Ensures Aseptic Filling and Cross-Contamination Control

Developed by IMA Life, the ISOLATION TECHNOLOGY system is integral to aseptic fill-finish lines, particularly for pharmaceutical and biotech sectors. It minimizes human intervention with automated filling systems, ensuring sterility and containment for liquid and powder products like injectable vaccines and cytotoxic drugs. Leveraging cross-contamination control expertise, it integrates seamlessly into high-speed, continuous operations. Its robust design offers dedicated HVAC systems and customizable VPHP cycles, compatible with various isolators, vial washers, and alu-capping machines. The system’s energy-efficient components and remote monitoring capabilities enhance its operational efficiency, while its superior material options meet stringent GMP compliance standards. This system simplifies cleaning through integrated spray nozzles and CIP modes, supporting flexible configurations to suit specific processing needs.

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Facilitates Sterility Testing and Bio-Decontamination

The ISOTEST Sterility Testing Isolator from Getinge is engineered for precise sterility testing and bio-decontamination in pharmaceutical and biotechnological operations. This two-person isolator optimizes workflows, enabling continuous operations with dual-operator access. Designed to support diverse applications such as aseptic processing, cell culture, and gene therapy, it facilitates the production of sterile vials, pre-filled syringes, and more.

The isolator integrates a single Siemens PLC control system for process monitoring and offers SCADA integration, enhancing control and traceability. It boasts a high throughput of up to 40 tests per 8-hour shift with rapid bio-decontamination cycles using hydrogen peroxide vapor (HPV). The DPTE-BetaBag® system ensures safe waste handling without compromising isolator integrity. Its design meets industry standards for sterile environments, making it ideal for healthcare facilities, pharmaceutical manufacturers, and research labs.

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Maintains Sterility and Controls Contamination

The ISOFLEX Modular Aseptic GMP Isolator from Getinge is engineered to provide a robust solution for aseptic processing and contamination control in biopharmaceutical and pharmaceutical manufacturing. This isolator stands out with its modular design, allowing customization to fit specific process needs, including sterility testing, bio-decontamination, and repacking. Utilizing engineered turbulent flow or unidirectional airflow, it ensures precise environmental control, meeting Grade A/ISO 4.8 standards necessary for handling sterile APIs or personalized medicines.

The ISOFLEX efficiently supports high-throughput operations, integrating seamlessly into existing production lines with its PLC-based control system from Siemens or Allen Bradley. This system offers user-friendly interfaces for intuitive process monitoring and parameter adjustments. Energy efficiency is enhanced by focusing control within the isolator environment, reducing consumption compared to traditional cleanrooms.

Tailored for various applications, it finds use in producing monoclonal antibodies, insulin analogs, TPN admixtures, and more. The isolator is fully compliant with FDA 21 CFR Part 11 and GMP Annex 11, ensuring adherence to stringent regulatory standards. Optional features like bio-decontamination hatches and adaptable PLC systems underscore its capability to evolve with technological and process requirements, backed by engineering support for unique configurations.

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Ensures Sterile Containment and Decontamination

The FCIS Pharmaceutical Isolator from Fedegari is engineered to address the stringent requirements of contamination control in biopharmaceutical environments. This isolator utilizes Fedegari’s proprietary Hydrogen Peroxide Vaporizer (FHPV) to maintain sterile conditions essential for aseptic filling and handling of high-potent ingredients. It employs a barrier system to separate operators from sensitive processes, ensuring compliance with FDA and GMP standards. The FCIS is designed for high-value formulations like sterile injectable drugs and APIs for vaccines. Its modular design can be customized, and the Thema4 process controller facilitates integration with SCADA systems. The unit features AISI stainless steel chambers with a double-gasket system for safety and H14 HEPA filters for air filtration. Operating within a grade A environment, it minimizes cross-contamination risks and operational costs by excluding proprietary consumables.

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Performs Sterility Testing and Bio-Decontamination

The FCTS Sterility Test Isolator from Fedegari is an essential piece of equipment for pharmaceutical and biopharmaceutical manufacturers. Designed for precise sterility testing and effective bio-decontamination, it is ideal for handling injectable liquids, ophthalmic ointments, sterile antibiotic powders, and freeze-dried drugs. The FCTS employs H2O2 vapor phase technology, ensuring consistent biocide concentration levels within ± 15 ppm, which guarantees process repeatability and reliability.

This isolator operates under stringent cGMP guidelines and achieves ISO 5 FDA and Class A EU GMP classifications. Applications range from vaccine production to monoclonal antibodies, ensuring high integrity and compliance. Its modular design allows for custom configurations, including adjustable internal storage and racks. The integration with Fedegari’s Thema4 system facilitates seamless automation and compatibility with SCADA systems, reducing validation time and enhancing operational efficiency. The isolator is crafted with non-directional BA surfaces and features airtight doors with silicone inflatable gaskets for 100% air-tight operation. Made from robust stainless steel, it offers corrosion resistance and includes an internal trolley for material handling, promoting continuous loading operations.

