DBT does not offer direct laboratory services but we do offer services directed at helping companies consider the impact of particulate and microbial levels associated with the product and the process associated with its manufacture.

Design elements include:

  • Assess design from the perspective of determining bioburden limits
  • Assess design from the user’s perspective in terms of product use
  • Evaluate cleaning on design considerations for devices intended for re-use

Process elements include:

  • Defining process limits related to design and use requirements
  • Developing validation protocols to assess process cleaning and disinfection
  • Characterizing particulate and environmental bioburden
  • Developing statistically-based environmental programs related to design and process requirements