Summary of Methods in the Pharmaceutical Industry

Release time：2015-04-18

Sterilization refers to the method of killing or removing living microorganisms from articles using appropriate physical or chemical means. This method is applicable to articles during the manufacturing processes of sterile products, preparations, raw materials, excipients, and medical devices, among others.

Sterile items are defined as those in which no microorganisms are present. However, for a batch of products, sterility cannot be either achieved or verified by testing, since it is impossible to perform sterility testing on packaged products. In fact, physical and chemical testing methods have demonstrated that the kill curve follows a logarithmic pattern; therefore, the sterility standard for a batch of products is generally defined in probabilistic terms as a level of contamination units that is sufficiently low to be considered acceptable, typically expressed as the post‑sterilization survival probability—known as the Sterility Assurance Level (SAL). The SAL for the final product should generally not be lower than 10⁻⁶, meaning that the probability of surviving microorganisms must not exceed one in a million. The SAL is closely related to the quantity and characteristics of microorganisms present in the product; consequently, throughout all stages of production, appropriate measures—including filtration and other techniques—must be implemented to minimize contamination of the product and keep it within specified limits. The sterility level attained by the finished product can be confirmed through validation.

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