Fills and Stopper Nested Syringes and Vials

The Extrafill 10 by Marchesini Group is a high-speed, automated filling and stoppering machine specifically engineered for the pharmaceutical and biotech sectors. It excels in aseptic processing for liquid formulations, handling a range of container formats including nested syringes, vials, and cartridges. The machine employs a ten-head filling system with brushless motor-driven movements, ensuring precise dosing and reducing the risk of contamination thanks to its Balcony Style design, which promotes optimal airflow. Unique features such as the piston and peristaltic pump interchangeability, alongside in-process weight control, enhance operational flexibility. Capable of processing up to 36,000 syringes per hour, the Extrafill 10 integrates seamlessly into production lines with its denesting and detraying units, along with reject and recover systems for faulty containers. Compliance with GMP standards is ensured, with options for installation under LAF, RABS, or in isolator environments, offering a high degree of process control and contamination prevention. Additionally, the system facilitates efficient maintenance access and format changes, vital for minimizing downtime in high-demand environments.

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Fills, Decontaminates, and Seals Vials Aseptically

The integra Integrated Vial Filling and Isolator Technology System from groninger combines precise vial filling with the latest isolator technology for aseptic and toxic pharmaceutical applications. This system is engineered to enhance safety and efficiency, featuring SKANFOG decontamination for maintaining sterility. Designed for biopharmaceutical and biotech industries, it processes up to 400 vials per minute across a range of 2R to 100H vials, ideal for products like vaccines and monoclonal antibodies. The system’s automation and integration capabilities include servo motor adjustments, rapid changeovers, and stopper repositioning to minimize downtime and product loss. The integra’s compact design is compliant with GMP and allows full monitoring and control through advanced PLC systems, ensuring the highest standards in safety and operational efficiency. Available with options for stainless steel construction, the system also incorporates user-friendly elements like easy access for cleaning and maintenance through its ergonomic design. With comprehensive engineering support, groninger ensures that the integra adapts seamlessly into existing production lines for pharmaceutical manufacturers and CMOs.

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Fills and Closes RTU Vials, Cartridges, and Syringes

The flexpro 50 from groninger is an advanced aseptic filling machine tailored for the pharmaceutical and biotech sectors, excelling in filling and closing ready-to-use (RTU) vials, cartridges, and syringes. This system features the smartfill technology, incorporating 100% In-Process-Control (IPC) to minimize product loss and ensure precision during start-up and production. Ideal for applications in biopharmaceuticals, personalized medicines, and injectable therapies, it accommodates end-products like monoclonal antibodies, mRNA vaccines, and oncology drugs. Supporting high-speed, continuous operations, it seamlessly integrates into automated production lines and offers flexible format changeovers without tools, thanks to the quickconnect feature. Constructed for compliance with GMP standards, it assures sterile conditions via safetransfer methods, safeguarding the sterile introduction of components into the aseptic area. With scalable output and engineered customization, the flexpro 50 suits diverse production scales, from R&D labs to full-scale manufacturing.

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Fills and Seals Aseptic Vials, Syringes, and Cartridges

The flexfill from groninger is a modular aseptic filling machine designed to streamline the production of sterile liquid pharmaceuticals. Its unique modular design allows for rapid deployment and customization, meeting medium production volumes for pharmaceutical manufacturers and CDMOs. The system efficiently handles debagging, transfer, opening, filling, closing, denesting, and sealing processes for vials, syringes, and cartridges. Featuring flexible filling systems, including rotary piston and peristaltic pumps, it accommodates a variety of product viscosities and oxygen-sensitive formulations, with optional gassing and vacuum capabilities. Compliant with major regulatory standards, flexfill ensures high process reliability with automated clamping, cutting, and In-Process-Control (IPC) to maximize output. The hygienic design supports fast cleaning, integrating into existing lines with ease and leveraging groninger’s high-end capping technology for minimized particle generation during sealing. Available with advanced camera systems for precise quality control, it meets GMP standards, providing pharmaceutical and biopharmaceutical manufacturers with a reliable solution for aseptic filling.

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Assembles and Inspects Pharmaceutical Syringes and Containers

Groninger’s Syringe Assembly Machines offer an integrated solution for the precise assembly and inspection of pharmaceutical primary packaging, including syringes, vials, and cartridges. These machines excel in handling delicate processes such as plunger rod insertion, labeling, and safety device assembly, ensuring the integrity of prefilled syringes used for a range of medical applications, from insulin delivery to vaccination. Capable of processing up to 600 objects per minute, these machines boast a modular design that allows for easy line integration and expansion with features like backstop mounting and advanced inspection systems. Their electromotive mechanisms ensure minimal energy consumption while maintaining high precision assembly. Stainless steel construction provides durability and compliance with GMP and FDA standards. Cleaning is simplified with an integrated tray loading and buffering system, complemented by comprehensive engineering support for customization to meet specific production requirements.

