STERILIZATION

SterilizationBio offers a full range of sterilization process development, validation and implementation services as described below 

Sterilization Technologies

• Radiation: Gamma, Electron Beam, X-ray

• Ethylene Oxide

• Supercritical Carbon Dioxide

Services provided include:​

• Manufacturing process development to produce product suitable for sterilization

• Engineering studies to assess sterilization effectiveness and product functionality

• Sterilization validation management including protocols, reports and project coordination

• Package and product stability study protocol and report development

• Sterilization standard gap analyses

• Establishing and maintaining product families as a least burdensome approach to sterilization validation and maintaining effectiveness.

• SOP development for routine sterilization shipping, contract sterilization, and product release