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.

Medical device companies looking for a contract ethylene oxide sterilization partner must be aware of the latest regulations surrounding EtO impact to the environment, technicians and end users. Yet these three critical questions are often missed. Find out what they are in our new blog..

The article provides an overview of six common methods used for sterilizing medical devices: wet/steam sterilization, dry heat sterilization, ethylene oxide (EtO) sterilization, sporicidal chemicals, glass plasma sterilization, and gamma/e-beam sterilization. It highlights the ideal devices for each method and emphasizes the importance of choosing the right sterilization method for each device.

This article provides an overview of the suitability of materials and medical devices for ethylene oxide (EtO) sterilization. EtO is considered an effective method for sterilizing gas-compatible devices, including both disposable and reusable medical devices. The article highlights the advantages of EtO sterilization, such as its ability to sterilize heat and moisture-sensitive devices and penetrate interior chambers or surfaces in contact with each other.

What’s trending in the medical device sterilization and packaging industry? Read the answers right here, including EtO regulations, packaging efficiencies and more.