Biotech drugs are currently the fastest growing segment within pharmaceutical and biotech pipelines, with approximately 60-70% of these drugs being delivered in pre-filled syringes or similar delivery devices. These biotech drugs are often highly sensitive to environmental factors such as temperature, vacuum, and sterilant ingress, necessitating careful consideration of the sterilization methods used.
Nitrogen dioxide (NO₂) sterilization presents an advantageous alternative for these drug-device combination products. This method sterilizes at low temperatures (10 °C-30 °C), making it suitable for temperature-sensitive biotech drugs. Additionally, as a gas sterilant, NO₂ can effectively reach complex geometries within devices, providing thorough surface sterilization with minimal to no ingress into the syringe. The process can operate under a wide range of vacuum conditions (20 Torr – 500 Torr), which is ideal for pressure-sensitive delivery devices.
Selected by the FDA for Innovation Challenge 1 – Alternative Sterilization Methods (to ethylene oxide) in November 2019, nitrogen dioxide has gained recognition as a viable sterilization option. This webinar aims to guide participants through the assessment and validation of pre-filled syringes using NO₂ sterilization.
The session will cover several critical aspects:
- Assessment of Pre-Filled Syringes: An in-depth look at what should be considered when evaluating pre-filled syringes for NO₂ sterilization.
- Validation Considerations: Key factors to address prior to initiating the sterilization validation process to ensure comprehensive and successful outcomes.
- Applicable Guidelines: An overview of the relevant ISO and TIR guidelines that govern the use of NO₂ for sterilization, ensuring compliance with industry standards.
- Case Study: Presentation of a recent case study highlighting the sterilization validation of a pre-filled syringe using NO₂, demonstrating practical application and benefits.
Participants will gain valuable insights into the practical and regulatory considerations of using nitrogen dioxide sterilization for biotech drug delivery devices. This knowledge will help ensure the safe and effective sterilization of sensitive biotech products, maintaining their integrity and efficacy.