The term “parametric release” is commonly used when referring to sterility assurance; however, it is often misinterpreted. Let’s take a look at what parametric release is and how data loggers play an integral part in product validation.
The term “parameter” is defined as “a numerical or other measurable factor forming one of a set that defines a system or sets the conditions of its operation.” The second half of the phrase is “release”; Oxford’s English dictionary defines this as “to allow or enable to escape from confinement; set free.” Hence, the phrase “parametric release,” when used regarding product sterilization, describes a process that includes measuring and recording the parameters of product exposure to validate the sterility before releasing the product into the public.
Sound familiar? Data loggers are the primary tool used for the measuring and recording of parameters during sterilization cycles. The formula for successful sterilization is directly tied to temperature levels and length of exposure, among other measurable variables that ensure microbe depletion. Once the cycle is complete, the loggers are connected to a computer where data can be immediately analyzed to determine if the sterilization cycle was successful. Once this determination is made, the sterile products can be released.
If a company does not employ parametric release, then biological indicators are used to validate the sterilization cycle instead. Unfortunately, biological indicators must be given adequate time to mature (typically between one and two weeks) to determine if the product is sterile. This means that for the time that the biological indicators are left to mature, the product being sterilized cannot be considered sterile until the results of the biological indicators come back. This typically delays product distribution for weeks after the sterilization cycle is over. Of course, this poses an array of problems from an efficiency standpoint; having finished goods sitting around raises costs of storage and increases lead times.
Performing parametric release does not increase risk at all; in fact, cycles are still performed in the same way and biological indicators are still used. The difference is that products can be released as sterile without having to wait for the biological indicators to complete their study period. Records are retained for all cycles so that data can be recalled any time for validation of sterility and mated with the results of the biological indicators.
MadgeTech data loggers and analytical data logger software assist users in efficiently performing parametric release. Sterilization loggers can be configured to record date- and time-stamped readings at user-set intervals. The resulting data allows users to ensure sterilization chambers are reaching the correct temperature, humidity and pressure levels for the required durations throughout the entire cycle.