Analyzes Carbon Dioxide in Sealed Containers

The FMS-Carbon Dioxide Headspace Analyzer by Lighthouse Instruments is a pivotal tool for ensuring container closure integrity in the pharmaceutical and biopharmaceutical sectors. This benchtop analyzer is designed for non-destructive analysis of headspace carbon dioxide within sealed parenteral containers, facilitating critical tests and inspections across various stages of product development. Utilizing a precise detection system, it measures carbon dioxide levels to monitor microbial growth, verify container closure, and perform in-process control during production. Suitable for a range of product types, including liquids and powders, it efficiently tests configurations such as syringes, vials, and bottles. The analyzer supports integration into both laboratory settings and automated production lines, equipped with 21 CFR Part 11 and Annex 11 compliant software for secure data management. The device accommodates different glass types and sizes, ensuring versatility and compliance with industry standards.

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Non-Destructively Analyzes Moisture and Pressure

The FMS-Moisture/Pressure Headspace Analyzer from Lighthouse Instruments stands out for its ability to non-destructively monitor moisture partial pressure and total pressure within sealed parenteral containers. This benchtop analyzer excels in applications such as vacuum leak detection and moisture determination for pharmaceuticals, biologics, and lyophilized products. It effectively bridges critical phases of the product life cycle, enhancing product quality and integrity. The analyzer features a measurement range from 0 to 25 torr moisture and up to 1 atm total pressure. Designed for integration in laboratory and processing departments, it accommodates various container types, including syringes, vials, and ampoules, in clear and amber configurations. The equipment supports 21 CFR Part 11 compliance, ensuring adherence to industry standards, and offers configurable options for different diameters, making it versatile for diverse use cases. Additionally, its PLC-controlled system enables seamless integration and operation within automated environments, while adhering to stringent compliance standards essential for pharmaceutical manufacturing.

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Measures Water Activity in Drug Products

The FMS-Water Activity Headspace Analyzer by Lighthouse Instruments is engineered to precisely measure the water activity in pharmaceutical substrates. Utilizing a headspace analysis method, it enables real-time moisture exchange assessments and vapor transmission studies, ensuring product integrity and stability. Essential for quality control in pharmaceuticals, it replaces traditional methods like Karl Fischer Titration with efficiency, particularly for sterile products, tablets, and lyophilized vials. Designed for versatility, it supports configurations ranging from ampoules to vials and caters to outer diameters between 10.5 to 52mm. The instrument is 21 CFR Part 11 compliant, integrating seamlessly into your laboratory workflows with automation capabilities, ensuring reliable and repeatable results. Constructed for bench-top operation, the analyzer’s material choices and compliance with industry standards make it a robust addition to any drug development or QC laboratory setting.

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Inspects Syringe Needles for Defects

The CUBE XRS 500 from WILCO AG is an X-ray-based inspection module designed for precise evaluation of syringe needle integrity in pharmaceutical manufacturing. This state-of-the-art equipment integrates high-resolution X-ray imaging with 360° sample rotation to detect defects such as bent needles and needle hooks. Catering to industries like pharmaceutical and biotech, it ensures the sterility and safety of pre-filled syringes used in applications like insulin and epinephrine auto-injectors. Operating at production speeds of up to 500 syringes per minute, the CUBE XRS 500 fits seamlessly into syringe production lines. Compliant with GMP guidelines, it supports data handling per 21 CFR part 11 and offers toolless format changeover, making it suitable for aseptic environments. The system’s ability to be integrated into WILCO’s Automated Visual Inspection (AVI) systems further enhances its versatility and ensures comprehensive quality control in sterile liquid pharmaceuticals production.

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Inspects Syringe Needle Geometry and Detects Defects

The CUBE XRS 500 from WILCO AG is an X-ray syringe needle inspection module designed to enhance precision in pharmaceutical production lines. This equipment ensures the integrity and specification compliance of needles in pre-filled syringes, crucial for safe usage in applications like insulin delivery and chemotherapy. It operates by rotating syringes 360 degrees during inspection, capturing high-resolution images analyzed by advanced vision systems to detect defects and assess needle geometry. Capable of integrating into existing syringe production lines and supporting high-speed operations of up to 500 units per minute, the CUBE XRS 500 meets GMP guidelines and 21 CFR part 11 compliance. Its toolless format changeover facilitates easy adaptation to various syringe sizes, making it ideal for sterile liquid pharmaceuticals and applications where sterility is paramount. Additionally, it is engineered for aseptic environments, featuring static optical paths and non-destructive testing methods, ensuring maintenance of product integrity and safety.

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Measures Headspace Gas Concentrations in Sterile Containers

The NEO HSX Series from WILCO AG offers advanced headspace analysis for sterile pharmaceutical containers, utilizing laser absorption spectroscopy to accurately measure oxygen and carbon dioxide levels non-destructively. Key for ensuring container closure integrity, it’s designed for use with vials, syringes, and ampoules in lab-scale operations. What sets the NEO HSX apart is its precision, achieving up to 50% lower standard deviation with its fourth-generation laser technology. The system supports both manual and robot-assisted inspections, offering flexibility in sample handling. Ideal for pharmaceutical manufacturers, it integrates seamlessly into R&D and quality control processes while ensuring compliance with ISO Class 7 environments and 21 CFR Part 11 standards. The intuitive MAVIS operation system with customizable widgets enhances user interaction, and the system features a guided suitability test to secure operator-independent results.

