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 and Calibrates Leaks in Vacuum Systems

The Telstar Leakstar Helium Leak Detection System is designed to ensure high precision and reliability in leak detection for gas insulated switchgear and automotive components. Utilizing a Mass Spectrometer Leak Detector directly connected to the vacuum line, it provides comprehensive vacuum evacuation and helium recovery. It’s engineered for both manual and fully automated operations, making it adaptable to any production line. Applications include gas insulated switchgear, automotive air conditioning systems, powertrain components, and more. The system supports integration with existing processes through high sensitivity detection capabilities of up to 10^-8 mbar·l/s. Additional features such as automated calibration verification and a helium recovery system improve environmental sustainability. Configured with a state-of-the-art PLC and touch screen interface, the Telstar Leakstar offers ease of use and programming flexibility, catering to customized industrial needs.

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Recovers and Purifies Industrial Helium Gas

The Helium Recovery System from Telstar is designed to address the rising helium costs and supply constraints by efficiently recovering and purifying helium gas across various industrial and laboratory applications. It integrates a helium compressor with optional flexible or rigid storage volumes and a high-pressure compression system. Notably, it features an online helium concentration meter to monitor gas purity and an optional dryer to eliminate moisture. This system boasts a greater than 95% recovery rate, making it ideal for operations requiring high-quality helium, including semiconductor manufacturing and MRI machine coolant replenishment. Additionally, it offers an intermediate solution, the Helium Economizer, for applications where a full recuperator isn’t justified, allowing recovery of up to 70% helium without requiring a compressor. The system is automation-ready with PLC control and remote connection capabilities, ensuring seamless integration into existing vacuum and processing setups. It meets the demands of the pharmaceutical, biotech, semiconductor, and aerospace industries, emphasizing sustainability and cost-effectiveness while adhering to industry standards.

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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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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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Ensures Sterility and Safety in Vaccine Production

The Telstar Class II Biological Safety Cabinet is designed to meet the stringent requirements of animal health companies and CDMOs for safe and efficient vaccine production. Featuring triple protection for product, user, and environment, it uses HEPA filtration to maintain clean airflow and sterility within the cabinet. Ergonomically designed for comfort and efficiency, it includes a height-adjustable work surface and reinforced trays to support heavy containers. Suitable for the production of veterinary vaccines and biologics, the cabinet supports both manual and semi-automated operations in pharmaceutical and biotech settings. It integrates smoothly into existing laboratory environments and complies with international safety and quality standards, ensuring reliable performance in Research & Development and pilot production phases. Customizable engineering options and comprehensive validation services ensure the cabinet meets your specific operational needs.

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Controls Environment and Isolates Laboratory Animals

The Rat and Mice Soft Pack Isolator, part of Shinva’s advanced laboratory solutions, ensures precise environmental control for biomedical research. Featuring H14 high-efficiency filtration and a PVC crystal construction, it maintains sterile conditions while offering easy access for operators. Designed for applications in biosafety and medical device isolation, it facilitates the controlled environment required for pharmaceutical and biotechnological research. Flexible integration into laboratory settings is supported by its mobile design and customizable configurations. With 304 stainless steel components for durability, the isolator aligns with industry standards, ensuring compliance and safety in rigorous research scenarios.

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Forms, Fills, and Seals Soft Bags

The Soft Bag FFS Machine from Shinva is engineered for pharmaceutical manufacturers requiring efficient production of large volume injections. It specializes in forming, filling, and sealing soft bags in a seamless process, ensuring sterile intravenous saline, dextrose, and nutritional bags. This machine operates on a continuous, automatic production line with a PLC-controlled system for precise, high-volume output.

Capable of integrating with upstream sterilization systems and downstream packing, palletizing, and warehousing steps, it offers a complete turnkey solution. Its energy-efficient design minimizes utility consumption, while sophisticated inspection systems ensure each product meets stringent quality standards.

Constructed from corrosion-resistant materials, the machine is GMP and FDA compliant, supports CIP (Clean-In-Place) for hygienic operations, and can be tailored to specific production needs with customizable configurations.

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Blows, Fills, and Seals Plastic Bottles

The Plastic Bottle BFS Machine from Shinva integrates blow molding, filling, and sealing into one seamless process for producing sterile liquid products. With its high automation and SmartPack features, it ensures efficient production of small volume injections like vaccine ampoules and sterile saline solutions. This equipment is ideal for pharmaceutical and medical device industries, offering reliable aseptic packaging with processing capabilities tailored to your needs. The BFS machine supports continuous operation under stringent GMP and FDA conditions, providing advanced leak detection and remote monitoring compatibility. Its robust construction in stainless steel options ensures long-lasting performance and minimal maintenance, making it a valuable addition to any facility focused on sterile production.

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