Sterilization: What you need to know
There’s a lot to learn – let alone keep in mind – when it comes to the challenging task of sterilizing food or pharmaceutical products. Our experts have compiled the most relevant information for you here.
During sterilization, food or pharmaceutical products are rendered free from viable microorganisms.
Temperature and pressure values of up to +134 °C or 3.5 bar can occur
Implementing the correct sterilization time is crucial. If the sterilization time is too short, germs remain in the product, but if it is too long, the product may be damaged or destroyed
The key parameters for sterilization are the lethality value (F0 value) and the holding phase duration
Warm-up phase
Temperature increase in the autoclave to, for example, +121 °C. Depending on the product, venting cycles (pre-vacuum cycles) may be required.
Sterilization/Exposure phase
In the sterilization/exposure phase, the sterilization temperature is maintained for a defined time range (holding phase). Depending on the product, this time can vary from a few seconds to several minutes.
Cooling phase
Cooling the product to the removal temperature. In this phase as well, depending on the product, vacuum cycles can be used to ensure the drying of a product.
Physical and biological evidence that the sterilization method is suitable for the product
The validity of the procedure must be verified regularly, e.g. when it comes to steam sterilization in autoclaves by temperature data loggers (lethality rate), pressure data loggers (saturated steam quality) and biological indicators
Positioning the data logger’s probe tip in the core of the item being sterilized
DIN EN 285, DIN EN ISO 17665, DIN EN 13060, DIN 58950, EU GMP Annex 1, PDA Technical Report No. 1, No. 26, 30, 61
These standards describe requirements for the equipment, specifications for the integration and efficacy of the processes as well as methods and procedures in order to ensure quality assurance in the manufacture of medicinal products
testo 190/191 system consisting of data loggers, software and multifunction case
Measuring range -50 to +140 °C
Simple calculation of lethality rate, holding phase, and saturated steam quality via software
A variety of accessories enable the logger to be positioned optimally during core temperature measurement
How can our data logger systems help you specifically?
Contact
Where do you use sterilization processes?
Pharmaceutical industry
In the pharmaceutical industry: testo 190 CFR data logger system
Downloads for the testo 190 CFR data logger system
Whitepaper, application example, product brochure and factsheet
