When it was first released in the 1970s, Annex 1: Manufacture of Sterile Medicinal Products filled an important gap in the regulatory landscape by formalizing EU regulators’ expectations for maintaining product sterility through facility design and operation.
Read MoreLuke Stockhausen
Lead Process Engineer
Raleigh, NC
With over a decade of engineering experience in parenteral and biopharmaceutical manufacturing, Luke Stockhausen is an integral part of CRB as a Lead Process Engineer.
Luke brings his hands-on client experience to CRB. His understanding of facility and equipment design, construction, commissioning, qualification, equipment lifecycle management, and day-to-day production support enables him to deliver robust, CGMP-compliant, and reliable equipment and facilities to CRB’s clients.
His extensive knowledge of parental pharmaceutical manufacturing process includes manual and automated solution preparation suites, filling support areas and equipment, and aseptic filling. Luke is a member of ISPE and participates in BioPhorum. He provides knowledge across the life sciences industry that continues to provide growth for CRB and the incredible projects the team puts together. His end goal on projects is to always provide high-quality treatments for patients.
Luke is a Wisconsin transplant to Durham, North Carolina. On the weekends, you may catch him walking to the downtown farmers market in search of ingredients for a recipe to share with friends and family.
Insights By Luke

For efficient aseptic and sterile manufacturing, process architects are key
Designing an aseptic and sterile manufacturing facility that meets regulatory requirements takes expertise. Designing it to operate efficiently is even more challenging. Process architects are an important part of the team that can help you meet that challenge with confidence.
Read More