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Life Science Outsourcing’s veteran team of experts shares cutting-edge resources, regulatory insights, and partner-ready solutions.
Technical Terms Glossary
Decoding the language of medical device manufacturing
Sterilization & Validation

Medical Device Ethylene Oxide Sterilization: Environmental and Technician Safety

Ethylene oxide sterilization (EtO) has been a reliable medical device sterilization practice for many years. How does it impact the environment and technicians?
Sterilization & Validation

The Right Challenge Device for Ethylene Oxide (EO) Sterilization Validation

Ethylene oxide (EtO) sterilization for gas-compatible medical devices is a much sought-after process for terminal sterilization and sterilization of reusable devices. For some devices, it is the only sterilization method that is effective and will not damage the device. But how is it tested and validated? Biological indicators along with external process challenge devices are a key part of the process.
Sterilization & Validation

Is Gamma Sterilization the Best Choice for Your Medical Device?

Gamma irradiation may be the best choice for your medical device sterilization. But how can you be sure when there are several other options available?
Sterilization & Validation

7 Industry Recommended Best Practices for Medical Device Sterilization: Infographic

It is ideal to understand industry best practices when preparing to sterilize your medical devices through an outside resource.
Sterilization & Validation

3 Often Overlooked Elements of Medical Device Sterilization

Medical device sterilization is one area where attention to detail matters. Product integrity and patient safety depend on effective sterilization and validation processes.
Sterilization & Validation

3 Benefits to Conducting Sterilization with a Turnkey Manufacturing Partner

Bringing a medical device to market is a complicated process. It requires a lot of coordination and planning, not to mention extreme precision and appropriate documentation.
Sterilization & Validation

4 Best Practices for Better Batch EO Sterilization

When it comes to bringing a new or updated medical device to market, most startups and established OEMs know that sterilization is an essential step in the process. But these same manufacturers may have questions about which sterilization process will best fit their needs. As medical device manufacturers look at EO sterilization solutions, here’s a rundown of four best practices to streamline the process and ensure an optimal outcome.
Sterilization & Validation

4 Keys to Effective Medical Device Sterilization

Sterilization is a definitive concept. A medical device is either sterile – meaning free from viable organisms – or it’s not. Yet within the medical device sterilization and validation process, and the larger manufacturing landscape, there are a number of approaches to ensure this process has been achieved safely and effectively.