance
Our services include regular inspections, maintenance, and any necessary updates toward continued compliance with the USP standards. We provide the comprehensive support your facility needs to keep your cleanroom environment safe and compliant.
Consultation and Compliance Assistance
Filtration Technology provides professional consultation to evaluate your facility’s needs and guarantee compliance with all significant regulatory requirements. Our experienced professionals assist in navigating the intricacies of USP standards from start to finish.
Get Started with Your USP 795, 797, 800 Compliance Today
Contact Filtration Technology, Inc. today to schedule a consultation and ensure your facility meets USP 795, 797, and 800 non-clean and cleanroom standards. Our experts are ready to assist with all your cleanroom design, installation, and maintenance needs.