How do I do it? Starting to think about sterilization.
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 is a visual from Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020
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.
Packaging must be compatible with the sterilization method. Similar to the device itself packaging must allow for the sterilant to get to the device. For gas and steam methods this means packaging must be porous. For some of the more novel methods it cannot be cellulose as well so this has to be designed into the process and fulfill the needs of the product to maintain the sterility. There are some special methods where the pouch can be able to let gas in and out and then be modified to enable the pouch to stop moisture entering during the time the product is stored; it will remain functional (shelf life).
3. Labeling to ensure conformance during sterilization.
Most product is labeled prior to sterilization to avoid mix-ups and robust post-sterilization processing. Product labeling will often change depending on the sterilization method used. This can cause a big cost if the sterilization method is changed as it can affect multiple parts of the packaging: the primary pouch, insert box and shipper.
4. Contract Sterilizer selection, qualification, registration (FDA), commercial agreements.
The selection of how the sterilization is going to be performed can get very complicated as not all suppliers offer all methods, equipment can have different performances and tolerances. Some locations may have chambers or process restrictions that may not fit the product or the volume needed to be processed - either too small or too big. Capacity at some sites may not even enable them to offer you sterilization. Companies may also consider building their own facility vs paying for contract services but this can be time consuming.
5. Validation of the sterilization process to document effectivity and lethality.
Even when a sterilization method has been chosen there are often multiple approaches to the validation of the sterility. Many inputs will drive this such as how controlled the bioburden is, how much flexibility you want in manufacturing. In addition, even the markets it gets sold into can have some impact. You should also be aware that the validation will need to be maintained throughout the life cycle of the product. Validation may be for non-medical applications as well. Generally the more well established the sterilization method the more detailed the validation approaches have been covered in standards and guidance.
6. Shelf Life claims determination (applicable to medical devices).
Sterilization may change the shelf life for the device and the packaging, this may also need to be revisited if parameters change or you have a test failure that causes the cycle parameters to need to be modified. It is worth taking this into consideration as specifications are set to enable future changes to have minimal impact. Some suppliers can share data they already have and this may reduce the amount of work required.
7.Regulatory submissions and approvals.
For some products (medical devices and Pharmaceuticals) additional regulatory approvals will be required. If a product is sold globally each of these approvals may require different work to be completed prior to the product being sold.
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.