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i-Dositecno Ready-to-Use (RTU) Debagging Machine

Unpack with ease! Rapidly remove protective packaging from sterile, ready-to-use syringes, vials, and cartridges. The i-Dositecno Ready-to-Use Debagging Equipment is ideal for use in high-sterile environments including restricted access barrier systems (RABs) and isolation chambers.

  • Built to comply with cleanroom requirements – engineered from premium stainless steel
  • Fully compliant – 21 CFR Part 11 integrated software and IQ/OQ validation packages available
  • Easily integrated – ready-to-use and slots into your existing fill-finish line

Overview

For a debagging system that meets all of your needs and offers the quality of a trusted global fill-finish manufacturer, the SP i-Dositecno Debagging Machine is here to help. Simplify your manufacturing workflow no matter the vessel type as the SP i-Dositecno Debagging Machine offers the ultimate flexibility, with automated robotics for the debagging of syringes, cartridges, micro-vials and vials in sterile ready-to-fill (SCF) tubs.

At SP, we understand that safety is paramount, that’s why our debagging machine does not require operator intervention; just push a button, activate the bag cutting and stand back as the sliding door opens to transport the tub to the delidding station. Pre-sterilized components are double-bagged. External packaging must be removed before entering the debagging equipment. Meeting the highest quality expectations of cGMP, Annex 1, 21 CFR Part 11 and GAMP5, our debagging equipment is engineered using premium steel for sterility and durability that you can rely on.

Our Ready-to-Use (RTU) Debagging Machine includes Siemens or Allen Bradley HMI or 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 Debagging Machine to meet your exact needs.

Application Examples

  • Human Injectables Products
  • Diagnostic & Test Kits
  • Powder Fill
  • UniDose or BiDose Nasal Spray

Features & Benefits

  • Designed for the ultimate sterility – the SP i-Dositecno Debagging Equipment can be assembled in an isolator or open and closed restricted access barrier systems (RABs)
  • Versatility is key! Process ready-to-use (RTU) components: vials, syringes, cartridge and micro-vials with ease using respective change parts
  • Hands off for unrivalled sterility: in-feed roller conveyor automatically transports sterile tubs to containment area, while the automatic bag pusher removes the tub from the bag and transfers to delidding station
  • Fully compliant – designed for high-risk sterile environments GMP Grade A/ISO 5
  • Integrated with ease – for a complete fill-finish solution