Sterilizes Biopharmaceutical Products and Components

The FOF Saturated Steam Sterilizer by Fedegari is designed to meet the stringent requirements of the pharmaceutical and biopharmaceutical industries. This versatile sterilization solution excels in its ability to handle both solid and liquid products, such as vaccines, injectable drugs, and surgical instruments, with precision and reliability. Utilizing a sophisticated control system, the unit offers seamless integration into existing production lines, with both automatic and semi-automatic operations. Its stainless steel chamber, available in circular or square configurations, ranges from 200 to 6,800 liters and can be customized to fit specific throughput needs. The sterilizer ensures energy efficiency through optimized pressure control and maintains compliance with FDA and European standards, ensuring safety and reliability in critical applications. Maintenance is streamlined with Fedegari’s smart design, keeping downtime and operational costs low, while customizable engineering options allow for tailored solutions to your unique production requirements.

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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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Sterilizes and Conditions Liquid Pharmaceuticals

The SteriDelta W from Telstar is a superheated water shower sterilizer designed specifically for the sterilization of parenteral drugs and liquid pharmaceuticals in pharmaceutical and biopharmaceutical industries. This equipment leverages a high-flow recirculation system with a sanitary pump and heat exchanger to effectively sterilize, heat, and cool batches, ensuring containers emerge moist yet sterile. Ideal for processing liquid pharmaceuticals, the SteriDelta W showcases a compact and modular design, allowing seamless integration into existing production lines and ensuring compliance with European standards such as PED and CE marking. The design supports automatic operations and offers efficient sterilization cycles suitable for high-speed processing environments. Furthermore, its user-friendly features, including easy validation and maintenance, make it a versatile choice for demanding production conditions.

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Sterilizes Medical Devices Using Ethylene Oxide

The SteriEtox from Telstar is a sophisticated ethylene oxide sterilization system designed for the medical devices sector. It uniquely addresses the sterilization challenges of thermo-sensitive products such as syringes, catheters, and pacemakers by maintaining their integrity through precise ethanine oxide exposure. The system features an integrated process that includes preconditioning, aeration, and seamless loading and unloading operations, ensuring continuous and automated processing. With a focus on safety and efficiency, the SteriEtox is designed to comply with stringent regulatory requirements while offering flexibility through customizable cycles tailored to specific device configurations. This system supports parametric release, enhancing throughput in high-demand environments. Its construction boasts options for stainless steel components, ensuring corrosion resistance and durability, while Telstar’s engineering support provides tailored solutions to meet unique production needs.

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Performs Sterilization of Diverse Pharmaceutical Products

The SteriMega Plus from Telstar is a saturated steam sterilizer designed to handle a wide range of materials, including solid, porous, and liquid products, critical in pharmaceutical and biotech manufacturing. Its high-performance steam sterilization process conforms with GMP standards and European certifications like EN 285 and PED, ensuring regulatory compliance. With customizable options, this equipment offers versatility to address specific production needs, making it suitable for sterilizing ampoules, syringes, culture media, and more.

Incorporating advanced automation, the SteriMega Plus seamlessly integrates into existing production lines, offering PLC control for efficient operation. Its robust design supports batch, pilot, and continuous operations. Material options like stainless steel enhance durability and corrosion resistance. Equipped with a CIP (Clean-In-Place) system, it simplifies maintenance and ensures minimal downtime, solidifying its role as a reliable asset in ensuring sterility and product safety in critical production environments.

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Sterilizes and Dries Parenteral Liquid Products

The SteriDelta A from Telstar is a steam and air mixture sterilizer specifically engineered for processing large batches of parenteral solutions and diverse pharmaceutical products. It utilizes a modular and compact design facilitating seamless integration into existing production lines with minimal downtime. By incorporating an air recirculation system, the SteriDelta A ensures uniform steam and air distribution, effectively sterilizing and drying complex packaging formats such as pre-filled syringes and vials. This autoclave handles a range of liquid products including sterile saline solutions, injectable antibiotics, and monoclonal antibody therapies, maintaining compliance with stringent GMP and European regulatory standards. The system features automatic batch processing, enhanced by a user-friendly PLC-driven interface for robust control and monitoring. It is constructed with corrosion-resistant materials, offering durability and extended operational life, and is equipped with a CIP system to ensure efficient, contamination-free cleaning between cycles. Telstar provides engineering support for customizing solutions to meet specific production requirements, ensuring each unit is tailored for optimal performance in pharmaceutical and biotech manufacturing environments.

