BioPharma Modules – Flexible cGMP Facilities
Self-contained Cleanroom Production & Containment Space
Germfree designs and manufactures complete modular facilities to provide fast and flexible cGMP-compliant production space. Our BioPharma Modules incorporate cleanroom process areas as well as any needed containment for potent APIs. They are built to handle your current requirements and can be reconfigured for future process change-outs.
BioPharma Modules are built to the optimal size for your applications. They are self-contained and suitable for installation into an existing building or as a freestanding facility. These scalable units meet or exceed the functional and structural quality of traditional construction while significantly reducing the project timeline.
Germfree – The Engineering Control Experts for Cleanrooms and Labs
The foundation of any cGMP-compliant space is a durable, well-designed structure that properly integrates the engineering controls. It is critical that HVAC, filtration and containment systems are precisely configured. Any high containment areas must be properly calibrated and part of the overall BMS. Germfree’s expertise assures that all engineering systems fulfill the requirements of any biopharmaceutical process.
Additionally, Germfree is the only OEM that builds the facility as well as manufacturers all core air filtration and containment equipment. This assures that all components are integrated into the initial project design. Our line of 316L stainless steel equipment includes: RABS, pharmaceutical isolators, biological safety cabinets, unidirectional (laminar flow) clean air benches, powder containment enclosures and fume hoods.
BioPharma Modules – The Answer to New Process Challenges
Current and emerging biotherapeutics require innovative production strategies. Legacy buildings and production platforms often are not easily adapted to these applications. There is also a need for flexible space that can be repurposed for new biologics and APIs. Traditional construction is too rigid or slow for solving many of these challenges. A modular approach, when properly implemented, is ideal for meeting these demands.
Germfree’s BioPharma Modules are manufactured and pre-qualified in our controlled factory environment. Our leading-edge fabrication technology, engineering teams and subject-matter experts are located at our 140,000 square foot (13,000 square meter) US manufacturing plant. Having a single source solution simplifies the complexity of factors inherent to brick and mortar buildings. We mitigate the risk of on-site construction variables and delays. Our approach results in an accelerated project timeline.
BioPharma Modules – Flexible for Early Stages of Drug Development
Germfree’s BioPharma Modules provide an optimal platform when dedicated space is needed for preclinical drug development or small-batch production for clinical trials. Our facilities are reconfigurable and can be repurposed to accommodate the next project in the pipeline.
Configured for Your Current Process – Flexible for Future Applications
BioPharma Modules meet the rigorous aseptic processing and containment demands for a wide range of biopharmaceutical applications, which include:
- Germfree’s self-contained BioPharma Modules do not require any complex on-site infrastructure
- Fast-track design process
- Optimal integration of HVAC for a low ratio of mechanical space
- 316L stainless steel integrated biosafety and laboratory equipment
- Modules/zones for designated ISO cleanroom classifications
- Biocontainment up to BSL-3
- All cGMP-compliant materials and interior finishes for durability and ease of decontamination
- Units are pressure decay tested to insure integrity
- Arcoplast walls and ceilings; Cleanroom-certified seamless vinyl flooring; radius coved corners
- Pharmaceutical grade fixtures and casework including movable carts and tables
- Ability to disconnect MEP for relocation
- Modules can be reconfigured and repurposed
- Units meet or exceed the functional and structural quality of a site-built facility
- Scalable as drug development or production is ramped up
- Effective as a separate dedicated lab such as: quality control (QA/QC), chemistry and molecular-PCR laboratories
- Collaborative design process; 3D Modeling
- Modules for R&D batches; small-batch manufacturing including Phase I & II clinical trials
- Available as a single cleanroom or designed for separate production and containment zones
- Modules may be connected together to create a large, open floor plan
- Integrated into upstream or downstream processes
- Moderate footprint is compatible with some continuous manufacturing operations
- IQ/OQ; complete validation and documentation package
- Factory Acceptance Testing; Factory pre-qualification and readiness for on-site validation, certification or commissioning
- Easily installed in warehouse/shell buildings, existing space or free-standing
- Factory-based global installation team and logistics experts
- Germfree is a single source OEM for both the module and core equipment
Germfree Deploys Advanced cGMP-Compliant Capabilities to any Region
There is an increasing demand for biomanufacturing facilities located in the markets being served. Close-proximity of production or clinical trials has many advantages. BioPharma Modules are a practical approach to meeting the challenges of producing sensitive therapeutics and maintaining the cold chain. We have experience with modular installations in remote locations worldwide. Our units are engineered for effective operations, compatible with local resources.
Manufacturing Air Filtration and Containment Systems for More than Five Decades
Germfree’s BioPharma Modules offer a highly flexible approach to adding cGMP-compliant infrastructure. New types of drugs and biomanufacturing techniques require more agile production platforms. We provide a range of solutions for both preclinical-stage startups and pharmaceutical manufacturers.
Contact our engineering experts to discuss your specific biopharmaceutical application.