Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection method.Advanced approaches for quality assurance of these leading-edge treatments may be needed for a variety of reasons.
VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. Vacuum decay technology is also referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing.
The criteria for selecting the appropriate VeriPac model is based on the type of package and leak test sensitivity desired. Configurations can be optimized with either single or dual high-resolution transducers as well as type of vacuum supply, i.e. internal, external, high vacuum, etc.