Sterilizes and Dries Pharmaceutical and Medical Packages

The GEV Steam/Air Mixture Sterilizers from Getinge provide a solution for pharmaceutical manufacturers and healthcare facilities focused on sterilizing complex package-product combinations. These sterilizers use a steam and air mixture process, ensuring uniform temperature and pressure to maintain package integrity. Their applications span sterilizing items like vaccine vials, prefilled syringes, and flexible IV bags. With a wide range of chamber sizes from 0.36m³ to 16.3m³, they cater to varied production requirements. These units offer automated features like conveyor systems and robotic handling, enhancing throughput and reducing manual handling errors. A key highlight is the integration of sterile compressed air to maintain pressure balance and rapid cooling technology using heat exchangers, which prevents package deformation while ensuring products are cooled and ready for subsequent processes. The sterilizers are cGMP compliant and can be equipped with single or double doors for easy installation in various production setups. For further customization, Getinge provides engineering support to optimize sterilization cycles and accommodate unique production needs.

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Ensures Sterilization and Biocontainment in Laboratories

The GSS R Steam Sterilizer from Getinge is engineered for biomedical research and laboratory settings, offering robust sterilization and decontamination solutions. Crafted with a stainless steel design, it ensures reliable containment and operator safety, tailored for various biosafety levels. Its working principle involves efficient steam sterilization, ideal for applications such as sterilizing biological samples, research animals, and lab equipment. Available in sizes ranging from 0.4 to 9 cubic meters, it supports customizable operations. Incorporating an intuitive HMI, it seamlessly integrates into laboratory lines, offering high precision in manual or batch modes. Its energy efficiency and compliance with industry regulations make it a sustainable choice for life science and healthcare facilities, with support for additional sizes and advanced features on request.

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Sterilizes and Validates Pharmaceutical Components

The GSS P Steam Sterilizer from Getinge is engineered to meet the stringent demands of the pharmaceutical and biopharmaceutical industries. This autoclave stands out with its reliable contamination prevention and user-friendly operation. Employing a controlled steam sterilization process, it facilitates batch, high-speed, and continuous operations, perfectly suited for applications involving injectable vaccines, sterile saline solutions, and lyophilized drugs.

Designed with flexibility in chamber sizes ranging from 0.4 to 9 cubic meters, it integrates seamlessly into various production environments. The intuitive HMI and SIMATIC WinCC Unified enhance operator control and monitoring, promoting ease of use and safety. With materials crafted from GMP-compliant, sanitary stainless steel, the GSS P ensures hygiene and durability, while robotic welding and polishing guarantee superior finish and corrosion resistance.

Configured for global compliance, it supports GAMP5 validation and adheres to GMP standards, ensuring certification across diverse regulatory landscapes. The integrated Quality Process Management System facilitates seamless validation and monitoring, while options such as B & R, Siemens, or Allen Bradley control systems provide versatile automation and integration capabilities. Getinge further offers extensive customization and engineering support to optimize configuration and operational efficiency.

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Transfers and Contains Sterile and Hazardous Materials

The DPTE® Beta Containers from Getinge are engineered for critical sterile and hazardous material transfers in pharmaceutical and biotech industries. These containers utilize a locking mechanism that ensures seamless bi-directional flow while maintaining containment, critical in aseptic environments. Designed for applications like vaccine and monoclonal antibody production, they support a range of processes, including sterilization and biodecontamination. Compatible with DPTE® Alpha Rapid Transfer Ports, they prevent microbial contamination during material transfers. Offering material options like stainless steel for steam sterilization and polyethylene for gamma or H2O2 sterilization, the containers meet stringent industry standards while ensuring operational efficiency. Options for modular configurations and custom engineering support ensure adaptability to diverse production needs. With autoclavable and configurable options, DPTE® Beta Containers deliver a reliable solution for maintaining sterile conditions in complex production lines.

