The thermal sterilization processes are performed following tested protocols and suitable and certified instrumentation and are subject to very strict regulations which, among other things, require periodic maintenance and control of the machinery used, specifically autoclaves, ovens, sterilization tunnels, freeze dryers. , etc.
The purpose of this periodic activity is to demonstrate that the process is repeatable and reliable over time and perfectly capable of guaranteeing the desired results.
The performance qualification involves the analysis of all the process variables to which the products subject to sterilization are exposed, naturally including the Temperature variable.
Inside the chamber, temperature probes are inserted, sufficient to obtain the thermometric mapping of the chamber itself and some sterilization cycles are then “launched” at preset temperatures for at least 3 times, in order to verify the repeatability of the test.
The temperatures chosen are not random or approximate, but are those that guarantee the positive outcome of the sterilization process performed (for example for autoclaves at 121 ° C or 134 ° C depending on the reference load) and must be respected with extremely high tolerances rigid.
It is therefore of fundamental importance to choose the appropriate temperature sensor, since it must be extremely accurate and reliable sensors, something that many users do not take into due consideration.
The most suitable temperature sensors for these processes are Copper-Constantan Type “T” thermocouples (NBS125 & IEC584-2 & ASTM E230 Standards) as they are more accurate than other thermocouples, as per 590 NBS circular.
Depending on the type of insulating material (TeflonTM or Kapton), the “T” type thermocouples are used for the validation of steam autoclaves, ETO sterilizers, freeze dryers, dry sterilizers, etc …
CAP IT manufactures ULTRA-PREMIUM “T” type thermocouples for thermal validation, with very high reliability and durability, using multi-wire cables (stranded) with 3 and 7 wire conductors, individually insulated and with PTFE or Kapton outer sheath, made with materials with the highest purity and homogeneity available on the market, to minimize measurement errors due to Cold-Working and non-homogeneity of materials.
The encapsulation of the thermocouple hot junction with the PTFE heat shrink or AISI capsule increases the life of the sensor.
The sealed measuring joint minimizes the risk of moisture penetrating along the wire (so-called condensation leakage) and the risk of oxidation of the thermocouple, extending its life; the risk of air entering the chamber through the thermocouple during the air removal phase in the autoclave is also minimized. The PTFE protection also prevents potential errors due to improper grounding.
Further info on request.