Modular Cleanrooms For Compounding Pharmacies: Increase Your USP 797/800 Compliant Space

Increasing USP 797/800 compliant compounding pharmacies

Germfree modular compounding pharmacies are the 2nd fastest way to address surge capacity, increase compounding throughput and address hospital compounding needs. Proven over decades, by hundreds of hospitals, our mobile hospital pharmacy will continue to be the only option faster than a modular compounding pharmacy capable of increasing your USP 797/800 compliant space.

Germfree provides all aspects of your hospital pharmacy operations in our modules. Our facility provides an aseptic environment and our full 100% stainless steel pharmacy equipment line protects your personnel and materials. Germfree Modular facilities are freestanding with all HVAC, MEP, and site infrastructure connections available to tie in with your existing facility.

• Connects to existing operations
• Freestanding outside in any region
• Scalable in ~770 sq. ft. sections
• Maintained & Serviced Germfree
• Independent HVAC design
• Efficient workflow design

Single Module Compounding Pharmacies

The room classification flow of this facility is an entry room connected to an ISO 8 buffer room leading into the ISO 7 USP 797/800 non-hazardous compounding suite.

On the hazardous side, the classification flow is entry room to ISO 7 buffer room leading into the ISO 7 USP 797/800 hazardous compounding suite with an auxiliary ISO 8 hazardous material storage.

Compounding Pharmacies Specifications

Room Classification Types

• CNC Entry
• ISO 8 Material Storage
• ISO 7 Hazardous Buffer
• ISO 7 Anteroom
• ISO 7 Non-Hazardous Buffer
• ISO 8 Anteroom
• NC Mechanical Room

Mechanical

• Our largest module is 14′ x 56 feet and can decrease in size in 2 foot increments
• Fully integrated HVAC with separate mechanical space
• Our single HVAC system accommodates hazardous and non-hazardous compounding in the same facility through HVAC segregation
• When connecting multiple modules our patented, sealed, connections maintain USP<797>/USP<800> compliance

Electrical

• Module equipped to support 3 phase distribution
• Dedicated backup panels for critical facility operations
• ISO 7 spaces use sealed conduit NFPA 70 NEC 2020 Compliant

Plumbing

• Internal, domestic water distribution point ready to accept site water connections
• Eyewash in anterooms
• Complaint with current International Building Code (IBC)

Door Controls

• Wave to open door controls with configurable interlocks and timing
• Variety of access control systems can be integrated

Building Management System

• A central BMS controls all aspects of the facility via BACnet and can report via BACnet to a centralized facility

Environmental Monitoring System

• Optional: 21 CFR Part 11 EMS system that can serve as permanent record keeping on environment conditions
• Room temperature, relative humidity, room pressure “at rest” and “in operation”, and differential pressures are all captured

Architectural

• All finishes are durable against harsh cleaning agents such as sporicidal agents and VHP
• Every build decision prioritizes a sealed, smooth, cleanable and compliant interior envelope
• Seamless 40′ Arcoplast ® walls

Integrated Equipment

• Germfree Vertical and Horizontal Laminar Flow Workstations
• Germfree Biosafety Cabinets, Class 2 A2 and B2
• Germfree Active-HEPA Material Pass Through

Security, Access, Fire & Data

• Code access with optional key card access into facility
• Sprinkler, Material, & Fire panels built to local code
• Designated data communications panel for integration with existing facility

Site Requirements

• Concrete pad or pillars
• Fresh and Grey Water connections
• Electrical utility connections
• Staff access and site security

The Germfree difference

Factory Acceptance, Onsite Testing & Quality Control

Modular compounding pharmacies are factory acceptance tested before shipment and tested onsite to support USP 797/800 compliance submittals and documentation.

Project Management

We manage all complexities associated with your project: URS development, operational flow design, basis of design, site infrastructure audits, engineering, installation, PEC equipment manufacturing, and more.

Support & Maintenance

Germfree’s service team supports facilities 24/7, providing preventative monitoring, diagnostics and maintenance worldwide.

Flexible, Adaptable, Cost saving construction methods

Our modules can be relocated by our service team, they can scale in ~760 sq ft increments, and our robust single HVAC system allows hazardous and non hazardous compounding in a single module.