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Sterilizes and Depyrogenates Glassware and Products

The PyroMega Dry Heat Sterilization and Depyrogenation Oven from Telstar is your solution for precision thermal processing in sterile production environments. Specially designed for industries such as pharmaceuticals, biotech, and medical devices, this oven effectively sterilizes and depyrogenates materials like glassware, surgical instruments, and sterile saline solutions. Employing dry heat technology, it eliminates pyrogens on glass surfaces, vital for contamination-free products such as ampoules, syringes, and laboratory pipettes.

This equipment supports both batch and continuous operations, making it versatile for varying production scales. Integration with existing systems is seamless, thanks to its advanced PLC control that offers remote monitoring capabilities, ensuring seamless compatibility with your production line.

The oven operates with high energy efficiency, significantly reducing power consumption through optimized heating design. Built with durable materials, it withstands high temperatures necessary for depyrogenation, while meeting stringent GMP and FDA standards for quality assurance. Routine cleaning is simplified with its straightforward design, minimizing downtime and ensuring consistent performance.

Additionally, Telstar provides customization options, engineering support, and a comprehensive range of accessories such as custom-made trays and carts to tailor solutions to your exact needs. Align with Telstar for a sophisticated and reliable approach to sterilization and depyrogenation processes.

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Ensures Safe Containment and Sterility

Telstar’s Containment Isolators are engineered to deliver unparalleled safety and sterility for pharmaceutical and biotech operations. Designed to protect operators and ensure product integrity, these isolators are ideal for handling hazardous materials and sterile injectable drugs. They integrate seamlessly with existing systems and support both stand-alone and continuous operations. Telstar offers customizable designs, including single and multi-chamber options, tailored to client needs. The isolators boast positive and negative pressure capabilities and are constructed from standardized mechanical and electrical components for reliability. With rigorous OEL containment validation to less than 200 picograms/m³ (OEB 8), they comply with GMP and ISO standards, ensuring suitability for cleanrooms of grade D and above. Built in the UK, these isolators feature energy-efficient solutions and ergonomic designs, and they include worldwide maintenance services to support long-term use.

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Separates Operators from Critical Aseptic Environments

Telstar’s Restricted Access Barrier Systems (RABs) are designed to optimize aseptic processing by creating a high level of separation between operators and critical environments in pharmaceutical production. These systems are essential for manufacturing sterile injectable drugs, vaccines, and various biologics, offering a unique combination of physical barriers and dynamic airflow. RABs can be tailored to integrate with third-party equipment, ensuring compliance with GMP and current regulatory standards. They feature unidirectional laminar flow (active RABs) to maintain an ISO 5 positive pressure environment, crucial for protecting sensitive processes. With aseptic transfer capabilities for powders and liquids, and advanced environmental monitoring systems, these units are ideal for cleanrooms requiring enhanced sterility without the need for fully leak-tight isolators. Telstar supports customization and offers technical assistance, ensuring the RABs meet specific operational needs while facilitating ease of cleaning and maintenance through integrated systems.

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Facilitates Aseptic Sterility Testing

The Telstar Pura from Telstar is a precision-engineered sterility test isolator designed to create a reliable aseptic environment. What sets the Pura apart is its robust bio-decontamination system using ionHP+ H2O2, ensuring rapid Log 6 bioburden reduction. This isolator is ideal for pharmaceuticals and biopharmaceuticals, particularly in sterility testing of products like sterile injectables and vaccines. It features PLC control with local HMI and SCADA packages for seamless operation, integrating easily with OEM and third-party equipment. Constructed from durable 316 stainless steel and toughened safety glass, the Pura meets strict ISO and GMP guidelines, making it suitable for Grade D cleanrooms and above. The system supports direct inoculation and filter membrane tests while providing reliable environmental monitoring. Assembly and manufacture are conducted in the UK, ensuring compliance and a high standard of quality. Configuration options allow personalization to meet specific production needs, helping you maintain stringent aseptic standards with ease.

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