Hull i-Dositecno RF Flex-Line Robotic-Syringe Fillers
The Hull i-Dositecno RF Flex-Line™ is built on years of fill-finish expertise so you get the perfect partner for your production fill-finish workflow – helping you to market faster. Innovative Stäubli robotics enables the accurate and consistent transport and filling of syringes, cartridges, microvials and vials in sterile, clean, ready-to-fill (SCF) tubs – all while meeting the most stringent regulatory requirements.
- Fill up to 4,000 units per hour (uph)
- Cleanroom ready
- Fully compliant – 21 CFR Part 11 compliant integrated software and IQ/OQ validation packages available
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Overview
If you need a production fill-finish solution that offers the flexibility to fill components with differing container closure systems, you’ve come to the right place! Hull i-Dositecno RF Flex-Line adapts to your exact configuration and, being wall mountable, takes up minimal footprint while allowing you to easily access key components. Whether you’re filling microvials, pre-sterilized vials, syringes or cartridges, rest assured you’ll get sterility, accuracy and speed.
Application Examples
- Human Injectables Products
- Diagnostic & Test Kits
- Powder Fill
- Nasal Spray
Engineered using premium stainless steel to guarantee longevity, the Hull i-Dositecno RF Flex-Line systems feature:
⦁ Built to cGMP and compliant to Annex 1, 21 CFR Part 11 and GAMP5
⦁ Process ready-to-use (RTU) components: vials, syringes, cartridge, microvials with respective change parts
⦁ Aseptic dosing system using peristaltic, ceramic/stainless steel rotary piston pump, micro-dosing auger for exceptional accuracy and precision
⦁ Stäubli Stericlean robot meets the most stringent requirements for hydrogen peroxide decontamination
⦁ Turntable minimizes particulate caused by glass-to-glass contact between vials during tray or bulk filling
⦁ Servo-driven linear transport of containers and filling nozzles
⦁ Available with up to 2-channel pick and place for stoppers, tips and caps, and with up to two filling nozzles
The Hull i-Dositecno RF Flex-Line comes complete with Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the output rate, height and product/gas flow for each component size. With help from our product portfolio experts and dedicated engineers, you can configure the RF Flex-Line to meet your exact needs.
Additional Details
Features & Benefits
- Easily integrated for a full line solution – compatible with our vial washers, sterilization and depyrogenation tunnels, semi or automatic freeze dryer loading & unloading systems, lyophilizers, capping machines, and external vial washers
- Eliminate batch variability with 100% in process check weight (IPC), minimal reduction in processing speeds, for superior accuracy and repeatability throughout the entire batch
- Unrivalled accuracy – dedicated recipe and servo based pick and place system ensure the proper placement of stoppers and plungers
- Versatile – many options to incorporate into the line such as 100% IPC, PEEK change part materials, nitrogen flush, idle wheel crimping with vertical force monitoring, CIP/SIP
- Ultimate product protection – can be integrated with open restricted access barrier systems (RABS), closed RABS and isolation technology
- Superior product preservation and protection – gas flushing before, during and after filling
- ATS Scientific Products provides Project Management and optional validation assistance, Installation Qualification (IQ) and Operational Qualification (OQ)