Fills and Seals IV Bags Aseptically

The VarioSys® from Harro Höfliger is a modular aseptic filling system designed for pharmaceutical and medical device manufacturers requiring precision and sterility in their production processes. This system excels in aseptic filling and sealing of IV and infusion bags, using a flexible trolley system that enables swift process changes. It incorporates nitrogen or argon rinsing, integrated evacuation, gassing, and CIP-SIP capabilities, making it ideal for sterile and contamination-free operations. With applications ranging from saline IV bags to chemotherapy solutions, the VarioSys® ensures exact dosing accuracy—ranging from 50 ml ± 1.5% to 5,000 ml ± 0.3%—under GMP-compliant conditions. The system supports semiautomatic operations and is perfect for small batch production and laboratory settings. It features a unique “lock and key” modularity that facilitates rapid replacement of dosing processes, reducing downtime. The devices are built with options for ultrasonic and laser welding assemblies, catering to diverse production requirements while achieving seamless integration in existing production lines. Compliant with stringent industry standards, it offers efficient cleaning and maintenance capabilities, enhanced by its CIP (Cleaning in Place) system, which ensures a sterile environment between production cycles.

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Synthesizes and Dispenses Radiopharmaceuticals Safely

The PHAEDRA COMBO Series from Comecer is a versatile shielded isolator specifically designed for the synthesis and dispensing of radiopharmaceuticals and aseptic pharmaceutical products. What sets this equipment apart is its combination of modular design and strict adherence to cGMP standards. The system seamlessly integrates a synthesis and dispensing chamber, allowing for precise production and containment of various isotopes such as FDG, Iodine-123, and more. With a synthesis capacity maintained under Class B conditions and dispensing under Class A laminar airflow, it ensures the highest purity levels. The isolator’s compact design is ideal for small laboratory spaces, while its ergonomic features and the tele-plier handling system provide safe, efficient operations. Certified with advanced decontamination features and designed for ease of cleaning, the PHAEDRA COMBO Series offers a reliable solution for pharmaceutical manufacturers, nuclear medicine facilities, and hospital pharmacies seeking state-of-the-art radioprotection and operational excellence.

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Dispenses and Calibrates Radiopharmaceuticals Safely

The Radiopharmaceutical Dispensing Isolator PHAEDRA from Comecer offers a specialized solution for handling and dispensing sensitive radiopharmaceutical compounds. PHAEDRA stands out for its dual-stage dispensing and calibration system that maintains sterility and safety, making it ideal for producing Fluorodeoxyglucose (FDG), Gallium-68 radiotracers, and more. Equipped with a Class A chamber, it supports a laminar flow environment crucial for contamination control. This isolator is optimized for batch and continuous operations, featuring both manual and high-speed processes. Integration with GMP lines is seamless, with a user-friendly touch panel for precise control. Fabricated with 316L stainless steel, it offers excellent corrosion resistance, catering to the demanding environments of nuclear medicine and pharmaceutical compounding. Fully compliant with GMP standards, PHAEDRA ensures minimal downtime through its efficient waste management and swift decontamination capabilities, including an optional VPHP system for thorough sterilization. Whether you’re in medical research or a hospital pharmacy, PHAEDRA provides comprehensive solutions for radiopharmaceutical applications.

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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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Synthesizes and Dispenses Gallium-68 Radiopharmaceuticals

The MUSA 68Ga Shielded Isolator from Comecer is designed to streamline the synthesis and dispensing of Gallium-68 radiopharmaceuticals. Featuring a modular design, it allows for flexible configuration to meet the specific needs of nuclear medicine and pharmaceutical applications. The isolator operates under aseptic conditions, aligning with cGMP standards for handling beta and gamma-emitting radiopharmaceuticals, including Lutetium-177 and Yttrium-90. It integrates seamlessly through its multi-functional compartments for synthesis, calibration, and fractioning processes, all of which are protected by 50 mm Pb shielding for superior radiation safety. Automation is achieved via a touch-screen console and dose calibrator, ensuring precise dispensing. The isolator is compliant with Good Radiopharmacy Practices, enhancing safety and efficiency in complex radiopharmaceutical operations while offering custom engineering support for specialized applications.

