Ethylene oxide (ETO) is commonly used to sterilize plastic containers, but the effects of
residual amounts left after sterilization on protein therapeutics are still not well understood …

Ethylene oxide (EtO) is widely used in sterilization of drug product primary containers and
medical devices. The impact of residual EtO on protein therapeutics is of significant interest …

Materials from prefilled syringe systems—such as silicone oil, tungsten, glass, and rubber—
may enhance therapeutic protein aggregation and particle formation. Also, the sterilization …

Ethylene oxide (EO) gas is commonly used to sterilize medical devices. Bioavailable
residual EO, however, presents a significant toxicity risk to patients. Residual EO is …

Current approaches for validation of EtO sterilization cycles identified in ISO 11135 and EN
550 are scientifically deficient and result in full cycle times that are too short. This review …

Ethylene oxide gas is commonly used to sterilize medical devices, and concerns about
using this agent on biological systems are well-established. Medical devices sterilized by …

This study presents a comprehensive evaluation of process variables and integrates them
into a simple and direct application model. These data represent a more rigorous …

Ompi Pharmaceutical Systems sterilisation cycle (eg temperature, pressure, humidity, gas
concentration, exposure time, degassing, aeration time and determination of residuals) …

Purpose Following two cases of neutralizing antibodies to epoetin alfa in an investigational
clinical study, a small number of individual syringes of two drug product batches were found …

Ethylene oxide (EO) is a well-known sterilizing agent. However, only recently has its use
significantly emerged, based on its range of applications in the field of new medical device …