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

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.

All stainless steel, lead shielded USP <825> compliant biosafety cabinet.

Germfree’s Powder Weigh Hoods are laboratory workstations designed to provide a clean and sterile environment for powder handling procedures. The hoods are designed to filter air, eliminating airborne contaminants such as dust, particles, and microorganisms that may affect the quality of the powder being handled.

Solutions for rapid response to vaccine development and manufacturing challenges

Vaccine development trends emphasize the need for adaptability and accessible production facilities. Remote manufacturing tackles these challenges, facilitating decentralized vaccine production and rapid responses to health crises. Germfree, a leading cleanroom manufacturer, remains at the forefront of these trends by providing configurable solutions that satisfy regulatory requirements and end-user needs. By leveraging innovative remote manufacturing technologies, Germfree helps shape a more dynamic and efficient future for vaccine development and production.

Germfree understands the unique challenges associated with 503B sterile drug compounding

Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.

Delivering on the promise of cell and gene therapy through Germfree products and services.

Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.

Delivering on the promise of cell and gene therapy

Germfree is a leader in creating mobile and modular facilities specifically for cell and gene therapy (CGT) manufacturing. As CGT sits at the crossroads of medical research and pharmaceutical development, it demands highly specialized cleanroom designs. These designs must focus on efficient workflows, strict separation procedures, and rigorous aseptic processing to ensure the best results. Despite the quick growth and logistical challenges in the CGT field, Germfree’s mobile solutions effectively tackle these issues. They enable distributed manufacturing, ease the collection of patient cells, and help make CGT treatments accessible globally.

Viral vector manufacturing: key to successful gene therapy

Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.

Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward

Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.

Navigating the technical challenges of mAbs production and scalability

Monoclonal antibodies (mAbs) offer promising immunotherapy treatments, targeting antigens and diseases. Manufacturing these complex therapies presents challenges in scaling up, cost, and consistency. Germfree’s expertise in tailored cleanroom solutions addresses these obstacles, ensuring sterility and seamless equipment integration. By providing advanced facilities for both small-scale clinical trials and larger-scale production, Germfree contributes to the successful development and commercialization of mAbs, ultimately improving patient outcomes and transforming healthcare landscapes.

Revolutionizing Global mRNA Production: Germfree's Innovative Cleanrooms Drive Manufacturing Success

Cleanroom requirements for mRNA manufacturing encompass stringent particle control, temperature and humidity management, solvent management and robust contamination prevention strategies. Germfree’s advanced cleanroom solutions address these challenges, ensuring seamless equipment integration, process adaptability, and compliance with regulatory standards. Their tailored mobile and modular facilities support the emerging trend for localized vaccine production, empowering biopharmaceutical companies to harness the transformative potential of mRNA technology in a rapidly advancing field, and ultimately contributing to global immunization efforts.

Premium Quality, Superior Product Protection

Our Horizontal Laminar Flow Hoods are USP <797> compliant and designed for the handling of sterile products in an aseptic working environment. The work area is continuously bathed with positive pressure ISO 5/Class 100 horizontal laminar flow air that has passed through a High Efficiency Particulate Air (HEPA) filter. This filter removes organisms and particulates 0.3 micron in size with an efficiency of 99.99%. The laminar airflow principle consists of moving individual streams of unidirectional, ultra-clean air along parallel lines with minimal turbulence. The HEPA filter is positioned in the rear of the work area and is protected by a removable, perforated metal diffuser.

​Critical environments for aseptic processing and filling

Aseptic processing is a vital aspect of sterile pharmaceutical manufacturing that requires stringent environmental controls, specialized equipment, and well-trained personnel. The equipment used in aseptic processing is designed for easy cleaning and sterilization. Commonly used devices include laminar flow hoods, isolators, filling machines, and sterile filtration systems. These systems work together to provide a controlled, contamination-free environment for drug production.

The newly redesigned equipment includes Laminar Flow Hoods, Biological Safety Cabinets, and Cleanroom Pass-Through Boxes. These new products build on Germfree's 60 years of aseptic PEC expertise in both the hospital compounding and pharmaceutical industries. The equipment has been designed to meet and exceed the strict cGMP and USP <797>/<800> regulatory requirements found in these industries.

Germfree’s Compounding Pharmacy equipment and bioGO® Mobile, Modular Pharmacies are Offsite-built, Compounding-ready and available in standard and custom configurations, for sale or lease.

CONTACT INFORMATION

Germfree

4 Sunshine Blvd

Ormond Beach, FL 32174

UNITED STATES

Phone: (386) 265-4360

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