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Fills and Assembles Aseptic RTU Containers

The flexfill from groninger is an advanced filling machine designed for precise handling of aseptic pharmaceutical products in ready-to-use (RTU) containers. It specializes in filling and closing pre-sterilized syringes, vials, and cartridges, making it ideal for pharmaceuticals such as pre-filled syringes and vial-based vaccines. Employing no-touch transfer (NTT) and E-Beam decontamination options, it ensures contamination-free transfer into aseptic environments. Handling capacities range from small pilot batches to high-speed industrial production, accommodating up to 1,000 containers per minute, all controlled via a PLC system for seamless integration into production lines. Meeting strict GMP compliance, flexfill optimizes throughput with features like smartfill technology for minimal product loss and robust energy efficiency. Stainless steel construction ensures chemical compatibility, and automated in-process control (IPC) assures precise filling accuracy, making it a reliable choice for complex biopharmaceutical manufacturing needs.

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Fills, Stops, and Seals Aseptic Liquid Pharmaceuticals

The Labworx Benchtop Filling Machine from Groninger offers semi-automatic precision for small batch pharmaceutical and biopharmaceutical production. Utilizing state-of-the-art filling, stoppering, and sealing modules, it ensures aseptic conditions for sterile liquid injectables, vaccines, and clinical trial doses. Compact and benchtop-friendly, its design allows seamless integration into laboratory environments and small production lines.

The Labworx system incorporates a choice of peristaltic or rotary piston pumps for precise volume control, accommodating a filling range from 0.1ml to 250ml. Its modular design supports various container types, including vials, pre-filled syringes, and cartridges, with an output of up to 10 containers per minute. The machine’s hygienic design, compliant with 21 CFR Part 11, ensures adherence to pharmaceutical manufacturing standards.

Automation features include an intuitive human-machine interface accessible via HTML5-enabled devices, allowing for remote operation and monitoring. The system supports in-process control with options for single-use components, enhancing sterility and reducing cross-contamination risks. Expedited delivery and quick-connect technology minimize downtime, further accelerating time-to-market for research or commercial applications.

Materials of construction, including stainless steel, offer robustness and chemical compatibility, while standard connections enhance process integration. Customization options are available to meet specific laboratory requirements, with full engineering support provided by Groninger.

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Automates Aseptic Filling and Closing

The Robocell from groninger is a state-of-the-art gloveless robotic system designed for aseptic filling and closing of ready-to-use (RTU) syringes, vials, and cartridges. What sets the robocell apart is its complete automation, eliminating human intervention and thereby enhancing contamination control. It operates through an integrated robotic technology system, making it suitable for filling complex products like biological drugs, ADCs, and ATMPs across small and medium batches. The system boasts high flexibility, capable of handling various packaging materials—from pre-sterilized to snap-on caps—while achieving reduced changeover times with minimal format parts. Compliance with EU GMP Annex 1 ensures it meets stringent pharmaceutical standards, while an incorporated PUPSIT facilitates integrity testing, even in the absence of glove ports. With capabilities for CIP, robust cleaning, and maintenance, the robocell integrates seamlessly into processing and packaging operations, supporting pharmaceutical and biotech industries with reliable, hygienic aseptic production solutions.

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Processes and Stoppers Vials for Liquid Formulations

The vial filling and stoppering machine from groninger offers a cutting-edge solution for pharmaceutical and biopharmaceutical production lines. This equipment encompasses an integrated process for washing, sterilizing, filling, and stoppering vials, ensuring seamless operations from start to finish. Designed for a diverse range of liquid formulations, including vaccines, insulin, and monoclonal antibodies, it supports production outputs between 50 and 600 units per minute, accommodating both small and large batch operations.

Engineered for sterile areas and clean rooms, the machine adheres to cGMP requirements, integrating easily into your existing production line. The system features a quickconnect format changeover for minimal downtime, allowing tool-free transitions between different vial formats. Groninger’s vial filling machine is designed with 100% In-Process-Control (IPC) to maximize precision, coupled with smartfill technology to minimize product loss and achieve optimal efficiency.

This automated line can incorporate additional processes like freeze drying and external vial cleaning, enabling aseptic processing even to OEB5 or BSL2 levels. The equipment incorporates advanced technology like PUPSIT, CIP/SIP options, and a single-use fill path to avoid cross-contamination. It further offers flexibility in sealing with various rubber stoppers and push-fit closure systems like RayDyLyo®.

Constructed for durability and reliability, the machine can be tailored with materials like stainless steel to meet specific corrosion resistance needs. With compliance to EU GMP standards, the groninger vial filling and stoppering machine stands as a robust and adaptable choice for high-speed, automated pharmaceutical production.

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Fills and Caps Liquid Products in Small Batches

The Flexcare 10 from Groninger is a versatile filling and capping machine tailored for consumer healthcare, pharmaceutical, diagnostic, and dietary supplement manufacturers. This compact system excels in processing small batches of liquid products like cough syrups, eye drop solutions, and vitamin supplements. With capabilities including pre- and post-gassing, filling, and screwing, the Flexcare 10 ensures precise weight control and reliable sealing of glass and plastic bottles. It supports a range of filling systems, accommodating rotary piston pumps or peristaltic pumps based on product needs. Operating at speeds up to 70 containers per minute, it handles volumes from 1 to 400 ml, while its tool-free format changeover minimizes downtime. The machine’s GMP-compliant design integrates seamlessly into production lines, offering laminar flow attachment for contaminant-free filling. Furthermore, the Flexcare 10 provides customization options to meet specific process requirements, backed by Groninger’s engineering support for optimal production efficiency.

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