Regulatory compliance meets technical precision

Cleaning medical devices is a complex task with critical consequences. You need to be sure that your components are completely free of oils, residues, bioburden, or particulates—without compromising the material itself. But with regulatory scrutiny only increasing, and materials growing more complex, it’s harder than ever to define a process that’s both compliant and effective.

Eurofins Sterile Packaging is a trusted partner for manufacturers who cannot afford to compromise. Our sterile packaging and cleaning services have been developed to meet the highest global standards, combining ISO Class 7 and 8 cleanroom facilities with decades of experience, advanced cleaning technologies, and rigorous in-house validation procedures.

We support you in defining the most appropriate cleaning method for your device, based on its material, application, and end-use. Whether your priority is bioburden reduction, particulate removal, or residue elimination, our experts ensure every process is effective, repeatable, and aligned to global regulatory requirements. With all cleaning performed under ISO Class 7 or Class 8 cleanroom conditions, we ensure your components are ready for the next stage of sterile packaging or assembly.

Extensive cleaning facilities Feature:

  •          Cleaning validation
  •          Vacuum extraction cleaning technology
  •          Cleaning and disinfection machines
  •          Vacuum drying
  •          Drying cabinets
  •          Drying with laminar flow
  •          Reverse osmosis system for water treatment
  •          Washing and disinfection machine, with and without detergent substances
  •          Rinsing bath with and without Isopropanol (IPA)
  •          Ultrasonic bath with and without IPA
  •          Wipe disinfection
  •          Plasma cleaning

We also offer in-house cleaning validation to demonstrate repeatability and compliance, helping to streamline your regulatory submissions and give you confidence in every cleaned component. Our experts work closely with your teams to identify suitable detergents and solvents, design custom cleaning protocols, and validate them against real-world scenarios. From early-stage development to full-scale production, we help you build sterility and compliance into every product, right from the start.