Validating Medical Heat Sealers: Process Control that Goes Beyond Time, Temperature, and Pressure

comply with regulatory oversight and to be confident in the overall quality of the final product. Though there is some ambiguity in the industry as to the exact definition of validation, it is clear that all components of the sealing process that influence package integrity must be monitored, measured, and controlled. Moreover, equipment must perform the heat sealing function in a repeatable, invariable manner such that final product quality is consistent with predetermined standards. Typically, process control validation for heat sealing has dealt with three specific variables: dwell time, temperature, and sealing pressure. This white paper reviews the relevant regulatory standard for medical heat sealing and discusses some of the important considerations that should go into implementing an effective validation process. After covering some of the design characteristics that ought to be prioritized when considering the abovementioned process variables, it goes on to make the case that process validation for medical heat sealing needs to include a broader range of parameters – including seal-area wrinkles, band breaks, and label applications – beyond the traditional three of time, temperature, and sealing pressure. Ultimately, for a piece of heat sealing equipment to be fully validated, total process control should encompass every step that affects the quality of the final product. 1 | White Paper | Validating Medical Heat Sealers