Sterilization Engineering

For most medical products, achieving sterility is among the highest development priorities. Consequently, it should be natural to give this process serious attention and effort in the development cycle. Unfortunately, many project teams fall into one extreme or another: either ignoring challenges until confronted with failed tests late in development, or adopting conservative, rigid guidelines that increase cost and lead times while limiting innovation. However, more deliberate, proactive efforts generally reduce development costs and decrease time to market.

Develop Devices For Sterilization

At Neuma, we know the struggle of identifying and resolving the constraints of sterilization for new devices already balancing manifold requirements. We use our experiences of common sterilization methods coupled with an analytical approach to develop robust sterilization processes. Whether the product and process are at conceptualization, engineering development, validation, or established in the market, we can develop and implement solutions to improve quality, efficacy, and/or cost.

Our sterilization engineering skillsets include:

  • Device sterilization capability assessment
  • Product-specific sterilization method comparison & selection
  • Develop sterilization processes for:
    • All FDA Established Category A methods (dry heat, EO, steam, irradiation)
    • Several FDA Established Category B methods
    • Novel methods, if applicable
  • Sterilization process analyses, including
    • Dose uniformity calculations for all radiation sterilization processes
    • Gas diffusion & heat transfer analyses
    • Optimized exposure determinations for bioburden methodologies
    • Most Resistant Site determination
  • Material selection
  • Functional impact test: planning & execution
  • Primary and secondary packaging design
  • Container Closure Integrity:  Overall sterile barrier system definition through to test method selection & development
  • Validation planning
  • Root cause analysis (microbiological, chemical, & mechanical)