6 6.16.2Procedure General notesThe

6 6.1
6.2
Procedure General notes
The sterile barrier systems that are used for sterilized medical devices must fulfill requirements as defined in EN ISO11607.
The performance characteristics for materials, preformed sterile barrier systems and sterile barrier systems that are to be evaluated are described in EN ISO 11607-1. The requirements for the validation of packaging process are described in EN ISO 11607-2.
Process development
Process development or process design requires an assessment to identify and evaluate critical parameters, along with their operating ranges, settings and tolerances.
A process assessment is conducted to establish appropriate and necessary upper and lower processing limits, as well as the expected normal operating conditions. These process limits should be sufficiently removed from failure or marginal conditions. One technique could be the creation of seal-strength curves with accompanying visual examples of seal results that could aid in the selection of an optimal process window.
Potential failure modes and action levels having the greatest impact on the process should be identified and addressed (failure mode and effects analysis, cause and effect analysis). Statistically valid techniques, such as screening experiments and statistically designed experiments to optimize the process, should be used.
Essential processing parameters that are evaluated may include, but are not limited to:
 temperature;
 pressure/vacuum, including rate of change;
 dwell time (line speed);
 energy levels/frequency (radio frequency/ultrasonic);
 torque limits for lid/cap closure systems.
The selected essential parameters will be selected such that they will produce a process that is in control, and capable of yielding sterile barrier systems and packaging systems that meet predetermined design specifications.
Approved