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. Which means it can be difficult to understand industry best practices when preparing to sterilize your medical devices through an external resource.

One thing is clear: better sterilization processes can help accelerate product development and manufacturing timelines while reducing costs and complexities for manufacturers and their partners. But the benefits of better approaches to sterilization don’t stop at the bottom line.

Each year, about 1 in 25 U.S. hospital patients is diagnosed with at least one infection related to hospital care alone; additional infections occur in other healthcare settings, according to the Centers for Disease Control. Sterilization is a vital line of defense against infections and a key step in minimizing risk to healthcare staff. It preserves value and reduces healthcare spending costs by ensuring the quality of new items and maintaining the value of reprocessed items. Effective decontamination is a means to a safer, more efficient healthcare system and a higher quality experience for patients and practitioners.

Given those goals, here’s a closer look at four things manufacturers should keep in mind to ensure a comprehensive and cost-effective sterilization process.

1. Sterilization considerations begin with product design …

Every decision made at each step of the product development process impacts the broader manufacturing process – sterilization being no exception. With that in mind, cleaning and decontamination considerations for a medical device must be taken into account during the product design phase. More complex designs and assembly requirements can create more complicated sterilization protocols down the road.

It’s just one reason why it’s important to think ahead and gather input from a team representing the entire product development life cycle – including healthcare professionals and end users.

2. … and extend to product delivery and use

A critical focus on sterilization’s place in the broader development timeline and product life cycle should continue until the device reaches its final destination and intended use. That includes storage and transportation. Minimizing exposure to moisture, humidity, dust, and other external environmental elements should be a top priority. In transit, handling and external conditions can also impact a device’s status.

3. Effective cleaning is essential to effective sterilization

During the sterilization phase, it pays to eliminate as much of the bioburden as possible. This can be accomplished through thorough and effective cleaning. Cleaning is the first and most important step in the decontamination process. It involves the removal – usually with a detergent and water – of both visible and non-visible soil (such as blood, protein substances, and other debris) from the surface of the medical device.

4. Documentation matters as much as processes

Sterilization is a vital element of medical device manufacturing – but so is validation and documentation. Unless it satisfies the reporting requirements of all regulators and related organizations, the sterilization process falls short of its intended goal. Records must be maintained in accordance with the health care organization’s requirements, along with local, state, and federal regulations and the details required by specific ISO standards and other guiding bodies, including:

  • ISO13485:2003 – Requirements for Quality Management System of Medical Device companies
  • ISO 25424:2009 – Low temperature steam and formaldehyde method
  • ISO 11135-1:2007 – Ethylene Oxide method
  • ISO 17665-1:2006 – Moist Heat/Steam method
  • ISO 15882:2008 – Guidance on Chemical indicators
  • ISO 11137-1:2006 – Radiation/Gamma Ray method

The Benefits of a Turnkey Sterilization Partner

These best practices underscore the value of considering sterilization as part of the broader medical device manufacturing process, while also ensuring the specific sterilization process and documentation is completed with high attention to detail. Understanding how different parts of the development and manufacturing processes impact each other is essential to reducing costs and inefficiencies while accelerating time to market.

Life Science Outsourcing has purposefully developed its services to help device manufacturers see around corners and anticipate how decisions at every step in the process can impact the development timeline. We work in close partnership with clients to navigate regulatory hurdles and other needs to ensure effective and efficient processes, including sterilization and validation.


To learn more about our Sterilization & Validation services, be sure to contact a member of our team today.