• Quality Systems
• Regulatory Compliance
• Risk Management
• Sterilization
• Cleanrooms & Controlled Environments
• Clinical Services
• Biocompatibility
• Buy Training Modules
• Process Validation

Services: Sterilization

Protocol development for:

• Sterilization efficacy studies
• Comparative resistance studies
• Sterilization validation for the following: Gamma, EtO, moist heat, liquid chemical, vaporous hydrogen peroxide, E-Beam
• Contract sterilizer audits

QA Consulting provides complete sterilization validation services for medical device manufacturers seeking compliance to national and international standards. We can assist with all phases of sterilization including process development, validation, laboratory testing, and the investigating of sterilization failures. 

We have a practical approach and believe that data analysis is a critical to implementing sterilization specifications and understanding key variables effecting product sterility.

Our consultants have extensive expertise in the following types of sterilization:

• Ethylene oxide
• Radiation
• Electron beam
• Moist heat
• Liquid chemical sterilants

 We will develop and manage all phases of a sterilization validation, including:

• EtO cycle development and process validation
• EtO comparative resistance studies
• Validation of moist heat for terminally sterilized devices and re-usable devices
• Implementing standard operating procedures for control of sterilization processes
• Selection and auditing of contract sterilizers and laboratories

Our microbiologists have extensive laboratory experience and offer clients assistance with:

• Biological indicator testing
• Bioburden testing and method validation
• LAL testing