Ensuring Sterilization Compliance: The Role of Single-Use Materials

Credit: J. J. Keller
Single-use materials have become extremely popular in industries that ordinarily require employees to follow reprocessing steps for sterilization and safety. What are some of the main reasons decision-makers have switched to them, and what are the potential downsides you should consider?
Shifting the Sterilization Burden
Hospitals and other facilities that handle used medical devices must follow specific procedures to prepare them for more patients. In addition to the purchases of specialized equipment, decision-makers must train their staff and remain continually vigilant for individual errors or process shortcomings that could cause contamination.
Some affected parties may decide products made from single-use materials make more sense for their budgets and operational needs. Then, users can dispose of the products rather than send them for reprocessing and rely on the machines and trained employees to do the next steps. This situation requires the manufacturers of single-use products to bear the responsibility of ensuring sterility.
Succeeding requires those producers to recognize contaminants coming from two primary sources. Intrinsic particles come from packaging materials or the assembly or formulation stages, while the manufacturing environment or humans generate those in the other category — extrinsic particles.
However, measuring particulate contamination in production settings can be challenging, especially because of the lack of standardization during visual inspection methods. Concerned parties should strongly consider only working with reputable suppliers that uphold manufacturing best practices and have well-established commitments to safety.
Shortcomings in production have far-reaching implications for the facilities using those products and the associated patients. Choosing reputable suppliers can reduce those issues and increase buyer confidence.
Increasing Productivity and Flexibility
Products made from single-use materials can raise productivity by reducing the need to sterilize the items after use. They also assist manufacturers by providing more flexibility and minimizing time-consuming steps. Parties working in high-demand facilities such as pharmaceutical plants will get more done when it takes them less time to adapt to changing needs.
Specialized equipment often contains both stainless steel and disposable components, elevating application breadth and scalability potential by reducing the parts people must clean between uses. Single-use technologies allow them to install or dispose of them as necessary, preventing downtime that would otherwise occur due to cleaning procedures. Additionally, these options support modularity, allowing leaders to adjust production flows as market needs dictate.
Since machine operators remove and replace single-use items between each batch, this approach eliminates contamination risks caused by reprocessing errors. Additionally, because the equipment required to sterilize reusable equipment occupies a significant footprint, opting for single-use goods can give producers more flexibility in other ways. For instance, they could consider expanding the output for an urgently needed vaccine or an especially widely prescribed and lucrative medication.
For example, many industry decision-makers rely on single-use chromatography systems. These alternatives let them devote more time to simultaneous projects rather than spending so much time on sterilization.
Enabling More Sustainable Choices
Wastefulness is a frequently discussed downside of single-use products. Many find it difficult to justify discarding something when they could sterilize and reuse it instead, but the trade-off is not always so clear cut. Throwing away single-use items is arguably not ideal when the world has a massive and growing waste problem. However, reprocessing also requires resources, most notably due to energy use during sterilization.
Even so, increased awareness of sustainability has caused many experts to prioritize forward-thinking options. For example, researchers, engineers and others have explored the use of plant-based plastics, including those that will naturally break down rather than accumulate in landfills. Alternatively, selecting single-use materials such as recycled plastics keeps products and resources in supply chains, unlocking opportunities to strengthen the circular economy.
Sometimes, recycling can occur directly on the premises of facilities that need single-use products, shortening the time frame for making their materials usable once again. One example is a machine that uses a proprietary biodegradable material to convert single-use plastics and other medical waste into recyclable polymer flakes that people can safely transport for further processing.
One health system’s core laboratory plans to process more than 500,000 pounds of annual waste this way as part of an overarching goal to recycle 25% of its total waste volume by 2027. This on-site method allows users to handle waste responsibly without increasing transportation emissions.
Balancing Sterilization with Competing Needs
As decision-makers weigh whether single-use materials are most appropriate for their needs, they must consider sterilization compliance alongside other priorities and evaluate the pros and cons. Additionally, how often organizations use specific products may influence whether staff should reprocess them for reuse or opt for single-use alternatives. Since there is no universally applicable answer for every facility, leaders must make thoughtful choices while understanding the relevant usage behaviors.
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