The SP 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
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! SP 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.
Engineered using premium stainless steel to guarantee longevity, the SP 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