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 Leaks and Fills Gas in Switchgears

The Leak Detection and Gas Filling Machine for Electric Switchgears by Telstar is engineered for full automation, combining helium leak detection and precision gas filling in a single integrated unit. This system achieves ultra-low tightness requirements, critical for the efficiency and safety of electric switchgear components such as vacuum circuit breakers and load break switches. Utilizing a multi-stage high vacuum system, the machine ensures sensitive detection at levels of 10^-7 mbar l/s through a quadrupole mass spectrometer.

Automatic loading and unloading streamline operations, reducing cycle times to an efficient 8 minutes per unit. An incorporated helium recovery system enhances operational sustainability by minimizing helium waste. Ideal for applications in the electrical, energy, and power generation sectors, this machine supports robust integration into final conditioning and processing departments, ensuring exceptional reliability and performance in demanding industrial environments.

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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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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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Ensures Aseptic Filling and Sterility

The Single Chamber 4 Glove Aseptic Isolator from Telstar is engineered for pharmaceutical and biotechnology applications requiring stringent aseptic conditions. This isolator features an integrated H2O2 bio-decontamination system, ensuring a contamination-free environment for the production of preservative-free eye drops, sterile APIs, and injectable syringes. The system’s single working chamber, equipped with adjustable height and comprehensive viable and non-viable monitoring, allows precise handling of pharmaceutical processes. Its automation capabilities, reinforced by integrated monitoring, support seamless insertion into existing production lines, optimizing both throughput and sterility assurance. Constructed with corrosion-resistant materials, the isolator meets GMP standards and is designed for ease of cleaning and maintenance, offering long-term reliability and efficiency in sterile manufacturing environments.

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Fills and Seals Vials and Syringes Aseptically

The Aseptic Vial and Syringe Filling Isolator Lines from Telstar offer an integrated solution for pharmaceutical manufacturers, ensuring sterile filling and sealing of vials and syringes. These lines feature a multi-chamber isolator system that maintains sterility with HEPA-filtered laminar airflow and are designed for both batch and continuous operations, minimizing contamination risks. Ideal for producing lyophilized monoclonal antibodies, vaccines, and sterile solutions, these isolators handle both liquid and solid forms with high precision. The system supports integration with upstream and downstream processes, such as lyophilization and packaging, and is controlled via a PLC for seamless operation. Constructed in stainless steel to withstand rigorous cleanroom conditions, the isolator lines comply with GMP standards, offering automated cleaning processes for efficient maintenance. Custom engineering support is available to tailor the equipment to specific production needs.

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Fills Lyophilized Pharmaceuticals with Precision

The Sterile Lyophilised Filling Line from Telstar is designed specifically for pharmaceutical and biotech manufacturers, ensuring sterile and precise filling of lyophilized pharmaceuticals such as monoclonal antibodies and injectable drugs. This engineered-to-order system features a multi-chamber design that facilitates seamless integration into existing production lines, addressing stringent regulatory requirements with GMP compliance. The line’s high-accuracy weighing and filling capabilities ensure consistent dosing, minimizing product wastage and contamination risks. With automated PLC controls, it allows for remote monitoring and integration with upstream and downstream processes. Constructed from high-grade stainless steel, it offers excellent corrosion resistance and is equipped with a CIP system for efficient cleaning, reducing downtime and ensuring continuity in production. Customizable elements, such as chamber sizes and throughput rates, ensure that the system can be tailored to your specific production needs, accommodating various pharmaceutical powders, lyophilized vaccines, and controlled-release formulations.

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Unloads and Isolates Lyophilised Products

The Two Lyophiliser Unloading Isolators from Telstar offer specialized solutions for handling and unloading hygroscopic products post-freeze drying. These isolators are designed to provide low moisture control using dry N2 with precise dew point regulation. Ideal for pharmaceutical manufacturers and biotech companies, the equipment ensures safe manipulation of lyophilized vaccines, drugs, sterile injectables, and aseptic vials. With a structure comprising a left-hand chamber, middle pass chamber, and right-hand chamber, each with multiple glove ports, it facilitates seamless operation and prevents contamination. Fully compliant with GMP standards, these isolators support integration into existing aseptic and multi-chamber operations, offering engineering support for custom configurations.

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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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