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