Isthmus has provided dozens of custom automation solutions to customers in the medical/life sciences industries. Detailed project planning, innovative concepts and high-tech machine designs are needed to provide manufacturers with a competitive edge in this growing field. Stringent industry and regulatory demands must also be accounted for. Isthmus incorporates the following principles of solid management and design basics into successful projects to best serve this demanding industry.

Project Management Experience

A thoughtful and consistent method to Project Management is critical for projects in the medical/life sciences industries. Ours was developed by certified Project Management Professionals (PMPs), and is based on Project Management Body of Knowledge (PMBOK^®) global standards.

Validation

Each project requires a customized approach to Validation, which we work carefully with the customer and project team to identify and finalize. Our guidelines have been developed based on the GAMP5 Guide for Validation of Automated Systems.

Ease of Cleaning/Material Selection

We understand that production medical device equipment must be built with considerations for cleaning and sanitizing in mind. In addition to careful selection of material finishes and passivation, machined parts for these projects have custom tool profiling and high polishes to ensure ease-of-clean.

Clean Room Experience

Many products in the Medical/Life Sciences Industries require processing in clean room rated facilities. Isthmus has experience providing systems for Class 100 (ISO 5) Clean Rooms, as well as providing systems with other unique processing requirements such as HEPA filtration systems, extreme high/low humidity requirements and handling of caustic fume extraction.