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SP i-Dositecno SY Syringe Filling Equipment

SP i-Dositecno’s SY Syringe Filling equipment is a complete filling, stoppering and plunger insertion solution that promises sterility and accuracy, while adhering to the most stringent regulatory requirements. Simplify your manufacturing operations with innovative robotics. Our systems enable the rapid assembly of syringes or cartridges in sterile, clean, ready-to-fill (SCF) tubs – for the ultimate production protection.

  • Unparalleled accuracy –  Stäubli Robot de-nests and re-nests syringes or cartridges with precision
  • Cleanroom ready
  • Fully compliant – 21 CFR Part 11 software and IQ/OQ validation
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Overview

With growing demand for pharmaceutical manufacturing, never has it been more important to have access to dependable systems that insert plungers and label syringes and cartridges at speed, and without compromising accuracy. The SP i-Dositecno SY pharmaceutical filling and labeling machine is reliable, compact and GMP-compliant, so you can feel confident that no matter the demand, regulatory requirements or space restraints – we’ve got you covered.

SP i-Dositecno SY Labeler systems can fill up to 6,000 units per hour (uph) with features that include:
  • cGMP and Annex 1, 21 CFR Part 11 and GAMP5 compliance
  • Process ready-to-use (RTU) components: syringes, and cartridges – with respective change parts
  • Stäubli Stericlean robot meets the most stringent requirements for hydrogen peroxide decontamination
  • Equipped with indicator lights
  • Available with two filling nozzles for 0.1 mL to 20 mL

The SP i-Dositecno SY pharmaceutical labeling machine comes complete with Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the output rate and height for each vessel size. With help from our subject matter experts and dedicated engineers, you can configure the SP i-Dositecno SY pharmaceutical filling and labeling machine to meet your exact needs.

Features & Benefits

  • Easily integrated – the SP i-Dositecno SY Syringe Filling equipment slots easily into common isolators and can be integrated with our other filling systems
  • Speed to market – rapid and precise product assembly for faster delivery times
  • Versatile – many options to incorporate into the line such as 100% in process weight check (IPC), PEEK change part materials, nitrogen flush, idle wheel crimping with vertical force monitoring, and CIP/SIP
  • Ultimate product protection – can be integrated with open restricted access barrier systems (RABS), closed RABS, and isolation technology
  •  Project Management and optional validation assistance, Installation Qualification (IQ), and Operational Qualification (OQ) included as standard

Application Examples

  • Human Injectables Products
  • Diagnostic & Test Kits
  • Powder Fill