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.

Krista Precourt has been promoted to Chief Operating Officer at Life Science Outsourcing. Since joining in 2022, Krista has led key improvements across operations, strengthening LSO’s ability to deliver consistent quality, scalability, and responsiveness for MedTech clients. Her leadership reinforces LSO’s commitment to expertise-driven manufacturing and client success.

Medical device packaging doesn’t just need to pass sterility and shelf-life validation—it must also survive the rigors of distribution. Transportation testing is critical for proving that your packaging can protect devices from real-world hazards like vibration, drops, compression, and temperature fluctuations. We’ll break down the standard tests used to evaluate packaging performance during transportation, and how they help ensure regulatory compliance.