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Controls Contamination and Provides Cleanroom Isolation

The FMF Unidirectional Flow Fan Filter Modules from Fedegari provide an essential solution for maintaining cleanroom environments essential in pharmaceutical and bio-pharmaceutical industries. This modular system utilizes vertical airflow to protect critical areas, ensuring ISO 5 cleanliness (Grade A – EU CGMP) by maintaining higher pressure inside the cleanroom than its surroundings, preventing contamination for processes such as injectable medication production and API isolation. With AISI 304 stainless steel casings, these units offer flexibility in installation, including options for suspension, ceiling grid mounting, or support legs. FMF integrates seamlessly with existing systems, allowing customizable configurations to meet specific production requirements.

Each module employs G3/G4 efficiency pre-filters, alongside H14 efficiency filters, optimizing airflow control and ensuring precise particulate containment. Designed for integration and customization, Fedegari’s FMF modules boast compliance with international standards, including GMP and FDA guidelines, ensuring safe and efficient operations across various applications. Enhanced energy efficiency is achieved through the use of efficient fans and adjustable airflow features, contributing to a reduced total cost of ownership. These units are perfect for pharmaceutical manufacturers concerned with maintaining stringent contamination control and sterile production conditions.

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Ensures Sterility in Testing Environments

The Sterility Testing Isolator from Fabtech Technologies is engineered for pharmaceutical, biopharmaceutical, and healthcare industries, offering a controlled aseptic environment for sterility tests and bio-decontamination processes. Constructed with durable SS 316L, it features ISO 5 Grade A laminar airflow, ensuring an ultra-clean workspace. Its standard setup includes a pass box with dual glove ports, a main chamber with quad glove ports, and a glove integrity tester, accommodating both manual and high-speed operations. Compatible with VHP decontamination, the isolator supports on-demand process equipment and particle counter integration, enhancing operational efficiency. Opt for multiple chamber configurations to tailor the isolator to your production needs. With password-protected authorization levels, it adheres to stringent compliance requirements, making it ideal for sterility testing of vaccines, monoclonal antibodies, and sterile medical devices.

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Controls Airflow and Environment in Cleanrooms

Fabtech Technologies introduces the Cleanroom Infrastructure System, a comprehensive HVAC solution tailored for pharmaceutical, biotech, and healthcare environments. This system specializes in delivering precise airflow control and environmental conditions necessary for producing vaccines, monoclonal antibodies, and sterile injectables. Utilizing a robust range of air handling units, it ensures constant temperature, humidity, and contaminant control through automated, modular operations. The system features a factory-installed, PLC-controlled management system that simplifies integration into existing processes, reducing installation time and costs. Designed to comply with stringent global standards like GMP and FDA, it offers customizable configurations to meet specific operational requirements. Constructed from durable materials with options for enhanced corrosion resistance, this infrastructure is engineered for continuous, efficient performance with minimal maintenance, supporting a seamless cleanroom environment critical for high-stakes production.

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Controls Environmental Conditions in Cleanrooms

Fabtech Technologies’ Modular Cleanroom Panel Systems epitomize adaptable and energy-efficient cleanroom solutions for the pharmaceutical, biotech, and healthcare sectors. Engineered to cGMP standards, these cleanrooms utilize prefabricated, scratch-resistant materials ensuring swift installation and minimal on-site fabrication. The panels, available in various insulation types like PUF, PIR, and Rockwool, offer densities ranging from 40 to 144 kg/m3, catering to specific project needs.

These systems excel in regulating airflow, temperature, humidity, and pressure, crucial for producing sterile injectable drugs, biopharmaceuticals, medical devices, and more. Fabtech’s design includes flush-fitted factory-installed windows and utility cavities for seamless integration of electrical and mechanical components, enhancing operational efficiency.

Incorporating Fabtech’s cleanroom systems into your facility facilitates compliance with stringent standards like BS 476 part b and Dubai Civil Defence fire ratings, ensuring safety and reliability in controlled environments. Custom-engineering options and engineering support make these systems versatile, allowing modification and reconfiguration to align with evolving operational demands.

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Ensures Sterility in Pharmaceutical Loading and Testing

The MSTI – Modular Sterility Testing Isolator from Comecer provides pharmaceutical manufacturers and radiopharmaceutical producers with a cutting-edge solution for ensuring sterility in a variety of applications. This modular system is specially designed for aseptic processing, offering flexibility with its customizable configuration to meet specific operational needs. It features a fully enclosed Grade A environment suitable for installation in Grade D areas. The MSTI integrates a vapor-phase hydrogen peroxide (VPHP) decontamination system that guarantees a 6-log reduction, ensuring thorough sterilization of all internal volumes with rapid cycle times.

Ideal for testing sterile injectable drugs, vaccine vials, and pre-filled syringes, the system supports various processes such as material loading, decontamination, and sterility testing. You can expect seamless integration within your production line as it operates continuously and is ready to use. Equipped with a peristaltic pump and racks for vials, ampoules, and other samples, the MSTI facilitates efficient handling and positioning of materials. The system boasts compliance with CFR21 Part 11, ensuring data integrity and meeting stringent pharmaceutical standards.

To boost efficiency, the MSTI features the Illuminate™ Manufacturing Intelligence platform, allowing real-time monitoring and data analysis to optimize production processes and minimize downtime. This isolator presents a robust solution for biotech, pharmaceutical, and hospital pharmacy sectors, offering reliability and versatility in demanding sterility testing environments.

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