Navigating how to produce a sterile product can be seen as a challenging process but let's break it down into steps for your consideration. Some of these items may be done in parallel (e.g. selection of sterilization provider along with packaging definitions). While the sterilization aspires to be perfect science, the process to develop the process for your product can be a trial and error if one doesn't have experience.
Here are the steps we propose:
1. Modality/Method Choice... What method can I use? - if you look at the product materials your device is made out of this often indicates the best method to use.
Many materials drive the sterilization method. For instance Steam and dry heat require materials that can withstand high temperatures. Some products degrade by certain processes such as UV light and Irradiation. Sometimes you can adjust parameters to make a certain material work such as temperature or actual amount of exposure. For traditional methods there is a lot of published data and ISO standards around that can help.
2. Packaging and its compatibility with sterilization method.
3. Labeling to ensure conformance during sterilization.
4. Contract Sterilizer selection, qualification, registration (FDA), commercial agreements.
5. Validation of the sterilization process to document effectivity and lethality.
6. Shelf Life claims determination (applicable to medical devices).
7.Regulatory submissions and approvals.
Do you agree with these? What's your favorite method and why? Leave a comment below. Your comments and thoughts in the section below will help us expand on more items that we can provide additional input.
If this all sounds too much or you have questions contact us and we will help you on your journey.