SP i-Dositecno SY Flex-Line Robotic-Syringe Fillers
Our trusted fill-finish solutions are built with care to get your product to market - safely and quickly. The SP i-Dositecno SY Flex-Line™ streamlines your production fill-finish – no matter your space, budget or regulatory requirements - all while delivering the same great quality you’ve come to expect from SP.
- Fill up to 21,000 units per hour (uph)
- Cleanroom ready
- Fully compliant - 21 CFR Part 11 compliant integrated software and IQ/OQ validation packages available
Interested in Learning More?
Finding the right production fill-finish solution for your exact needs can be a time-consuming and fraught task. If you need the flexibility to fill products into vessels with differing container closure systems, this is the place to be! SP i-Dositecno SY Flex-Line™ slots into your space with minimal disruption thanks to a unique ability to be wall-mounted, enabling you to access key components while minimizing footprint. And with high-performance features such as Stäubli robotics, you can be sure you’ll get sterility, accuracy, quality, and speed, whether you’re filling microvials, pre-sterilized vials, syringes or cartridges.
Engineered using premium stainless steel to guarantee longevity, the SP i-Dositecno SY 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 robot to meet the most stringent requirements for hydrogen peroxide decontamination
- Available with pick and place for stoppers, tips and caps
- Available with two, five, six or ten filling nozzles
- Human Injectables Products
- Diagnostic & Test Kits
- Powder Fill
- Multi- or Mono-Dose Nasal Spray
Features & Benefits
- 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
- Project Management and optional validation assistance, Installation Qualification (IQ), and Operational Qualification (OQ) included as standard
- 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
- Provision of support to provide mechanical and handshake support for viable, and non-viable particle monitoring, optional monitoring system