Bacterial endotoxins are a hidden-but-dangerous threat for medical devices that contact circulating blood, cerebrospinal fluid, or internal tissues. These pyrogenic substances—produced by Gram-negative bacteria—can trigger fever, inflammation, and even septic shock in patients.

Orthopedic OEMs are under growing pressure to move faster without compromising compliance. At OMTEC 2025, LSO will showcase how consolidating packaging, sterilization, and cleanroom assembly under one roof helps eliminate delays and accelerate commercialization. Visit us at Booth 350—or schedule time with our team whether you’re attending or not.

EtO residual testing ensures that your ethylene oxide sterilized medical device is safe for use and compliant with ISO 10993-7 and FDA requirements. Because patient safety and regulatory submissions depend on accurate chemical residue analysis, EtO residual testing should be a non-negotiable part of your sterilization validation strategy.

Bioburden testing should never be reduced to a set-it-and-forget-it calendar task. It is a living part of your quality system and a primary indicator of your microbial control status. While quarterly testing is a good starting point for many manufacturers, a truly risk-based program requires ongoing evaluation.

Sterilization is a critical step for injectable and combination products—but few providers are certified by FDA’s CDER to perform it. This blog explains what CDER certification means, why certified steam sterilization is rare, and how in-house capacity and technical expertise help OEMs avoid delays, ensure compliance, and streamline the path to market.

Find out if VHP sterilization is suitable for your medical devices and explore alternatives for optimal sterilization results.

Steam sterilization is a popular medical device sterilization method that many manufacturers use to successfully prepare their devices for market and meet industry regulation standards. But is it right for your device? Learn how it works, the ISO industry standards, which devices are ideal for this sterilization method, and how it compares to other sterilization options available on the market today.

Medical device companies: Have you experienced sterilization setbacks resulting from stricter EtO regulations and need a local provider? These regulations have increased turnaround times for products to be sterilized via EtO in recent years, causing various delays and loss of revenue for companies just like yours. Fortunately, there IS a solution to address these challenges! Read our new blog to learn more.