LETHAL RATE PRODUCT RELEASE

On-Site Work and Final Protocol/Report preparation for EO cycle development in compliance with ISO 11135 series. Sterilization Parameters are designed to meet your optimized product requirements. EO cycle development is completed through the lethal rate release cycles.

This method allows product to be released to market based on process records instead of the traditional biological indicator (sterility testing).

Pre-conditioning

• Establish time, temperature, humidity
• Loading pattern of the product and separation
• Maximum elapsed time prior to sterilization done

Conditioning

• Typically in the chamber itself; vacuum hold
• Establish time, temperature, humidity

Fractional Cycle

• Method A or B: Survivor Curve or Fraction Negative methods
• Partial exposure to achieve fractional kill to establish D-value
• Calculate the expected probability of survival

Sterilization

• Temperature and humidity of the sterilization load
• Ethylene oxide gas concentration
• Exposure time (commonly called “dwell time”)
• Perform 3x half-cycle run lethality and full cycle to confirm

Aeration

• Time and temperature maintenance for out-gassing
• Pressure changes required or needed
• Loading pattern of the product and separation