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i-Dositecno Ready-To-Use (RTU) Denesting Equipment

When it comes to your fill-finish workflow, sterility and efficiency are key. Denest and renest with confidence! Our ready-to-use (RTU) denesting equipment is here to help you separate and reassemble your products with ease. Rest assured the i-Dositecno Denesting Equipment is robust and efficient, so your sterile, clean, ready to fill (SCF) components are transported smoothly through your fill-finish workflow.

  • Cleanroom ready – engineered from premium steel to comply with cleanroom requirements
  • Fully compliant – 21 CFR Part 1 integrated software and IQ/OQ validation packages available

Overview

When your products are supplied in nested packaging and filled in pre-sterilized containers, you need a denesting and renesting system that offers accuracy, sterility and speed. The SP i-Dositecno Denesting Equipment includes innovative features such as a Stäubli TX2 robot with CS9 controller to ensure your SCF components are unloaded and reloaded with precision – whether that be syringes, vials or cartridges. And, with the capacity to process up to 2,400 units per hour (uph), there’s a solution for all of your needs.

Built to cGMP and compliant to Annex 1, 21CFR part 11 and GAMP5, our semi-automatic denesting equipment can be assembled in an isolator or restricted access barrier system (RABs) for the ultimate in aseptic processing. And if a full fill-finish line is what you need, the SP i-Dositecno Denesting Equipment is ready-to-use and easily integrated.

SP i-Dositecno’s Denesting Equipment includes Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the rate and height for each vessel. With help from our product portfolio experts and dedicated engineers, you can configure the SP i-Dositecno Denesting/Renesting Equipment to meet your exact needs.

Application Examples

  • Human Injectables Products
  • Diagnostic & Test Kits
  • Intraocular Injectible Products
  • Syringes, Cartridges, Vials

Features & Benefits

  • No room for human error! Minimal operator intervention required to move containers from one station to the next
  • Fully compliant – designed for high-risk sterile environments GMP Grade A/ISO 5
  • Resilient – enclosed arm structure and sealed vertical cable means the SP i-Dositecno Denesting Equipment is built to withstand the hydrogen peroxide (H2O2) decontamination process, with full resistance to vaporous and fluid H2O2
  • Compact and versatile – modular and scalable system with small footprint, thanks to integration of motors, enables easy integration into your existing line
  • SP provides project management and optional validation assistance, Installation Qualification (IQ) and Operational Qualification (OQ)
  • Semi-automatic with servo driven robotic transport of containers