Where Does Package Design Begin?
During the design phase, IVD manufacturers must consider a number of questions. Although not all of these may require equal attention, each should be addressed to help ensure design quality. Will the kits be marketed stateside, overseas, or both? It is important to keep in mind that package design may change from clinical trials to market introduction. Have active components been finalized? A manufacturer’s development group should have chosen the final dosage format—liquid, lyophilized, tablet, powder, bead, or a combination of these. Will a sterile fill be required? As more-specific package components are considered, an answer to this simple question will help determine the primary container and closure materials. What type of primary container and closure system will be used? Plastic and glass bottles remain the containers of choice for IVD manufacturers. But manufacturers must also consider the variety of screw caps and liners, stoppers, aluminum seals, syringes, and other componen
