Fills and Seals Pre-Filled Syringes

The Syringe Filling Machines from Syntegon streamline your production line, integrating automation to handle sophisticated processes such as de-nesting, filling, closing, and inspection. Specializing in high-value biopharmaceuticals and parenteral drugs, these machines ensure precision in both liquid and lyophilized forms. Capable of high-speed and continuous operation, they maintain sterility by minimizing operator intervention, using PLC-controlled technology for seamless integration into existing systems. Available with options for barrier systems and aseptic transfer, the machines support compliance with GMP standards, providing safe handling for injectable hormones and recombinant proteins. Equipped with automatic clean-in-place (CIP) systems, maintenance is simplified, ensuring reliable operation with minimal downtime. Custom configurations are available to suit specific manufacturing needs, backed by engineering support for optimal integration.

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Processes and Sterilizes Liquid Parenteral Pharmaceuticals

The SVP Essential and LVP systems from Syntegon provide modular solutions tailored for liquid pharmaceutical manufacturing. Designed for flexibility, these systems handle mixing, homogenizing, and filling of both small and large volume parenterals. With capacities ranging from 13 to 20,000 liters, they integrate seamlessly into production lines through automation, enabling efficient batch and continuous operations. These systems feature robust CIP/SIP capabilities, ensuring rapid, contamination-free cleaning. Constructed with stainless steel, they comply with GMP and FDA standards, making them ideal for antibiotics, infusion solutions, and cell culture media production. The prefabricated cleanroom design reduces installation time and guarantees a minimal footprint, adapting to various production requirements. With over 70 pre-tested modules and ISA-88 structured automation, Syntegon’s solutions ensure process precision and operational control.

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Enables Precise Dosing and Continuous Production

The Xelum Continuous Manufacturing Platform from Syntegon is a transformative solution for the pharmaceutical and nutraceutical industries, offering seamless integration of precise dosing and continuous production for oral solid dosage forms. By leveraging discrete mass dosing, the Xelum platform eliminates the need for traditional scale-up, ensuring high content uniformity even for APIs below 1%. This system is ideal for producing a variety of products such as antibiotic tablets and antiviral capsules, thanks to its robust fluid bed processors that handle granulation and drying in a single chamber, avoiding wet granulate transfer and enhancing reliability. With throughput capacities ranging from 10 to 100 kg/h, Xelum supports rapid production cycles and maintains exact standards in API concentration.

The platform is fully automated, featuring PLC-controlled operations with direct process parameter transfers from R&D to production, allowing for efficient pilot and clinical trials without the constraints of scaling up. It accommodates complex formulations with contained capabilities for OEB4 materials and integrated WIP systems. Xelum’s design prioritizes energy efficiency, reducing production costs while maintaining flexibility for both tablets and capsules. Engineered to meet stringent GMP and FDA standards, it offers a clean-in-place (CIP) system ensuring fast, contamination-free cleaning, perfect for high-potent API development. Customization support allows for tailored configurations to suit specific manufacturing requirements, making Xelum a cornerstone for forward-looking production strategies.

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Fills and Seals Vials for Liquid Pharmaceuticals

The FLC 3000 from Syntegon is designed to efficiently fill and seal vials in liquid pharmaceutical production lines, particularly for high-demand products like Covid-19 vaccines and monoclonal antibodies. Its compact GMP-compliant design supports a wide filling range of 0.2 to 500 milliliters and achieves throughput of up to 600 vials per minute, reducing changeover times with only three format part sets required. The machine’s peristaltic pump technology ensures precise dosing while maintaining sterility, and it integrates seamlessly into production environments with options for full in-process control. A clean and hygienic design facilitates easy maintenance and operator safety, meeting stringent GMP and FDA requirements. The FLC 3000 can be customized with additional filling technologies and systems as needed, providing robust support for both batch and continuous operations.

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Detects Particulate and Cosmetic Defects

The AIM 8000 series from Syntegon represents cutting-edge technology in automated visual inspection systems. These machines specialize in the detection of particulate and cosmetic defects in pharmaceutical products, such as ampoules, vials, syringes, and cartridges. Using high-resolution camera systems and AI-driven image analysis, the AIM 8000 series enhances inspection accuracy while minimizing false rejects.