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Handles and Isolates Cytotoxic Substances Safely

The Isolator for Cytotoxic Manipulation from Comecer provides a secure environment for the preparation and handling of cytotoxic drugs, chemotherapy medications, and advanced therapy medicinal products. This compact unit is ideal for research and development laboratories where containment and operator protection are crucial. Featuring a glovebox design, it uses negative pressure and HEPA H14 filtration to maintain Class A or ISO 5 cleanroom conditions, ensuring the integrity of sensitive pharmaceutical compounds and radiopharmaceuticals like Doxorubicin and Lutetium-177. Fully PLC controlled, it integrates seamlessly into R&D operations, supporting automated handling processes with options for bag-in/bag-out exchanges and VPHP connections for decontamination. Compliant with EC-GMP standards, this isolator is engineered for both liquid and solid product types, offering a customizable solution to meet your specific requirements.

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Processes and Fills Vials and Syringes Aseptically

The HELIOS High-throughput Aseptic Isolator, from Comecer, is engineered for precise filling and calibration of vials and syringes in aseptic conditions. Designed for pharmaceutical and radiopharmaceutical production centers, it supports applications such as producing radiolabeled tracers, sterile injectables, and monoclonal antibodies. This automated system can process batch sizes effectively with an average speed of one unit every 75 seconds. Integration into existing production lines is seamless, featuring an invisible conveying system and magnetic transport for precise movement. HELIOS operates under cGMP guidelines, equipped with Class A laminar flow, and offers comprehensive sterilization and leak testing. Constructed with options for lead shielding and equipped with a HEPA filtration system, it supports strict contamination control measures. Maintenance is streamlined through its easy-clean design and features such as a semi-automatic Bubble Point Test. Tailored engineering options allow for customization to meet specific operational needs while adhering to stringent industry compliance.

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Fills, Assembles, and Sterilizes Pharmaceutical Products

The SuperTrak PHARMA8™ from Comecer and ATS is an engineered-to-order sterile filling and aseptic isolator system that stands out for its integration of advanced asynchronous linear motion technology. This system excels in aseptic filling and assembly, efficiently processing pharmaceutical vials, prefilled syringes, IV infusion bags, and more, while complying with cGMP, FDA, CE, and UL standards. Utilizing a state-of-the-art isolator with Grade A air quality, it reduces particle generation and eliminates manual intervention, achieving speeds up to 2.5 m/s. Its automation level includes minimized moving parts to enhance reliability and energy efficiency. The system’s versatility supports a wide range of applications across industries like pharmaceuticals, biotech, radiopharma, and cell and gene therapy, making it an ideal choice for high-speed, continuous manufacturing. Comprehensive engineering support ensures seamless integration and customization, meeting the specific production line requirements of pharmaceutical manufacturers and related sectors.

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Maintains Aseptic Conditions for Cell Culturing

The Cell Culture Isolator from Comecer is expertly designed to maintain sterile environments essential for regenerative medicine and tissue engineering. This isolator features a fully PLC-controlled system offering automated decontamination through a Vapor Phase Hydrogen Peroxide (VPHP) generator, ensuring a safe and clean workspace for handling sensitive cell cultures and biologic drugs. Equipped with laminar airflow and positive pressure maintenance, it provides an ideal setting for laboratory-scale operations in pharmaceutical and biotech industries. The isolator includes a high-grade stainless steel construction with a fully welded chamber, enhancing durability and corrosion resistance. Compliant with GMP guidelines, the system supports processes such as centrifuging and material introduction, vital for applications like stem cell therapies and CAR-T cell treatments. Integration into existing production lines is seamless thanks to its friendly HMI interface, while its compact design allows for easy cleaning and low-maintenance operation, ensuring optimal functionality and longevity.

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Processes Cytotoxic and Hygroscopic Pharmaceuticals Safely

The Freeze Dryer & Aseptic Isolator Filling Line from Telstar is engineered to meet stringent pharmaceutical and biotech production needs. This integrated system performs critical tasks such as filling, lyophilization, capping, and crimping of cancer treatment vials and cytotoxic injectables while ensuring aseptic conditions. It employs a sterile multi-chamber configuration with VHP biodecontamination and advanced monitoring systems to maintain operator safety and product integrity. Designed for high potency and hygroscopic products, this equipment handles both batch and continuous operations with precision. It features cold shelf loading and low-temperature air handling units for effective lyophilization, ensuring the stability of delicate compounds. The inclusion of RFID glove testers and advanced isolation units supports seamless integration into existing lines, while compliant with GMP standards. The use of stainless steel construction enhances durability and corrosion resistance, reducing maintenance burdens and ensuring longevity.

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