ABOUT GERMFREE
Germfree manufactures a comprehensive line of barrier systems for aseptic control and containment as well as a complete mobile and modular cGMP facilities. We offer advanced solutions to maintain cGMP processes and production for a wide range of biopharmaceutical applications. We are a single source OEM provider of complete cleanroom and lab facilities, and the corresponding integrated equipment designed an purpose-built by our leading-edge fabrication technology, engineering teams and subject-matter experts.
FEATURED PRODUCTS
Discover Germfree’s custom modular radiopharmaceutical manufacturing or compounding cleanroom facility, expertly designed to accommodate a wide range of manufacturing and compounding requirements. This customizable solution caters to the long term capacity needs of radiopharmacies, individual hospitals or entire systems, providing the flexibility and efficiency necessary for today’s demanding healthcare environments.
bioGO® Mobile cleanrooms for radiopharmaceutical preparation and compounding
Discover Germfree’s custom mobile radiopharmaceutical compounding trailer or single module. These all-in-one facilities seamlessly serve individual hospitals or specialty compounding pharmacies
Standalone, turnkey, process ready cGMP modular cleanrooms
Germfree cGMP modular cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications. Serving processes from cell therapy to sterile fill-finish manufacturing cGMP modular facilities offer unmatched finishes, layout flexibility, controls, timeline assurance, and cost benefits for the biopharmaceutical industry. This is why Germfree has been chosen by 12 of the top 20 biopharmaceutical companies as their modular cleanroom providers.
Modular cleanrooms highlights: Biopharma, International building codes, IBC, NFPA, ISO. BSL-2 BMBL, FDA, EMA, cGMP compliant
Applications: Aseptic Filling, Cell Therapy, Gene Therapy, Viral Vector, Plasmids
The Future of Precision Medicine: Radiopharmaceutical Preparation for Targeted Diagnostics and Treatment
Safer and More Effective Radiopharmaceutical Production With Germfree's Advanced Cleanrooms and Equipment Solutions
Radiopharmaceuticals are drugs that contain radioactive isotopes and are used as diagnostic and therapeutic agents. Due to the hazardous nature of radioisotopes, lead shielded aseptic processing equipment is required for their production and handling. These cleanrooms have specific requirements such as HEPA exhaust and biosecurity features to prevent contamination and protect workers.
Germfree’s expertise in designing facilities and equipment for complex critical environments ensures compliant radiopharmaceutical preparation and production at varying scales. Radiopharmaceuticals play a crucial role in advanced therapies, including nuclear medicine and cancer treatment, and are a rapidly growing sector of the biopharmaceutical industry.
The RADIOSAFE Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. An optional thimble connection allows for external ducting of the exhaust air.
The Class II Type A RADIOSAFE Series of Biosafety Cabinets meets all requirements for USP 825 compliance and is constructed from 100% Stainless Steel.
Ensuring Safe Handling of High-Risk Biological Agents
Gloveboxes serve the needs of a diverse range of industries including biotechnology, biomedical, nuclear, defense, pharmaceutical, semiconductor and chemical applications. When these enclosures are used for microbiological research or to handle pathogens, they are referred to as Class III Biosafety Cabinets.
The Class 2, Type B2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area is continuously bathed with laminar flow ISO 5/Class 100 HEPA-filtered air while creating a negative pressure airflow into the cabinet to provide user protection.
The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.
Protecting Product and Process
Straddle Laminar Airflow units are used to provide product and process protection for large scale applications that would not be possible inside a standard laminar flow hood. Additionally, Straddle LAF units can be used to house robotic machines, such as those used for aseptic vial filling, closing, and capping. In many applications, use of a Straddle LAF can eliminate the need for an ISO 5 or better cleanroom.
Ensuring Aseptic Conditions and Containment in Pharmaceutical Industry Processes.
