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.

General


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

Technical Specifications


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

Operating Characteristics


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

Material Compatibility


Corrosive resistance (e.g. acids)
Yes

Product type Characteristics


Use case
Human injectables,Diagnostic,Test Kits


GMP Compliance
cGMP,Annex 1
Software Compliance
21 CFR Part 11
Validation Packages
IQ/OQ Validation

Physical Characteristics


Integration Capability
RF Flex-Line™ Compatible

Custom Options


Control panel type
Integrated software
Integration possibilities
Hull i-Dositecno RF Flex-Line™
Compliance,Integration
21 CFR Part 11 Compliant
Material
Premium Stainless Steel