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Measures Gas Concentrations in Pharmaceutical Packaging

The NEO HSX series from WILCO AG is designed for precision headspace gas analysis in pharmaceutical packaging. Utilizing laser absorption spectroscopy, this equipment ensures non-destructive measurement of critical gases such as oxygen and carbon dioxide. It’s ideal for small and large volume parenterals, BFS cards, and IV bags, maintaining container closure integrity across various packaging solutions.

The NEO HSX DUO features dual laser heads for simultaneous O2 and CO2 detection, enhancing productivity and precision with up to 50% reduced standard deviation through fourth-generation laser technology. Operations are simplified with the user-friendly MAVIS system, guiding operators through processes with an intuitive interface and LED status indicators.

The NEO HSX series supports both manual and automated testing, allowing seamless integration into quality control laboratories. It aligns with GMP standards and is 21 CFR Part 11 compliant, ensuring regulatory adherence. The system’s modular nature allows customization, with exchangeable sample holders for flexibility in testing, and integrated process safety features like a position monitoring system. This makes it a versatile choice for pharmaceutical manufacturers, biotechnology companies, CDMOs, and quality control laboratories seeking accurate headspace analysis and integrity assurance in their production lines.

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Non-Destructively Analyzes and Tests Packaging Integrity

The NEO series by WILCO AG, encompassing the NEO HSX ONE, NEO HSX DUO, and NEO DPX, offers cutting-edge solutions for non-destructive headspace analysis and container closure integrity testing in the pharmaceutical and biotech industries. Utilizing advanced laser absorption spectroscopy, these systems precisely measure gas concentrations in sterile containers, including vials, syringes, and ampoules. Designed for applications from R&D to production, they ensure the integrity and compliance of small and large volume parenterals, pre-filled syringes, and more.

The NEO HSX series boasts industry-leading sensitivity with its 4th generation laser technology, providing up to 50% higher precision, ideal for thorough leak detection and ensuring product quality. The systems are automation-ready, featuring intuitive operation through the MAVIS interface and a customizable, operator-friendly design. The compact NEO DPX integrates pressure and vacuum decay methods, supporting versatile packaging types with deterministic testing compliant with USP1207 standards. Both series offer flexible configurations and seamless integration into existing production lines, supported by compliance with GMP, ISO Class 7 environments, and 21 CFR Part 11 regulations, ensuring robust quality assurance for pharmaceutical manufacturers.

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Measures Gas Concentrations and Ensures Packaging Integrity

The NEO HSX Series by WILCO AG offers a sophisticated solution for headspace analysis in pharmaceutical and biopharmaceutical applications. Utilizing cutting-edge laser absorption spectroscopy, these analyzers precisely measure oxygen and carbon dioxide concentrations in sterile pharmaceutical packaging such as vials, syringes, and ampoules. The NEO HSX DUO, featuring dual laser heads, allows simultaneous O2 and CO2 detection, enhancing processing accuracy.

This series is integral to ensuring container closure integrity across various products, from vaccines to monoclonal antibodies and BFS nasal sprays. With the ability to process multiple packaging types manually or with robotic support, the NEO HSX Series accommodates capacities for vials ranging from 1 to 100 ml and syringes from 0.5 to 10 ml.

Automated via the MAVIS operating system, these analyzers offer intuitive user interaction and high operator friendliness, with features like exchangeable holders and position monitoring for maximum flexibility and process safety. The system’s plug-and-play sample holders and customizable interface enhance adaptability and process reliability.

Certified to meet GMP and FDA standards, the NEO HSX Series is 21 CFR part 11 compliant and designed for use in ISO Class 7 environments. With built-in UPS to prevent data loss and the ability to integrate with MES and SCADA systems, this equipment sets a benchmark in efficiency and compliance for quality control in sterile pharmaceutical productions.

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Measures Gas Concentrations in Pharmaceutical Packaging

The NEO HSX series from WILCO AG offers a cutting-edge solution for non-destructive laser headspace analysis in pharmaceutical packaging. Utilizing advanced laser absorption spectroscopy, the system precisely measures gas concentrations such as oxygen and carbon dioxide in vials, syringes, and ampoules, ensuring package integrity for sterile injectables. This series includes the NEO HSX ONE and NEO HSX DUO, with the latter providing simultaneous dual-laser capability for enhanced measurement accuracy. Ideal for pharmaceutical manufacturers and R&D labs, the NEO HSX operates seamlessly on manual or automated lines, boosting efficiency with a 50% reduction in measurement deviation due to its fourth-generation laser technology. Featuring the intuitive MAVIS operation system, the platform supports robust, operator-independent testing with constant feedback via LED status bars. Its modular design allows easy integration into existing workflows, offering flexibility with interchangeable sample holders and compliance with 21 CFR Part 11 and ISO Class 7 environments. Additionally, the system ensures process continuity with an integrated UPS and offers seamless data connectivity via OPC UA server.

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