RT Journal Article
SR Electronic
T1 Nitrogen Dioxide Sterilization is a New State-of-the-Art Sterilization Technology to Control Contamination Risks From Your Prefilled Devices and Combination Drug Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 244
OP 245
DO 10.5731/pdajpst.2025.25205
VO 79
IS 2
A1 Gillet, Annick
A1 DeMent, Aaron
A1 Haghedooren, Erik
A1 Offermann, Eric
A1 Tsakas, Ross
YR 2025
UL http://journal.pda.org/content/79/2/244.abstract
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.