Ellab Validation Solutions Both the E-Val Pro thermocouple system and the Track Sense® Pro wireless data loggers are well suited for the validation of autoclaves.
For validating the sterilization process according to the predefined acceptance criteria, the Val Suite™ Pro software is a valuable tool.
In addition to achieving minimum and maximum temperatures for set time periods, there are a number of other measurements which many users find critical.
These include the equilibration time, which is the difference between the first sensor achieving sterilization temperature and the last.
Guidelines state that 11 temperature-measuring points are needed when performing a heat distribution study of an autoclave that is from 1.5 to 2.5 m3.
This number is reached by placing one sensor in each of the eight corners in the autoclave, one in the center, one close to the drain and one next to the autoclave’s temperature sensor.
This could be during batch production, cycle development and validation.
For this reason, Ellab offers a wide range of fixtures and fittings.
In this blog we’ll explain why Operational Qualification is another crucial step in validating your autoclave.Autoclaves can be used for sterilization of liquids in various containers such as bottles, vials, ampoules, bags and medical equipment.In most cases it is necessary to monitor the temperature of the product and the pressure of the autoclave during sterilization.This means calibrating shortly before the validation run (referred to as Pre Calibration) and then checking the accuracy afterwards to ensure that they are still within predefined tolerances (referred to as Post Calibration).Using the built-in calibration functionality, users can calibrate the Ellab sensors at regular intervals.A critical factor when validating autoclaves is the calibration of temperature sensors.It is essential that the user can demonstrate that the sensors were within an acceptable accuracy when they were used.Common sterilized products and containers are: An autoclave is a vessel that uses pressurized steam to heat the product to achieve sterilization.Autoclaves come in a wide variety of sizes, from small bench-top laboratory autoclaves to large production autoclaves.For sterilization to be effective the steam has to be saturated as this transfers most energy from the steam to the product.To facilitate the validation of this parameter the Val Suite™ Pro software includes saturated steam analysis that correlates temperature and pressure automatically.