USP <800> COMPLIANCE SERVICES
FACILITY & ENGINEERING CONTROLS
PRIORITIZING QUALITY, SAFETY & COMPLIANCE
At Eagle, we offer services that aid in meeting the USP <800> requirements for facility and equipment compliance. Our services include certifying Containment Primary Engineering Controls (C-PECs) and Containment Secondary Engineering controls (C-SECs) and conducting extensive reviews of your facility design and workflow. Our environmental quality and control (EQC) program is equipped with the necessary tools to detect hazardous drug residue on surfaces, and monitor those trends results continuously. We prioritize maintaining the highest levels of quality assurance and control to ensure optimal safety and compliance.
CLEANROOM CERTIFICATION & RECERTIFICATION
Eagle engineers know that the importance of doing routine testing to certify that the cleanroom meet specified requirements is vital in maintaining confidence in quality assurance programs. With Eagle’s engineers, you will feel confident that your cleanroom complies with applicable requirements.
- Full Cleanroom Certification to <797> and CETA Standards to include:
- HEPA Filter Integrity Testing (Leak Test)
- Differential Pressure Measurement †
- Air Change Per Hour Measurement and Calculation †
- Non-Viable Air Sampling (Particle Counts)
- Viable Air and Surface Sampling (Environmental Monitoring)
- Static Air Visualization (Smoke) Study
- Dynamic Air Visualization (Smoke) Study with Video and Report
- Laminar Airflow Workspaces (LAFW)
- Biological Safety Cabinets (BSC) †
- Powder Containment Hoods †
- Fume Hoods
† Tests that are specific for USP <800> compliance.
GAIN EXPERT KNOWLEDGE: FREE DOCUMENT
USP <800> Facility Design Considerations
USP <800> became applicable after updates to Chapters <795> and <797> on November 1, 2023. Additional considerations regarding construction must be addressed when designing a facility for Hazardous Drug compounding in non-sterile applications. This paper provides essential insights on proper facility construction.
FACILITY DESIGN REVIEW
Our engineering team will guide you through the building design and construction process, whether it be at startup or transition, to ensure that your facility is in compliance with the standards that govern your operations, including:
- Current Good Manufacturing Practice (CGMP)
- ISO 14644 Cleanrooms and Associated Controlled Environments
- USP <795> Pharmaceutical Compounding – Nonsterile Preparations
- USP <797> Pharmaceutical Compounding – Sterile Preparations
- USP <800> Hazardous Drugs – Handling in the Healthcare Settings
We can assist you in determining the optimal layout of your space to maximize efficiency and workflow all while keeping growth in mind.
ENVIRONMENTAL QUALITY & CONTROLS
WIPE SAMPLING & TRENDING OF RESULTS
Environmental monitoring (EM), which is a key element in ensuring that processing areas are maintained in an adequate state of control, can help verify the efficacy of your cleaning program. Wipe sampling is an important component of a full, comprehensive program in that it allows for a clearer understanding of contamination risks and serves as quality control for the other components of your HD safety program.
SURFACE SHIELD WIPE SAMPLING AND CLEANING VERIFICATION KIT
In an effort to create an easy, fast, and convenient method for verifying the efficacy of a cleaning program, including deactivation and decontamination, Eagle created the SurfaceShield Wipe Sampling and Cleaning Verification Kit. This multipurpose and affordable kit can be utilized to achieve and maintain USP <800> compliance and meet Title 21 Part 211 CFR requirements. Clients that submit their samples to Eagle for testing receive real-time updates on their sample’s progress Eagle’s free client portal and sample management EagleTrax app. EagleTrax Features:
- Real-time updates
- View sample results
- New Feature — Shield Analysis provides you access to your process control charts for easy trending
- Search through sample submissions
- Print reports
- And more
OUR OPERATIONS DEPARTMENT
Calibration, certification, qualification, and facility design review services are offered by Eagle’s Operations Department. The operations team consents of dedicated engineering and logistics professionals who are committed to providing expert and excellent care to our customers.
Eagle engineer performing differential pressure testing between ISO areas.
