Shorten Process Validation Time & Satisfy FDA Standards

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.