Use Of QbD To Mitigate Risk In Parenteral Aseptic Fill/Finish Presented By Catalent Expert At PDA Conference

Use Of QbD To Mitigate Risk In Aseptic Parenteral Fill/Finish Presented By Catalent Expert At PDA Conference

Advanced Aseptic Filling Techniques Can Substantially Reduce Contamination

Somerset, NJ – March 10, 2014 —  Ms. Hope Mueller, Catalent Pharma Solutions’ Director of Quality and Regulatory Affairs, is to present at the 2014 Parenteral Drug Association (PDA) Europe Parenteral Packaging Conference, “Current and Emerging Technologies and Regulations,” which runs from 11th-12th March in Brussels, Belgium. Her presentation, “Embracing the principles of Quality by Design (QbD) to mitigate the risk of the parental filling process through Advanced Aseptic Processing,” takes place on Wednesday, 12 March 2014, from 8:00 – 8:30am.

“News of product recalls and warning letters appear frequently in the press and highlight the manufacturing challenges of aseptic parenteral filling,” she commented. “These challenges manifest themselves in the final container closure and stem from issues such as microbial and particulate contamination that can directly impact patient safety. Issues are often derived from the complexity in the preparation, handling, filling and sealing of container closures.”

Ms. Mueller’s presentation will look at ways in which the use of advanced aseptic filling techniques, such as those inherent to Blow-Fill-Seal (BFS) technology, can substantially reduce the leading causes of contamination through the ability to control the critical parameters and automating the filling process. The session will demonstrate how the risk of aseptic filling can be drastically reduced by leveraging the fundamentals of QbD and completely rethinking the approach to the traditional glass parenteral filling process through BFS. The presentation will highlight the key elements of this advanced aseptic technology, analyze the control parameters that assure sterility and highlight where automation eliminates human intervention in critical processes.  

Ms. Mueller has more than 17 years of quality and operational excellence experience in the pharmaceutical industry. The majority of her experience is in the parenteral and contract manufacturing space for major pharmaceutical companies including Eli Lilly, Baxter and Catalent Pharma Solutions. A microbiologist with Six Sigma Black Belt certification, Ms. Mueller has progressed through various global continuous improvement activities and quality management roles. In 2009, she joined the Catalent team as the Director of Analytical Services at the Woodstock site and is now the site’s head of Quality.
Further information on the conference can be found at: 

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit .

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