Publications

An Industrial Forensic Approach to Particulate Characterization for Manufacturing and Quality Assurance Investigations

Publication Information:

Wolfe, Julianne and Karen Smith, An Industrial Forensic Approach to Particulate Characterization for Manufacturing and Quality Assurance Investigations, presented at Golden LEAF Biomanufacturing Training and Education Center (BTEC), May 2011.

Year: 2011

Topics: Biopharmaceuticals, Laboratory Services, Materials Characterization, Quality Control

Foreign particulate matter (FPM) can affect product efficacy but more importantly product safety particularly within certain life science industries. The importance of characterizing FPM is evidenced by numerous warning letters and consent decrees recently issued by the FDA for a lack of attention to this issue. Traditional methods for detecting FPM focus on the size and quantity of these materials rather than their identity. Furthermore, traditional methods are typically employed at the end of production on final or near final products which does not support an overall understanding of the process. Methods developed for criminal forensic trace evidence analysis provide an effective and efficient way to identify FPM. The concepts utilized for trace evidence analysis can easily transition into an established and proven testing regimen for the life science industry. Additionally, utilizing an industrial forensic approach can be employed at various times in the product lifecycle. This versatility will assist in building quality into products from the beginning rather than testing at the end as is the basis for an industrial forensic approach. Industrial forensic methods can easily be implemented in new FPM programs but can also be easily introduced into existing FPM programs using a retroactive approach. The information that is provided can be coupled with results from traditional methods to ensure product quality. Customized data management systems can be used to further organize information and to facilitate investigations into trending and source sampling. The principles of an industrial forensic approach for FPM characterization will be discussed as well as example case studies.