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Gloved technician drawing liquid from sterile vial into syringe in cleanroom environment
Sterilization & Validation

Few and Far Between: Why CDER-Certified Steam Sterilization—and the Experts Behind It—Matter for Combination Product OEMs

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.
Company News

Krista Precourt Named COO of Life Science Outsourcing: Strengthening Our Commitment to Clients

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.
LSO Medical Package Testing
Medical Package Testing

What Are the Standard Tests for Evaluating Packaging During Transportation?

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.

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