1. Responsibility of Organizational units
Organizational units liable for various phases of shelf life testing program should be integrated in the written procedure. The procedure must include a Finished Device Sampling Plan that deals with the purpose of collecting the samples, the number of completed devices to be collected, sampling frequency, criteria for selection of sample and lots to be sampled.
2. Determine individual shelf life of components
Determine the individual shelf life of components like raw materials, packaging evaluation plan and how do they affect the shelf life of the finished device. This plan must include gaining data from suppliers and recording data for current and future designs.
3. Tips to store shelf life samples
A detailed plan must be made for storage of shelf life samples, including storage conditions and the environmental conditions to be controlled, monitored and recorded. Accelerated Aging Parameters that include details on validation of the accelerated system must also be formed. All the results needs to be sustained by real-time testing of shelf life samples to verify the approximate shelf life data segregated from the accelerated tests.
4. Simulation of Shipping and Handling Stress
Simulation of Shipping and Handling Stresses Plan is vital for testing the shelf life of any medical device. This plan includes temperature extreme challenge, vibration tests, actual shipping and deliberately mishandling the device to determine the effect of odd circumstances.
5. Place the expiry date on raw materials
The written plan must contain all the follow up procedures that should e taken after determining the shelf life of a medical device. This procedure should also include placing of the expiration date on each raw material in store and on the finished device to help stock rotation. The results of the shelf life testing might reflect a requirement to set limits on the time the device is held in storage, redesign the device packaging or control the environmental conditions to reduce degradation.