|Kishore (right) on the job|
While the term “commissioning” is sometimes used differently from sector to sector, and even from client to client, understanding commissioning within the pharmaceutical industry makes it clear how specialized this kind of work is. Obviously, manufacturing drugs requires a highly rigorous process to assure their consistent quality and safety. Commissioning in this context often includes qualification and validation, sometimes interchangeable terms, referring to a robust analysis process where qualification documents or protocols, often written by our group, are subject to regulatory agency review. Qualification involves an extended period of time, either to assure that previous testing results are still valid or to determine that new equipment is performing consistently over time.
|The complex mechanical systems of pharmaceutical|
facilities require diligent commissioning
Commissioning is performed for new buildings and for older ones, ranging from assessing proposed systems to providing field investigations for existing facilities. Especially significant are the building controls, those systems that run and monitor HVAC and utilities for temperature, humidity and air flow, which must operate at optimum efficiency. As such, commissioning engineers are often involved right at the start of a project—developing a commissioning master plan and providing a thorough design review, helping clients mitigate risk before problems arise. In other cases, we provide management and oversight once the facility, its utilities and equipment are constructed.
This interface and coordination of engineering and construction disciplines is challenging and very satisfying, especially since we work closely with clients to gain a thorough understanding of their products/services, processes, stakeholders and users. It’s a special kind of work and requires a particular type of person. I appreciate spending a majority of time in the field, at the client’s site, rather than sitting at a desk in the office. And since we serve clients with facilities across the country, the job requires extensive travel, which I really enjoy.
While this isn’t the profession I went to school for (I studied economics, actually), it’s been extremely rewarding and exciting. And as sustainability becomes even more ingrained in the building and construction process, I see my job and what commissioning can do for clients only growing.