PT  - JOURNAL ARTICLE
AU  - Gillet, Annick
AU  - DeMent, Aaron
AU  - Haghedooren, Erik
AU  - Offermann, Eric
AU  - Tsakas, Ross
TI  - Nitrogen Dioxide Sterilization is a New State-of-the-Art Sterilization Technology to Control Contamination Risks From Your Prefilled Devices and Combination Drug Products
AID  - 10.5731/pdajpst.2025.25205
DP  - 2025 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 244--245
VI  - 79
IP  - 2
4099  - http://journal.pda.org/content/79/2/244.short
4100  - http://journal.pda.org/content/79/2/244.full
SO  - PDA J Pharm Sci Technol2025 Mar 01; 79
AB  - Prefilled Devices and Combination Drug Products, particularly those with integrated fluid paths or for specific Therapeutic Areas like Ophthalmology, may require final sterilization. Nitrogen Dioxide is a ground breaking novel sterilization technology designed to suit sensitive Prefilled Devices and Combination Drug products. This innovative sterilization process runs at ambient temperature and uses very low sterilant concentration. A SAL ≤10-6 is achieved in a few minutes of exposure, making this new technology highly efficient, without penetrating the drug reservoir. A case study will be shared, illustrating a validated process. This new modality will provide manufacturers with a new gas alternative to consider for their drug product to help ensure product safety for use in patients.