Sterilization Validation/Microbiology Processes Consulting

Lumino Advisors has the expertise to perform sterilization validation studies using Ethylene Oxide, Gamma, or Steam as appropriate to support ANSI, AAMI and ISO 11135, 11137, and 17665 standards. In addition, we can review your microbiology processes to ensure regulatory compliance, including environmental monitoring and clean room evaluations; bioburden monitoring and trending programs; package shelf life evaluations; and on-site steam sterilizer validations.

With decades of experience, Lumino Advisors has the expertise to design regulatory- accepted sterilization validation studies using ethylene oxide, gamma or steam (moist heat) as appropriate to support ANSI, AAMI, and ISO 11135, 11137, and 17665 standards. We design and coordinate the execution of studies for validation of sterilization processes at your site (field validations) or at a contract sterilization facility. Our Microbiology, Chemistry and Toxicology laboratories are available to perform the testing associated with the studies including package integrity, stability, biocompatibility, bioburden and expiration dating.
Lumino Advisors can guide you through the sterilization process for the release of product from a single batch during research and development or for clinical trial product, or using the batch release approach as part of a full validation study.
The knowledgeable, experienced staff at Lumino Advisors are able to evaluate the impact of changes to manufacturing operations, product or packaging configurations, or sterilization process to your validated processes. We can also guide you through required documentation including creating a sound rationale or the design of cycles and testing needed to support the change.
Environmental control is a requirement of all Good Manufacturing Practices and monitoring, trending and ongoing evaluations are key to the maintaining control in your manufacturing operation or your microbiological laboratory. Lumino advisors can help meet the requirements of your quality system regulation of your operation or laboratory by helping you design and optimize your monitoring programs, and through clean room evaluations and sterilizer validations. We can assist you with the setting of action and alert limits for your product and area monitoring. Lumino Advisors expertise includes:

  • Environmental monitoring
  • Bioburden monitoring
  • Trending programs
  • Clean room evaluations
  • On-site ethylene oxide and steam sterilizer validation