Biopharmaceutical Engineering

Since its innovative origins, Grifols has continued to develop its own biopharmaceutical projects to solve its manufacturing needs, always adhering to the highest levels of quality and safety.

Project Management

Grifols Engineering, which  earned its internationally renowned reputation after years of hands-on experience developing Grifols’ industry-leading manufacturing capabilities  now provides the same service excellence to others in the biopharmaceutical sector.

  • Modular designs reduce the time to validation and start-up
  • Flexible designs that adapt to existing facilities
  • Automated processes with efficient and practical plans

We offer two project management models:

  • Integral turnkey project management for the biotech industry or sterile liquid manufacturing
  • Project management in stages:
    • Conceptual design
    • Basic engineering
    • Detailed engineering
    • Implementation and startup

Biotech Processes

Our experience in our plasma derivatives manufacturing plants enables us to work on both upstream and downstream processes.

UPSTREAM

  • Fermenters
  • Media and buffer tanks
  • Harvest tanks

These systems can be fully automated, minimizing running costs. The systems incorporate automated cleaning and sterilization processes, which can be validated.

 

DOWNSTREAM

  • Tangential filtration units:
    • Fully automated systems
    • Integrated system cleaning process
    • Configured to client requirements
    • Monitoring and recording of system control parameters
  • Chromatography columns:
    • Fully automated systems
    • Automatic elimination of air bubbles
    • Configured to client needs
    • Detects chromatography peaks
  • Viral inactivation:
    • Thermal
    • Chemical
    • Filtration
  • Machines for aseptic dosing of liquids GSF® (Grifols Sterile Filling):
    • Unique patented system for dosing liquid products under aseptic conditions
    • Global solutions: preparation and sterilization of components, handling, aseptic filling, process control and laser etching
    • More than 20 years of reliable aseptic dosing

General Processes

We specialize in the design of general processes for the pharmaceutical industry:

  • IV solutions:
    • Installation design and construction
    • Comprehensive turnkey project management
    • Technical support and documentation for the facility and product approval procedures
    • Re-engineering and automation of pending processes
  • Clean in place (CIP) and sterilization in place (SIP) units:
    • Innovative designs: with single tank and a single pump
    • Combined CIP: reactor and production line cleaning
    • Configured for any needs
    • Programmable logic controllers (PLCs) and touchscreen controls
    • Conforms to ASME-BPE 2002
  • Modular Cleanrooms: Misterium® (Mini Sterile Room)
    • Configurable modular cleanroom system
    • Multiple applications in the biopharmaceutical industry: processes requiring isolated, controlled and easy-to-clean environments, in-process microbial controls, pilot plants etc. 
  • Pharmaceutical Quality Water:
    • Systems to produce water for injection (WFI), purified water (PW) and highly purified water (HPW)
    • Compatible with water from wells or water systems
    • Water distribution loops at 4ºC, ambient temperature or 80ºC
    • In-house design of SCADA for system control
    • Innovative, easy-to-clean, U.S. FDA -approved designs

¿How can we help you?

For general, commercial, and technical inquiries, please contact the Grifols Engineering team directly.

Experience you can count on