Growth in BI at Moist Heat Terminal Sterilization

Terminal sterilization is the reliable process to assure the sterility of the product. Regulators more relay on the Moist heat terminal sterilization process than aseptic processing. In terminal sterilization product sterilized in the final container. Terminal sterilization should be utilized when the product and container/closure system are able to withstand the terminal sterilization process.

Note: Kindly attend the Survey On “Moist Heat Terminal Sterilization” Validation and process control. Link provided below, https://lnkd.in/gbzaPnR, Intend of this servery to understand the practices followed by Indian Pharmaceutical industry for Moist Heat Terminal Sterilization.

The terminal sterilization process usually involves filling and sealing product containers under high quality environmental conditions designed to minimize microbial and particulate contamination of the product. This minimization of upstream bioburden reduces the challenge to the subsequent sterilization process. In most cases, the product, container, and closure have low bioburden, but are not sterile at the time of filling. The product is then subjected to a sterilization process in its final container.

In this article we will identify the most probable cause which can lead failure of biological indicator (BI) after TS sterilization study.

All the 6M categories are summarized briefly in the Table-1 : Factors can influence the performance and out come of Moist Heat Terminal Sterilization ,

Figure 1: Failure assessment through fishbone (ishikawa) on BI Growth identified after validation studies of moist heat terminal sterilization.

Related articles :

1. Concept of Terminal Sterilization
2. Growth in BI for Moist Heat Terminal Sterilization Validation