12 months


Our client a major international Medical Device Manufacturer, headquartered in NJ, USA, with manufacturing locations in Belarus and Slovakia.


The project was to transfer sterilization processing of existing products manufactured in Slovakia and Belarus to a new Contract Sterilization Facility located in Belarus. This is the preferred option to the existing sterilization supplier in Slovakia (an EU Country) - this means most manufacture and all sterilization will all take place within the Russian Federation providing optimal flexibility for distribution of the product portfolio within the Russian Federation. This transfer necessitated full validation of 100% EO Sterilizers in accordance with ISO 11135 requirements. The project contained many risks and the complexity required tight management and control across several locations.


Reporting operationally to the Associate Director Quality Europe Region and communicating with senior company management across four different locations on progress and recommending technical, quality and regulatory strategy as necessary, including:

  • Ensuring that the EO sterilizers (n=2, 8 pallet chambers) used at the new contract sterilization facility in Belarus are fully validated for all products produced at the manufacturing facilities.
  • Development of Validation Protocols and associated reports for the performance of Operational Qualifications, Fractional Cycles, Half Cycles and Full Cycles in accordance with the overkill methodology given in ISO 11135. All protocols and reports must be translated into Russian which places particular focus on meeting document delivery timelines.
  • Development of design control procedures with the client R&D group to ensure that all devices can be systematically analyzed to identify the most difficult to sterilize candidates and the suitable design of IPCDs and EPCDs for use in Fractional and Half Cycle MPQ studies
  • The project is particularly complex and demanding as neither the Client or new Sterilization subcontractor are well resourced with sterilization expertise, Medicom was very much the main resource for all aspects of the project.
  • Provision of guidance and training in aseptic technique required for testing of IPCDs & EPCDs as previously mentioned there is no strong internal resource at the laboratory in this area.
  • To work closely with other parties to assist where requested in the implementation of a documented QS complying with ISO 13485.
  • Ensure that the final output of protocols and associated reports obtains certification by the designated Notified Body to allow sale of product in the EU.


  • The project is now deemed by the client to be fully successful as the newly validated sterilization facility has been successfully inspected and accepted by both CIS and EU regulatory authorities and has gone into full production service for the client company.
  • The client company now also wishes to retain Medicom for other services in sterilization, and general quality compliance.