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 MoreNate Smart
Process Specialist
St. Louis, Missouri

Nate Smart is a Process Specialist located in the Central region. He has 10 years of experience with a focus in aseptic filling of pharmaceutical drugs, isolated fill line design, and regulatory requirements for aseptic operations in GMP facilities. Nate specializes in taking diverse owner requirements, site limitations, and project needs and matching them to creative, integrated solutions without creating costly and needlessly complex overengineered designs. This means right sizing the sterile core and supporting operations, analyzing the cost-benefit of the latest trends in filling technologies, barrier systems, and primary packaging materials. Particularly in a pandemic impacted world, this includes analyzing supply chain limitations for both drug product equipment and components.
An integrated fill line is typically the most complex and costly piece of drug product equipment. Two of the most critical aspects in fill line design and procurement for a design consultant are URS development and facility integration. Nate is skilled at matching owner requirements to the latest innovations in fill line and barrier technology, and scales fill line throughput against owner requirements to ensure capital investments are efficient over the lifetime of the equipment. Every project has its own challenges and opportunities, so a keen understanding of current market conditions and vendor offerings are critical for success. In addition to his technical understanding, Nate is committed to the success of each project. This means obtaining and coordinating the needs of all key stakeholders. Whether it’s the project architect or the owner’s maintenance department, Nate communicates key design points and clarifies the impact of each decision on cost, schedule, and quality. A project only succeeds if the entire team works together.
Insights By Nate
The difference between aseptic processing and terminal sterilization
Both aseptic processing and terminal sterilization remove contamination from drug products, but the two methods are not the same, and they are not interchangeable.
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