Key Requirements Under USP <797>

• Sterile Compounding Standards: USP <797> requires that CSPs are prepared in designated sterile environments, with segregated spaces for non-hazardous compounding.
• Primary & Secondary Engineering Controls: These include equipment like ISO 5 PECs for sterile operations, which should be located in an ISO 7 buffer room.
• Environmental Monitoring: Regular monitoring of air, personnel, and surfaces ensures the compounding environment remains safe and uncontaminated.

USP <800> Additions for Hazardous Drug Handling

• Containment Primary Engineering Controls: Hazardous drug compounding must be performed in ISO 5 C-PECs, such as Biological Safety Cabinets or Compounding Aseptic Containment Isolators (CACIs), externally vented for safety.
• Negative Pressure Control: Hazardous drug compounding areas must maintain a negative pressure differential to prevent HD particles from escaping to cleaner areas.

Ventilation Standards

• Non-Hazardous Compounding: Positive pressure in cleanrooms ensures airflow from cleaner to less clean areas, minimizing contamination.
• Hazardous Compounding: Negative pressure ensures containment, with HEPA filters capturing 99.97% of particles, significantly reducing exposure risks for healthcare workers and the environment.

Key Problems and Pain Points in USP Compliance

• Adapting to Revised Standards: Healthcare providers often face logistical and financial challenges when updating facilities to meet USP <797> and <800> changes, especially without disrupting patient care.
• Compounding Safety and Continuity: Complying with revised USP standards is essential to ensuring the safe preparation and delivery of sterile medications, yet hospital renovations can be costly and time-consuming.

Designing with flexibility in mind, such as modular and mobile compounding pharmacy setups, enables rapid adjustments to evolving USP standards. Modular layouts make it easy to expand, reconfigure, or relocate spaces, helping you stay aligned with regulatory updates as they come.

To maintain a safe environment, integrate key engineering controls such as Class II Biological Safety Cabinets (BSCs) and Containment Aseptic Compounding Isolators (CACIs). Effective C-PEC (Primary Engineering Control) and C-SEC (Secondary Engineering Control) setups are essential for mitigating exposure to hazardous drugs, helping to meet USP <800> standards and protect both patients and staff.

Daily environmental monitoring—including tracking temperature, humidity, and particle counts—helps ensure that your facility operates within safe parameters. Regular checks allow for early detection of deviations, supporting a sterile environment crucial for compliant compounding.

As healthcare providers continue to align with the new USP <797> and <800> standards, the focus on safety and compliance remains crucial for patient and worker well-being. These protocols set a high bar, guiding compounding pharmacies toward greater safety, reliability, and efficiency.

For facilities still on the path to full compliance, Germfree provides a range of adaptable solutions—from modular cleanrooms to mobile units and containment systems—that simplify transitions and support optimal safety standards. By partnering with Germfree, facilities can ensure their infrastructure aligns seamlessly with USP requirements.

In an evolving regulatory landscape, embracing innovative technologies, refining workflows, and investing in advanced engineering controls will be key. Facilities committed to proactive change management and prioritizing safety will not only meet today’s standards but set the pace for a safer, more resilient future in healthcare.