Matrix Approach To Media Fills

Matrix Approach to Media Fills

Author: Edwin Hoppenbrouwers is Catalent’s Director of New Product Development for Sterile Technologies

Summary: This presentation will discuss the description of a media fill matrix approach, including:  bracketing, use of FMEA (Failure Mode Effects Analysis) in determination of worst case media fill conditions, tracking and frequency, along with the introduction of randomized media fills. Also considering the overall program strength and ability to fulfill the needs of multiple stakeholders (customers, regulatory agencies (EU std vs. PDA recommendation) will be discussed in detail.