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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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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Executes Precise Lyophilization for Vaccine Stability

The Lyophilization Freeze Dryer from Telstar is designed for the precise and efficient lyophilization of vial-encased live attenuated bacteria vaccines. This equipment operates with a mushroom-type chamber-condenser and SCADA-controlled environment, ensuring seamless integration into automated production lines. It supports pharmaceutical and biotech sectors, providing critical freeze drying for applications such as anticancer and innovative drug formulations. With a capacity of two 10 m² freeze dryers and 200 kg ice condenser support, the system’s batch processing capability ensures high-throughput operations. Constructed for durability, under stringent GMP compliance, it features CIP/SIP systems for effective cleaning and maintenance, maintaining high hygiene standards for sensitive product handling.

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Monitors Sublimation Front Advancement in Real-Time

The Telstar Sublime is a real-time sublimation front monitoring system designed for pharmaceutical and biotechnology industries. This innovative system employs single-use wireless probes to track the sublimation front temperature interface during freeze-drying. It excels in optimizing cycle development by providing accurate multipoint temperature readings, thus enhancing process understanding and repeatability. Key applications include the production of monoclonal antibodies, lyophilized vaccines, and vitamin tablets. The Sublime integrates seamlessly with automatic loading and unloading systems, reducing logistics complexity and cross-contamination risks. It is fully compliant with cGMP and FDA 21 CFR Part 11 standards, ensuring the highest level of quality control for your operations.

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Efficiently Freeze-Dries and Preserves Samples

The LyoAlfa Laboratory Freeze Dryer from Telstar is designed to meet the specific needs of research centers and production facilities in biotechnology, pharmaceuticals, and food industries. It features a user-friendly interface that facilitates the development of lyophilization protocols, crucial for preserving product stability across various applications. This freeze dryer can handle substantial sample volumes with its 22 kg condenser capacity and achieves final condenser temperatures of -83ºC ±3ºC. It integrates seamlessly with laboratory settings, featuring the LyoLogger data acquisition software for enhanced monitoring and control. Customizable with various accessories, it supports a wide range of materials, from active pharmaceutical ingredients to preserved botanical extracts. Made for easy installation and use, the LyoAlfa is ideal for bench-top, batch, and manual operations, ensuring efficient freeze-drying backed by comprehensive technical support from Telstar. This model complies with stringent laboratory standards and emphasizes flexibility with the option of heated shelves for specific drying needs.

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Facilitates Safe and Custom Drug Preparation

The Hospital Pharmacy Laboratory range from Telstar includes specialized drug preparation cabinets like the Aeolus H IT and Bioptima models. These solutions are engineered for the intricate needs of hospital pharmacies and pharmaceutical manufacturers, offering advanced laminar flow and biological safety features crucial for the preparation of personalized medicines, including cytotoxic and customized drugs. These cabinets utilize HEPA-filtered airflows to create sterile environments, essential for maintaining product integrity and operator safety during drug formulation. Common applications include chemotherapy drug production and individualized vaccine preparation. The units are designed for efficient batch processing, with easy integration into existing laboratory workflows. Optimized for energy efficiency, these cabinets adhere to strict GMP and FDA standards, providing reliable compliance in pharmaceutical environments. Maintenance is simplified through easily accessible filters and modular design, ensuring long-term operational effectiveness. Customization options are available to meet unique client specifications, supported by Telstar’s comprehensive engineering support.

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