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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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Detects High-Pressure Leaks in Components

The High Pressure Leak Detection System with Robot Loading by Telstar is an essential component for industries such as automotive, aerospace, and electronics. It specializes in identifying leaks in components subjected to pressures up to 380 bar(a), using a highly sensitive detection capability of 10-6 mbar l/s through a Quadrupole Mass Spectrometer. Equipped with a fully automated, high-speed cycle time of 20 seconds, the system is seamlessly integrated into your production line, ensuring efficient loading and unloading via robotic systems. This machine is perfect for testing engine blocks, electric switchgear enclosures, and satellite components. The inclusion of a multi-stage high vacuum and integrated helium recovery system not only enhances detection accuracy but also promotes environmental sustainability. Constructed for continuous operation, it offers robust performance with minimal downtime, catering adeptly to the rigorous demands of high-volume production environments.

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Simulates Space Conditions for Satellite Testing

The Medium Size TVAC from Telstar is a 1.3m diameter thermal vacuum chamber ideally suited for testing satellite components. It recreates the harsh conditions of space, with a temperature range from -150°C to +150°C and a vacuum level below 10^-6 mbar. This chamber supports precise temperature and vacuum simulations, critical for ensuring component reliability in aerospace applications such as satellite payloads, antennas, and battery systems. Each chamber is equipped with independently controlled shroud and baseplate systems, enhancing testing accuracy. Designed for integration into research and development labs, it features an LN2 temperature control system and can be customized for different testing needs. Its construction ensures robustness against corrosive elements, with strong support from Telstar’s engineering team to tailor configurations.

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Performs Sterile Freeze-Drying for Biopharmaceuticals

The Lyogistics Zero, offered by Azbil Telstar, stands out as a vital asset for pharmaceutical manufacturers and biotech companies seeking precision in sterile lyophilization. This system integrates seamlessly into your existing production lines, using a vertical two-storey configuration to maximize space efficiency while maintaining high capacity with four lyophilizers and a 30 m² ice condenser capable of handling 600 kg. This versatile solution is designed for a range of biopharmaceutical processes including monoclonal antibody purification and high potency API treatments. Engineered for robust containment, it includes mushroom-type isolation valves and full compatibility with toxic and flammable solvents. Efficiency is further enhanced by the inclusion of dry vacuum pumps and an advanced CIP/SIP protocol for contamination-free operations. It meets stringent GMP and FDA guidelines, ensuring compliance and product integrity. Customize the system to fit your operational needs, with options for automatic loading and unloading via the Lyogistics Zero pass-through system, which enhances productivity and maintains a cleanroom environment.

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Processes and Lyophilizes Aseptic Vial Fillings

The Sterile Lyophilised Vial Filling Line from Telstar offers cutting-edge solutions for pharmaceutical and biotech companies needing precision in aseptic processing. This line integrates seamless vial filling with advanced lyophilization, ideal for high-potent drugs like monoclonal antibodies and mRNA vaccines. Featuring an automatic row-by-row single-side push-in/pull-out system, it ensures efficient loading and unloading. The system incorporates SCADA for comprehensive process control and real-time monitoring, optimizing production efficiency. Designed with a mushroom-type chamber-condenser isolation valve, it excels in solvent handling and vacuum processing, minimizing contamination risks. The equipment meets stringent GMP standards, ensuring compliance for pharmaceutical applications. With integrated CIP and SIP systems, it offers enhanced cleaning and sterilization efficiency, reducing downtime and ensuring product safety. Customization options cater to specific production needs, supported by expert engineering support from Telstar.

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Sterilizes Medical Devices and Hygroscopic Products

Ethylene oxide sterilization chambers from Telstar provide crucial sterilization solutions for the pharmaceutical and medical device industries. These turnkey chambers use ethylene oxide gas and vaporization for a thorough sterilization process, ensuring the safety of medical devices, intravenous solutions, and lyophilized vaccines. Featuring an automatic loading and unloading system, these chambers integrate seamlessly into production lines. Equipped with a SCADA system, they offer precise control over preconditioning, sterilization, and aeration phases. Their robust design supports compliance with strict GMP standards, and they include options for customizing chamber size and configurations to meet specific operational needs. The system’s connection to air purification systems ensures operator safety and environmental compliance, making it an essential component in maintaining sterile production environments.

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