Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to startup as soon as possible once the project is completed but also to achieve steady-state throughput as quickly as possible after the startup begins. This type of startup is what is called a “Vertical Startup.” In practice, vertical startups are rare because management teams typically focus their attention on having the facility and the equipment qualified in time to meet the process qualification milestone. Richard Tree reveals that the consequences of this thinking are that a broad range of workstreams are often neglected or receive inadequate attention although they are critical to startup. Workstreams like staffing, training, procedure development, supply chain, analytical methods, etc. must all be ‘ready to go’ by this important milestone.

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‘Digital Transformation: The Modern Pharmaceutical Control Tower‘

Vertical Startups do not happen by accident. The first step requires management teams to transition their focus from a process qualification milestone to an Operational Readiness milestone. Once this happens, operations departments can achieve a Vertical Startup by applying the principles of Operational Readiness, a proven methodology used across the spectrum of manufacturing industries. Not only is it a proven methodology, it is central to the practice of technology transfer. Despite its importance, Operational Readiness is often not fully understood, not correctly applied, or is confused with the principles of Operational Excellence.

The primary objective of this article is to inform the reader (particularly those who are a part of management teams) about Vertical Startups and how Operational Readiness is the organisational state that needs to be reached in order for vertical startups to exist. The secondary objective is to help the reader build an understanding of Operational Excellence in addition to Operational Readiness. The series will also highlight the need to: (1) design systems which are comprised of production-friendly equipment that is easy and safe to maintain and operate; (2) implement organisational systems to allow for the swift and smooth startup of new equipment recognising safety, product quality, and cost; and (3) decrease the Life Cycle Cost (LCC) of equipment and facilities.

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