ATS Hull LyoStar 4.0 R&D/Process Development Freeze Dryer
ATS VirTis Ultra 50L & 35L Pilot-Production Freeze Dryers
ATS VirTis Genesis Pilot Freeze Dryer
ATS Hull LyoConstellation S10/S20/S30 Pilot Lyophilizers
ATS VirTis AdVantage Pro Freeze Dryer
ATS VirTis General Purpose Freeze Dryer (GPFD)
ATS VirTis Freezemobile
Research, Developments & Pilot Scale Freeze Dryers/Lyophilizers
Filling/Stoppering/Capping
ATS i-Dositecno Versa-Line Pharmaceutical Filling Equipment
ATS i-Dositecno Micro-Line Vial Filling Lines
ATS i-Dositecno SY Flex-Line Robotic-Syringe Fillers
ATS i-Dositecno RF Flex-Line Robotic-Syringe Fillers
ATS i-Dositecno SY Syringe Filling Equipment
ATS i-Dositecno Ophtha-Line™
ATS i-Dositecno Nasal Spray Filling Machine
ATS Hull BI I/L Filler
ATS i-Dositecno LI-C Linear Capping Machine
ATS i-Dositecno Pharmaceutical Labeling Machine
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
Overview
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
The SP i-Dositecno SY Flex-Line comes complete with Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the output rate, height and water/air flow for each vessel size. With help from our product specialists and dedicated engineers, you can configure the SY Flex-Line to meet your exact needs.
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
Application Examples
- Human Injectables Products
- Diagnostic & Test Kits
- Powder Fill
- Multi- or Mono-Dose Nasal Spray