THE BASICS OF MEDICAL DEVICE PACKAGING

Material Considerations

Consider the approximate size and weight of the Medical Device Packaging Equipment, the sterilization method(s), and thus the proposed quantity of sterile barriers (single barrier or double barrier) when designing the SBS. Determining your requirements early will help reduce lead times typically associated with packaging design and may leave early feasibility studies.

Equipment Qualifications

IQ (Installation Qualification)

This testing provides documented evidence that the utilities, safety features, and ancillary systems utilized within the function of the equipment meet the user’s specified requirements.

OQ (Operation Qualification)

This testing provides documented evidence that the upper and lower limit sealing operating parameters of a touch of kit provide seals that meet predetermined acceptance criteria for a specific material combination. Engineering studies should be completed before the OQ to figure out these limits and acceptance criteria.

PQ (Performance Qualification)

Three runs leave the facility to gauge variability because of material lots, machine equilibrium, personnel changes, and day-to-day environment changes.