Sterile syringe plunger placement system
Ensure precision in syringe assembly with enhanced plunger placement, maintaining sterility and compliance in high-speed pharmaceutical operations.
Inserts Plunger Rods Precisely in Syringe Assembly
The Hull i-Dositecno Ready-to-Use (RTU) Rod Inserter is engineered for high-speed syringe assembly in the pharmaceutical, biotech, and life sciences sectors. This servo-driven equipment precisely inserts plunger rods into prefilled syringes, ensuring secure product assembly in sterile environments. Designed to meet stringent cGMP, Annex 1, and 21 CFR Part 11 standards, it supports a range of injectable products, from vaccines to monoclonal antibody syringes. Integrated seamlessly with the Hull i-Dositecno RF Flex-Line™, the rod inserter enhances throughput and maintains compliance with automated IQ/OQ validation. Constructed from premium stainless steel, it withstands corrosive sterilization agents, providing durability and reliability in demanding operations. The system’s servo-driven star wheel facilitates smooth syringe transition, optimizing your fill-finish workflow while reducing energy consumption during high-speed continuous operations.
Benefits
- Ensures precise syringe assembly, minimizing product defects and waste.
- Meets global compliance standards, facilitating regulatory approvals.
- Integrates smoothly into existing production lines, reducing setup time.
- Withstands harsh sterilization, prolonging equipment lifespan.
- Enhances operational efficiency with servo-driven, high-speed automation.
- Applications
- Human injectables products,Test kits,Diagnostic
- End products
- Insulin syringes,Vaccines,Immunoassay test strips,Pcr test kits,Epidural kits,Monoclonal antibody syringes
- Steps before
- Syringe Filling,Plunger Preparation
- Steps after
- Sterilization,Quality Control,Packaging
- Input ingredients
- syringe plunger,syringes,sterilization chemicals
- Output ingredients
- filled syringe products,secure syringe products
- Market info
- Compliance
- 21 CFR Part 11
- Material
- Premium stainless steel
- Automation
- Servo-driven star wheel
- Feeding Lines
- 1 or 2 feeding lines
- Compatibility
- Compatible with RF Flex-Line™
- Operational Environment
- High-sterile environments
- Syringe Transition
- Smooth transition
- Software
- Integrated with 21 CFR Part 11 software
- Validation
- IQ/OQ validation packages available
- Quality Standards
- cGMP,Annex 1,GAMP5
- Working mechanism
- Servo-driven star wheel
- Integrated steps
- Syringe fill-finish workflow
- Automation level
- PLCs
- Batch vs. continuous operation
- Inline Continuous
- Cleanroom operation compliance
- ISO 7 / ISO 8
- Sterile environment compatibility
- RABs / Isolation Chambers
- CIP/SIP
- Compatible with corrosive sterilization chemicals
- Corrosive resistance (e.g. acids)
- Yes
- Use case
- Human injectables,Diagnostic,Test Kits
- GMP Compliance
- cGMP,Annex 1
- Software Compliance
- 21 CFR Part 11
- Validation Packages
- IQ/OQ Validation
- Integration Capability
- RF Flex-Line™ Compatible
- Control panel type
- Integrated software
- Integration possibilities
- Hull i-Dositecno RF Flex-Line™
- Compliance,Integration
- 21 CFR Part 11 Compliant
- Material
- Premium Stainless Steel