Medical device sterilization is one area where attention to detail matters. Product integrity and patient safety depend on effective sterilization and validation processes. Yet even in this technical and detailed aspect of bringing a safe and effective product to market, key parts of the process are often overlooked or considered too late in the process. These missteps can lead to inefficiencies and delays in a product’s path to market. Worse, they can create issues with sterility or product safety.
In some cases, the overlooked aspects are driven by past experience. Organizations and individuals know what sterilization methods and processes they’ve used in the past. They look to replicate past success with current efforts.
Yet effective sterilization methods can vary greatly depending on the product, packaging, and intended use. Simply assuming past sterilization approaches will apply to current efforts can lead to inefficient and ineffective outcomes. Here are three aspects of medical device sterilization and validation that are too often overlooked – and what should be done instead.
1. Consider all device components
When considering which sterilization method to pursue, it’s important to consider the material composition of the device and all parts that go into the finished product. Certain sterilization techniques will impact materials differently.
Gamma sterilization, for instance, can change the colors of certain plastics. The high temperatures of steam sterilization melts some materials. Ethylene Oxide gas (EtO/EO) sterilization can absorb gas, which can impact residual testing. What’s more, complex products with long lumens or intricate pathways can also be challenging to sterilize with gas.
Thinking about sterilization requirements and methods early in the broader development and manufacturing process can help ensure there aren’t any unexpected surprises when it comes time to sterilize and validate. It’s worth considering how device designs and manufacturing will impact sterilization efforts down the road.
2. Consider package design
Package design and testing is another area that benefits from close collaboration with sterilization efforts. Medical device package sterilization will vary depending on the materials being used. Steam and gas sterilization methods will only be effective with packaging that porous enough to allow the vapor to penetrate. EO gas, for instance, can penetrate Tyvek.
Here again, it’s beneficial to consider package design and its impact on sterilization as early in the process as possible. Tests and trials are an effective way to evaluate how product design, packaging, and sterilization strategies align before changes or corrections become too costly.
3. Consider the full time needed for validation
In addition to specific concerns around the type of sterilization needed, some organizations fail to consider the full time needed for sterilization – and validation. Sterilizing a device is one thing. Demonstrating proof of sterility is something else entirely.
Typically, the full validation process can take 10 to 12 weeks, though that can often be expedited when needed. Existing backlogs, particularly with EO sterilization, can also lead to longer lead times and delays in the sterilization process. Accounting for that timing and incorporating it into product timelines is an essential step in sterilization planning that should not be overlooked.
A sterilization partner can help navigate trouble spots
Bringing an innovative new medical device to market is a complex process. It pays to rely on partners with experience and a proven track record to help navigate the many considerations, regulatory requirements, and tricky timelines – especially when it comes to sterilization and validation. Life Science Outsourcing has worked with countless clients to provide effective sterilization and validation efforts that ensure products are safe and development timelines are met.