With its modular design, the AIM 8000 series accommodates a variety of container sizes and formats, ranging from 1 ml to larger capacities, ensuring flexibility in handling different products like insulin vials, vaccines, and biologics in cartridges. The system offers a throughput of up to 600 containers per minute, integrating seamlessly into both continuous and batch production lines.

Designed for efficiency, these machines utilize intelligent pre-spinning functions to homogenize products and eliminate air bubbles, further optimizing the inspection process. The incorporation of PLC control facilitates seamless automation and integration with existing line setups, while maintaining energy efficiency with its optimized motor systems.

Constructed from high-grade stainless steel, the AIM 8000 series ensures durability and resistance to corrosion, meeting stringent GMP and FDA compliance standards essential for pharmaceutical applications. Additionally, it features a built-in re-inspection function and supports Container Closure Integrity (CCI) testing, solidifying its role as a critical component in maintaining product safety and quality.

Engineered for ease of use, the series supports quick changeovers and includes customizable features to meet specific production needs, backed by Syntegon’s engineering support for tailored solutions.

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Fills and Packages Nutraceutical Capsules and Granules

Syntegon’s Nutraceutical Granule and Capsule Filling System offers a comprehensive solution tailored for the needs of nutraceutical producers and pharmaceutical manufacturers. Designed to improve operational efficiency, this system precisely fills capsules and packages granules, ensuring accurate dosage and minimal waste. Integrating seamlessly into both batch and continuous operations, it supports various production scales. The system accommodates a wide array of applications from encapsulating omega-3 capsules and vitamin tablets to packaging protein powder sachets and probiotic gummies.

With automation at its core, the system is equipped with PLC controls for streamlined operations and offers remote monitoring for enhanced production oversight. The equipment is constructed with durable stainless steel options, ensuring compliance with GMP standards and reliability under extensive operational use. Maintenance is efficient with an integrated CIP system that allows thorough cleaning without manual intervention. Additionally, customization options are available to adapt filling and packaging capabilities to specific product requirements, providing engineering support to optimize your production line.

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Forms, Fills, and Seals with Paper Materials

The TPU Forming, Filling, and Sealing Machine from Syntegon offers a transformative approach to sustainable packaging through its innovative use of paper materials. This machine reduces plastic dependency by molding paper into 3D shapes, ideal for various sectors, including food, cosmetics, and electronics. It efficiently processes diverse end-products like chocolate bars, vitamin blister packs, and toothpaste tubes, meeting modern sustainability demands.

With a modular design, the TPU adapts to production needs ranging from small batches to medium-sized runs, ensuring seamless integration into existing production lines. It supports continuous and scalable operations, offering automation through its PLC-controlled systems, which allow for remote monitoring and adjustments.

The machine operates using a precise forming, filling, and sealing process, ensuring optimal product protection with or without barrier layers. The compact and energy-efficient design is engineered to meet environmental and operational objectives, using significantly less plastic than traditional means.

Manufacturers benefit from customization options, such as adaptable forming mechanics to suit specific packaging requirements and engineering support for tailored implementations. The TPU also complies with stringent industry standards, enhancing its appeal for forward-thinking companies aiming to enhance their sustainable packaging initiatives.

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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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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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Ensures Sterile Syringe Filling and Decontamination

The Aseptic Syringe Filling Isolator System from Telstar is engineered to enhance sterility in biopharmaceutical and pharmaceutical production, specifically designed for aseptic syringe filling. This system features a multi-chamber design that enables seamless integration into pilot-scale production lines, ensuring sterile conditions with ISO Class 4.8 (grade A) air cleanliness. Equipped with a recirculatory unidirectional airflow system and an independent decontamination chamber, it provides robust contamination control. Ideal for producing sterile injectables, pre-filled syringes, ophthalmic solutions, and pilot-scale sterile batches, it utilizes Integral Telstar ionHP+ bio-decontamination for high purification levels. With automated air temperature and humidity control, it maintains <3% RH, enhancing process consistency. RFID glove testing and viable/non-viable monitoring ensure compliance with stringent GMP standards. The system supports easy integration with existing equipment through its configurable design, facilitating efficient transitions and minimal downtime.

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