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 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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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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Ensures Sterile Environment for Drug Production

The Aseptic Barrier Isolators from Telstar are designed to meet the stringent demands of pharmaceutical and biotech production. These isolators are crucial for maintaining sterility in processes involving vaccines, oncology drugs, and protein-based biologics. The system incorporates advanced filtration and environmental monitoring to ensure compliance with ISO and GMP guidelines. Constructed from 316 stainless steel and toughened safety glass, these isolators offer robust protection against contamination while facilitating aseptic transferring and bio-decontamination. Capable of integrating with OEM and third-party equipment, the isolators support seamless production line automation and high-speed operations. With validated Log 6 bio-decontamination and options for customizing airflow systems, Telstar provides tailored solutions that enhance product and operator safety, reduce downtime, and ensure regulatory compliance.

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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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