Understanding the requirements and nuances of sterility testing

Sterile pharmaceutical manufacturing generally comprises a complex, multi-step processing system in which significant risks from microbial contamination are presented by diverse sources. To reduce these risks, Annex 1 expects that a holistic contamination control strategy (CCS), based on a risk assessment is developed and implemented. The CCS demonstrates an organization’s understanding of all of their design, technical, procedural and organizational controls and identification of potential risks or gaps that require remediation to improve the overall level of sterility assurance.

The requirement for facilities to have a specific CCS and application of QRM are two of the key features of Annex 1. Developing and maintaining a holistic CCS requires in-depth knowledge and understanding of the pharmaceutical process as a whole including how these processes are subject to change such that all risks can be identified along with the associated contamination controls.

Ultimately, our experience shows that it is the overall effectiveness of the sum of the contamination controls in place that provides a higher level of assurance that a product is sterile. A solid contamination control program using appropriate design, validated control systems, and a scientifically sound environmental monitoring program are more meaningful than the sterility test.

From our experience in the industry, implementation of a robust CCS based on scientific knowledge also provides benefit for the manufacturing of other non-sterile products that require control and reduction of microbial contamination to meet the requirements of product quality.

What challenges has your organization encountered with sterility assurance? And how well do you understand the CCS requirements and assessment of sterility assurance issues? We would be happy to hear about your experiences and any challenges faced. Contact us now!