Microbiological and Particle Risk Assessment of a Cleanroom and Aseptic Filling Line

AS-Advisory-Paper_110117_Page_6.jpgA theoretical case study involving the steps of classification, risk assessment and monitoring plan verification was conducted. The classification used total particle concentration and environmental monitoring data and established routine microbiological and particle monitoring points for an aseptic filling line. The cleanroom utilized Grade A, B, C and D zones.

After classification, a risk assessment of the defined monitoring points was performed. The points' number and criticality were assigned using risk assessment methodologies such as FMEA, and the monitoring frequencies for individual locations were then calculated.

It is essential for a monitoring program to meet current regulations and good manufacturing practices for stable operation. Emerging practices should also be understood and planned for when verifying the performance of the final monitoring plan.

In order to provide complete functionality, this web site needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site including but not limited to: log in, buy products, see personalized content, switch between site cultures. It is recommended that you allow all cookies.