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NO2 Sterilization as Part of a Batch Release Process for Clinical Trials
The nitrogen dioxide (NO2) sterilization process is an ideal candidate for the sterilization of the external, gas-accessible surfaces of prefilled syringes. A process has been designed to accommodate temperature and pressure-sensitive products such as drugs or biologics in prefilled syringes. The NO2sterilization process is applied to the prefilled syringes (or other containers) with minimal vacuum at room temperature. These attributes minimize the risks of sterilant ingress via stopper movement and thermal degradation of the product. The NO2sterilization process rapidly inactivates microorganisms on surfaces, and readily aerates from product, which results in relatively short times at room temperature for product batches.
Regulators have been requesting manufacturers to sterilize the exterior surfaces of prefilled syringes that are intended to be used in the sterile field; particularly in ophthalmic applications. The NO2single batch release process allows manufacturers to expeditiously obtain product for clinical trials without undergoing a full validation. The process closely follows AAMI TIR16, which describes the batch release process for ethylene oxide sterilization. The sampling rationales, along with the microbiological and process data will be discussed, as will the results of product sterility and NO2ingress testing
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