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Custom and Aseptic containment isolators

Custom and Aseptic containment isolators

Isolators are a core component to the pharmaceutical industry, critical for a range of processes. These gas-tight enclosures provide a complete barrier to ensure aseptic conditions and containment. Germfree manufactures advanced cGMP-compliant isolators to protect sterile products, personnel and the working environment. Germfree’s Aseptic Isolators are customized to meet the rigorous demands of your specific application and operate under positive pressure. Biopharmaceutical production often requires working with potent chemical APIs and hazardous biological agents. Germfree Provides Containment Solutions for All Types of Hazards – Chemical, Biological, Radiological and Volatile Compounds.

Custom Pharmaceutical Aseptic Isolators

Stringent aseptic conditions are essential to maintain quality control and meet FDA cGMP and other regulatory demands. Our Pharmaceutical Aseptic Isolators provide a complete barrier that separates and protects your product from personnel, other processes and the work environment.

Multiple-chamber Pharmaceutical Isolators
Germfree manufactures units with multiple chambers or isolator lines to separate your materials, processes and improve workflow. Filtration systems and airflow engineering controls are configured to prevent cross contamination or provide containment between chambers. This facilitates the handling and transfer of materials between barrier systems and allows sterile products to remain under isolation.

Contact Germfree to discuss your Pharmaceutical Isolator requirements.

Hazardous pharmaceutical processes can present a range of challenges. Risk agents associated with emerging therapeutics in the biologics arena must also be addressed. Containment isolators must effectively handle all types of hazardous agents. Germfree has been manufacturing advanced containment systems for more than five decades, earning a global reputation for engineering innovative solutions.

Germfree Pharmaceutical Isolator Open1

Germfree Pharmaceutical Isolator

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    Features

    General

    Applications

    • Fast-track design process; 3D modeling
    • 316L all stainless steel construction
    • Radiused corners and seamless surfaces allow for ease of cleaning and decontamination
    • Advanced ergonomics for the individualized requirements of your workflow
    • Integrated aseptic material transfer systems
    • On-board decontamination/sterilization
    • Controlled environments for specified set points including temperature and RH
    • System for continuous monitoring of critical conditions
    • IQ/OQ; complete documentation and validation package
    • Factory Acceptance Testing
    • Units meet or exceed all cGMP and other relevant standards and guidelines including: ISO classes, USP, GAMP 5, BSL and FDA CFR Title 21 Parts 210 & 211

    Pharmaceutical Isolator Types Include:
    Dispensing Isolators
    Transfer Isolators
    Sub-division and Weighing Isolators
    Cell Therapy – Cell Culture Isolators
    R&D Isolators and Class III Biosafety Cabinets
    Reactor and Charging Isolators
    Off-Loading Isolators
    Cytotoxic Compounding Containment Units
    Micronizing/Milling & Blending Isolators
    Pharmaceutical Isolators – Rigorous Engineering Standards and Features:
    Filtration systems to meet the required ISO class, biosafety or specialized levels of containment

    Units for Routine Aseptic Processes and Emerging Biopharmaceuticals
    Germfree’s cGMP-compliant systems provide the required combinations of functionality and protection. Our engineering specialists work with you to determine the optimal configuration:

    H-API Isolators – Safely handle highly potent, small molecule active pharmaceutical ingredients
    Custom Aseptic Process Isolators – Aseptic conditions for working with sterile products
    Biocontainment Isolators – Safely handle pathogens/biological risk agents
    Streamlined Manufacturing – Germfree Completes your Project Faster
    Our leading-edge fabrication technology, engineering team and subject-matter experts are all located on-site, in our US factory. We provide an efficient and collaborative design process and coordinate all logistics. From concept to completion, we deliver advanced solutions in an accelerated timeline.

    eXPLORE oUR hISTORY

    Creating Environments that Serve Life Science Innovation and Advance Global Health

    Germfree Provides Containment Solutions for All Types of Hazards: Chemical, Biological, Radiological and Volatile Compounds

    Germfree Pharmaceutical Isolator

    Germfree is known for constructing robust equipment with the finest stainless steel for easy cleaning.

    EXPLORE

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    Germfree BioPharmaceutical Trailer
    Pharmacy Trailer II at Sundown