VIDEOS AND WEBINARS
CONTACT INFORMATION
Germfree
4 Sunshine Blvd
Ormond Beach, FL 32174
UNITED STATES
Phone: (386) 265-4360
NEWS
- Germfree Announces The Appointment Of Four Independent Board Members
- Germfree and Orgenesis Announce Asset Purchase And Strategic Partnership Intended To Revolutionize Cell And Gene Therapy Through Decentralized Production And Global Accessibility
- Germfree Laboratories And Title21 Health Solutions Transform Cell And Gene Therapy Manufacturing With Decentralized Innovation
- Novel Mobile Cleanroom Technology For Advanced Therapies
FEATURED ARTICLES
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![Germfree Feature]( "Optimizing Pharmaceutical Isolator Design")
Explore the importance of isolators in the pharmaceutical and biotech industries, the challenges of innovating aseptic isolator design, best practices, and key aspects of design optimization.
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![gettyimages-1273886962 therapeutics]( "Leveraging Tech, Regulatory Frameworks To Deliver Patient Access Today")
Amidst the shift toward decentralized manufacturing models, consider an approach that allows for standardized processes, remote monitoring and control, and centralized quality oversight.
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![Germfree construction 2]( "Choosing The Right Construction Method For Your Cleanroom")
Compare and contrast the different construction methods available for designing and constructing a cleanroom, including stick-built construction, modular panels, prefabricated modules, and more.
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![Getty-484225106- Balancing Speed-to-Market With A Risk-based Approach To Compliance]( "Balance cGMP And BSL-3 Regulatory Requirements")
Find the right solutions for your organization to comply with and maintain product quality and safety despite conflicting cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements.
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![Germfree laminar flow hoods]( "Laminar Flow Hoods In The Pharmaceutical And Compounding Industries")
Here, we compare and contrast horizontal and vertical airflow hoods and discuss their applications and benefits in the pharmaceutical and compounding industries.
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![Germfree guide passthrough]( "Guidance For Pass-Throughs In cGMP Cell And Gene Therapy Facilities")
How do active purging pass-throughs offer a higher level of material control for cell and gene therapy facilities?
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![Germfree design]( "Cell And Gene Therapy Facility Design Considerations")
Walk through 20 reasons why it's essential to establish a specialized cleanroom environment specifically tailored for your cell and gene therapy products.
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![Germfree passthrough]( "Effective Cleanroom Designs With Pass-Through Technology")
Delve into the key factors that determine flow, the influence of cleanroom classification, a hybrid approach to flow systems, and the advantages of some cleanroom pass-throughs.
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![Cleanroom bucket]( "Key Cleanroom Design Considerations For Drug Manufacturing")
Compare and contrast the pros and cons of several cleanroom design and construction methods to determine the most suitable approach for your specific project.
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![2 Cleanroom Scientists GettyImages-899692840]( "Expert Approaches To Pharmaceutical Containment Design And Facility Integration")
Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.
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![Scientist in cleanroom-GettyImages-854270370]( "Contamination Control Considerations For Cell And Gene Therapy Facilities")
Gain a thorough understanding of active HEPA purging pass-throughs along with the numerous benefits associated with their use in cell and gene therapy facilities for material control.
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![Scientists In Cleanroom GettyImages-1341292033]( "Best Practices For Sterile Fill Operator Gowning Training")
Sterile fill operators are crucial in ensuring pharmaceutical products are contaminant-free and safe for use. Explore best practices for sterile fill operator gowning training, mobile cleanroom benefits, and more.
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![Facility construction blueprints GettyImages-1398229122]( "Global EPCMV Firm And Cleanroom Vendor Deliver cGMP Virotherapy Facility")
A global EPCMV firm worked closely with a cleanroom vendor to deliver a manufacturing facility that meets guidelines for BSL2–Large Scale. Learn about the facility, the companies involved, and more.
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![cleanroom microscope lab iStock-1294339614]( "Designing A USP<797>/<800> Compliant Drug Compounding Facility")
Explore the essential components of cleanroom design necessary for Category 2 drugs to adhere to the updated stipulations within USP 797 / 800 chapters.
