Flex-Line™ Robotic Filler
Fast-track your market entry with our robust aseptic filling platform. The Flex-Line™ Robotic Filler provides full integration of Scientific Products filling and Comecer isolation technologies for a seamless process from order through Validation.
- Production output 15-200 units per minute (upm)
- Capable of multiple formats: RTU vials, syringes and cartridges
- Containment integration with RABs or Isolator
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Overview
The Flex-Line™ Robotic Filler slots into your space with minimal disruption and brings elevated degree of versatility with the ability to process a variety of containers with minimum changeover time and high adaptability to the manufacturing needs.
Stäubli robotics combine cleanliness, precision, and speed for maximum process reliability; Comecer Isolation Technology make sure you’ll get sterility, accuracy and quality, whether you’re filling microvials, pre-sterilized vials, syringes or cartridges.
Ability to treat potent products thanks to isolators conceived for pharmaceutical companies who require high-level protection when processing Active Pharmaceutical Ingredients (API).
Optional Product Conservation modes offered combine hardware and software solutions designed to minimize wastage of expensive materials. This system is particularly effective during the initial and final stages of production batches as they optimize material usage, enhance efficiency, and reduce costs, all while supporting environmental sustainability and high-quality production standards.
Engineered using premium stainless steel to guarantee long-lasting durability, the Flex-Line™ systems include:
- cGMP, Annex 1, 21 CFR Part 11 and GAMP5 compliance
- Process ready-to-use (RTU) components: vials, syringes and cartridges – with respective change parts
- Servo-driven robotic transport of containers and filling nozzles
- Stäubli Stericlean robotics to meet the most stringent requirements for Vaporized Hydrogen Peroxide (VPHP) decontamination.
- Pick and place for stoppers, tips and caps
- Two, five, six or ten filling nozzles
The Flex-Line™ Robotic Filler offers the remarkable advantage of being equipped with Siemens or Allen Bradley PLC-controlled servo motors. These motors empower you to effortlessly and precisely configure the output rate, height, and water/air flow for every vessel size, providing unparalleled convenience and efficiency.
Our team of product specialists and engineers is available to assist you in customizing the Flex-Line™ to perfectly match your specific requirements.
Application Examples
- General Injectables Products – Human/Animal
- Biologics /Biosimilars ADC, MAPS, Hormones
- Injectable Pharmaceuticals
- Cell Therapies, Gene therapies, and protein-based therapeutics
- Nutritional Formulations
- Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs)
- Advanced Therapy Medicinal Products (ATMPs)
- Lyophilized Products
- 503 Compounded Sterile Preparations
Additional Details
Features & Benefits
- The inherent configuration versatility of this system offers a wide array of options to run micro vials, vials, syringes, or cartridges at speeds from 15 to 200 PPM. The Flex Line Robotic Filler can connect with a variety of upstream modules to match the customer’s desired process for de-bagging and de-lidding RTU components. It can also seamlessly connect with downstream machinery for label and plunger insertion of syringes or freeze dryers, cappers, external vial washers and tray loaders for a wide range of pharmaceutical aseptic products.
- One single Project Management team can provide a turnkey solution for the complete line comprised of all ATS equipment from project design through FAT, SAT and Validation. A single source for the complete line simplifies the implementation process, saves costs, ensures consistency in quality, reliability and documentation.
- Ultimate product protection is achieved through seamless integration with full isolation technology, as well as the option to utilize open or closed Restricted Access Barrier Systems (RABS).
- In-process statistical and 100% weight control not only enhances your product quality but also offers cost savings, compliance assurance, data-driven improvements, and increased production efficiency, ultimately contributing to the success of your operations.
- Gas flushing at multiple stages of the filling process offers superior product preservation and protection. It addresses critical aspects such as shelf-life extension, contamination prevention, structural integrity, customization, and regulatory compliance.
- Plungers insertion into syringes or cartridges either mechanically or via vacuum, with trigger movements programmable and adjustable through the HMI. Vacuum insertion aids in removing oxygen from the container and enhances production speed. Made from stainless steel AISI-316 and autoclavable technical plastics.
- For industries where product quality and safety are of paramount importance, we offer an optional particle monitoring system that can be installed in critical areas to monitor viable and nonviable particles to ensure the quality of the process