Shorten Process Validation Time & Satisfy FDA Standards
Build reliability into your production process from the ground-up.
We partner with medical device manufacturers to build successful quality management and validation processes for applications such as bonding, sealing, coating, printing, painting or cleaning.
Brighton Science supports manufacturers by:
- Scaling new processes and equipment to production
- Screening materials to ensure material system compatibility
- Reviewing conceptual adhesion processes and identification of Critical Control Points where adhesion issues may occur, starting with setting specifications for incoming materials
- Determining the required surface characteristics at each Critical Control Point by establishing the required cleanliness number
- Establishing pass/fail numbers at each Critical Control Point using the Surface Analyst
- Specifying the appropriate surface preparation process for the material system, i.e. plasma treatment, abrasion, etching, etc.
- Developing an Experimental Test Plan
- Analyzing bond strength of dissimilar materials
- Implementing commissioning and qualification
Complete the form to request a call with one of our Process Experts.