NEWS

THE EVOLUTION OF i.v. ROBOTICS

Steriline Robotics: Delivering pharmaceutical industry standards into your aseptic unit

Robotic Syringe Filling Machine type RSFM

STERILINE will shortly supply an aseptic filling line for syringes to a manufacturer for injectable products.

Robotic Tray Loader type RTL

STERILINE has jointly developed with one of the worldwide largest pharmaceutical companies a robotic tray loading system.

Robotic Vial Filling Line under ISOLATOR type RFCM50

STERILINE has jointly developed with a German manufacturer of cytotoxic products a filling line under Isolator.

SMALL BATCH FILLING FOR STERILE APPLICATIONS

COMPACT WASHING-,DEPYROGENATING- and FILLING LINE

STERILINE GOES ROBOTICS

STERILINE is currently in the process to re-design certain machines in order to simplify their portfolio for aseptic applications.

The NEW Triple Filler

A Vial, Cartridge and Syringe Filler ALL-IN-ONE!

 

THE EVOLUTION OF i.v. ROBOTICS

Steriline Robotics: Delivering pharmaceutical industry standards into your aseptic unit

The Steriline Robotics branch is a startup born thanks to the collaboration between Steriline, Politecnico of Milan and professionals in the field of compounding pharmacy automation. This combination of skills and expertise allowed the development of a State of the Art Aseptic Compounding System, which is unique in the market.

It is an innovative machine that represents the evolution of i.v. robotics and automates all the phases of the medication compounding.

The System includes two machines: a Loading, unloading, and labeling station (CLU) and an Aseptic Compounding Unit (ACU). A transfer unit allows the transfer of materials from the CLU to the ACU.

This technology is equipped with two cooperative robotic arms and combines vision system and RFID identification.

The aseptic compounding System can handle the following medications: vials, infusion bags and bottles, syringes and elastomeric infusions.

Main features:

ISOLATOR TECHNOLOGY

  • Our technology can be installed in a class D environment
  • It guarantees maximum protection of operators
  • Gloves con be used to access the machine without compromising the ISO 5 environment

VHP STERILISATION

  • Sterilization of all incoming materials with Vaporized Hydrogen Peroxide
  • Sterilization of the compounding chamber whenever appropriate
  • Sterilization time has no impact on compounding time

CONTINUOUS MONITORING

  • Continuous particle counting in operation
  • Temperature and relative humidity
  • Airflow speed
  • Differential pressure between isolator and surrounding room
  • Leak testing

ADVANCED VISION SYSTEMS

  • Identification of all incoming materials
  • Monitoring of loading and unloading operations
  • Verification of needle inclination and injection points, to avoid spillage

RFID

  • Positive identification of every item al all critical steps
  • Positive identification during final check and labeling


The system process:

Steriline has over 25 years of experience in delivering automated aseptic compounding solutions for major pharmaceutical industry client worldwide, producing products to the highest standard of quality and reliability.

DIRECTIVE 2006/42/EC

  • Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 of machinery

EUDRALEX VOL.4

  • EU Guidelines to Good Manufacturing Practice, Annex 11: Computerized Systems

ISO 13485:2012

  • Medical devices – Quality management systems – Requirements for regulatory purposes

IEC 62366-1:2015

  • Medical devices – part 1: Application of usability engineering to medical devices

IEC 62304:2006

  • Medical Device Software – Software life cycle processes

ISPE 2008-GAMP 5

  • GAMP 5: A risk-based approach to compliant GMP computerized systems

FDA GUIDANCE DOCUMENTS

  • Design control guidance for medical device manufacturers
  • Class II special controls guidance document: Pharmacy compounding systems
  • Applying human factors and usability engineering to medical devices
  • General principles of software validation
  • Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
  • Mobile medical Applications

eCFR

  • Electronic Code of Federal Regulations, Title 21, Part 820 Quality system regulation and part 11 Electronic Records; Electronic Signatures


     

 
 

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