Pharmaceutical Technology magazine published an interesting article by Emerson’s Bob Lenich and Christie Deitz. The article, A Look at 30 Years of Change in Pharmaceutical Automation, recounts the changes affecting Life Science manufacturers from the late 1970s though today. I joined the world of process automation in the early 80s as a summer systems engineering intern in offshore oil and gas production and this article brought back some memories of the amazing changes we’ve seen.
I’ll highlight some items from the article to see if it generates any nostalgic thoughts for you.
Although the distributed control system came along in the mid-70s, Bob and Christie note that most life science companies used pneumatic and single-loop electronic controllers. Data was collected manually or with circular and strip charts.
With growing U.S. Food and Drug Administration (FDA) regulations through the late 70s and early 80s, the DCS began to be seen by life science manufacturers as a tool to help comply.
Batch-based automation systems, the first one being the PROVOX system, came out in the early-to-mid 80s to help with sequencing, failure handling, parallel unit operations, and the creation of recipes.
Just a few years before I recall a little collaborative effort between IBM and Microsoft being introduced to the market (wow a 4.77MHz CPU!) This would have some impact in our industry in the following decade as commercially available technologies (COTS) were incorporated.
Toward the later part of the 80s and into the 90s, standards began to play a larger role. ISA-88 (S88), a batch automation standard was important to life science manufacturers. The digital busses including Foundation fieldbus were developing, and Microsoft operating systems began to make their appearance in systems like the DeltaV system. For communications, the OLE for Process Control (OPC) standard became the way to connect Microsoft-based clients and servers–a big improvement over earlier generation DDE communications technologies.
Automation systems became increasingly modular with class-based configurations. These technologies would help the trend toward more modular construction techniques that brought production on-line quicker compared with prior construction and engineering methods.
Regulations continued to advance to try to address concerns around system, production and data management through the balance of the 90s. Efforts began on the ISA-95 (S95) standard to better define the integration of enterprise and control systems.
These regulations had a positive impact in building competency around data security, record security, lot tracking, and overall batch management. The downside was that it placed the focus of life science manufacturers on meeting regulations rather than continually improving their manufacturing operations compared with other industries.
The FDA’s Process Analytical Technologies (PAT) initiative addressed this by changing the focus from meeting regulations to improving operation. The FDA’s cGMPs for the 21st Century added in using a risk-based approach to these improvements. As part of this initiative, they encouraged the use of innovative technologies. We’ve addressed a number of these innovations with respect to PAT in earlier posts.
Bob and Christie closed the article with a note of how flexibility and the integration of automation with the business-level systems is becoming increasingly important as life science manufacturers move from organic-based synthesis to biologics to continue to develop vaccines and medicines to address our health needs.