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.
Sterilization: What you need to know
- 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/exposure time is crucial. If the sterilization time is too short, microbiologic life remains in the product, but if it is too long, the product may be damaged or destroyed.
- The key basic parameters for sterilization are the lethality value (F0 value) and the holding/exposure phase time duration.
- Warm-up phase
Temperature increase in the autoclave to +121 °C, for example. Depending on the product, venting cycles (pre-vacuum cycles) are required.
- Sterilization/exposure phase
The sterilization temperature is maintained for a defined period of time (holding phase) during the sterilization/exposure phase. Depending on the product, this time may vary from a few seconds to several minutes.
- Cooling phase
Cooling of the product to removal temperature. Depending on the product, vacuum cycles can also be used in this phase 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
- The standards above 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 production and manufacturing of medicinal products
- testo 190/191 system consisting of robust data loggers, easy to use 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
Where do you use sterilization processes?
In the food industry:
testo 191 HACCP data logger system
In the pharmaceutical industry:
testo 190 CFR data logger system