Rtu debagging system for pharmaceutical sterile environments

Designed to streamline your fill-finish process, this system effortlessly debags sterile packaging, ensuring high-speed, hands-off operation in controlled environments to maintain product sterility and safety.

Debags and Transports Sterile Pharmaceutical Containers

The Hull i-Dositecno Ready-to-Use (RTU) Debagging Machine is a pivotal solution for pharmaceutical manufacturers and life sciences companies aiming to optimize sterile packaging workflows. This automated debagging system efficiently removes protective packaging from pre-sterilized syringes, vials, and cartridges in high-sterile environments, such as restricted access barrier systems (RABs) or isolation chambers.

What sets this machine apart is its seamless integration with existing fill-finish lines, enabling uninterrupted process flow. Featuring PLC-controlled servo motors from Siemens or Allen Bradley, it allows precise adjustments in processing rate and height for different vessel types, ensuring adaptability across various production setups.

Ideal for applications involving human injectables, diagnostic kits, and pharmaceutical components, this debagging machine operates at high speeds to maintain continuous throughput while reducing contamination risks. The equipment is constructed from premium stainless steel, ensuring durability and compliance with strict cGMP, Annex 1, 21 CFR Part 11, and GAMP5 standards.

Its automated robotic system eliminates the need for manual intervention, enhancing safety and sterility. The intuitive design enables quick integration and requires minimal maintenance, with engineered support available for bespoke adjustments to meet specific operational needs.

Benefits

  • Enhances sterility by eliminating manual intervention during unpacking.
  • Integrates smoothly into existing fill-finish lines to ensure continuous operation.
  • Meets GMP and regulatory standards for high-risk sterile environments, ensuring compliance.
  • Adapts to various container types with customizable settings, increasing production flexibility.
  • Minimizes contamination risks in pharmaceutical and life sciences applications.

General


Applications
Human injectables products,Test kits,Pharmaceutical components,Diagnostic
End products
Diagnostic reagent cartridges,Vaccine vials,Sterile pre-filled syringes,Covid-19 test kits,Insulin pen cartridges
Steps before
Sterilization,Pre-Sterilization Packaging,Component Double-Bagging
Steps after
Delidding,Filling,Capping,Final Packaging
Input ingredients
sterile ready-to-use syringes,sterile ready-to-use vials,sterile ready-to-use cartridges,pre-sterilized components,double-bagged components
Output ingredients
debagged syringes,debagged vials,debagged cartridges,debagged micro-vials,ready-to-fill SCF tubs
Market info

Technical Specifications


Automation
Automated robotics
Construction Material
Premium stainless steel
Software Compliance
21 CFR Part 11
Integration
Slots into existing fill-finish line
Control System
Siemens or Allen Bradley HMI/PLC-controlled
Operator Intervention
No intervention needed
Sterility Environment
High-sterile environments
Sterility Compliance
cGMP,Annex 1,21 CFR Part 11,GAMP5
Component Flexibility
Syringes,vials,cartridges,micro-vials

Operating Characteristics


Automation level
PLC-controlled
Batch vs. continuous operation
Batch
Integration capability
Ready-to-use
Slots into existing fill-finish line
Changeover time
Minimized with automated processes
Sterility maintenance
Hands-off operation
Sterile environment compatibility
RABs and isolation chambers
Cleaning method
Compatible with sterile environments (cleanroom compliant)

Material Compatibility


Corrosive resistance (e.g. acids)
Premium Stainless Steel

Physical Characteristics


Machine footprint
Compact
Material
Premium stainless steel
Integration capability
Fits existing fill-finish line
Automation
Automated robotics
Feed/Discharge Method
In-feed roller conveyor,automatic bag pusher
Control panel type
HMI or PLC-controlled

Custom Options


Control panel type
Siemens or Allen Bradley HMI or PLC
Automation level adjustment
Servo motor control for rate and height adjustment