Although automation has taken hold slowly in the life sciences, it has come to play an increasingly important role in keeping the drug industry moving ahead. While other industries such as general chemicals and specialty chemicals consistently moved to apply new technologies and improve manufacturing performance, the life-science industry lagged behind. But in the past few years, the pace of innovation has accelerated greatly, and it shows no sign of slowing down. This article will look at major automation trends in the life-science field from 1977 to the present and provide ideas about possible developments in the years to come.
The old days (pre-1977)
The first distributed control systems (DCSs) emerged in 1975, and they were used mostly in the chemical industry at first. DCS gained popularity in the life-science industries in the latter part of the decade and in the early 1980s. The US Food and Drug Administration was ramping up its regulatory requirements, and automation was seen as a good tool to facilitate compliance. The pursuit of automation accelerated when batch-control automation and batch-unit operations control became available in 1983. The ability to use configurable, off-the-shelf (OTS) software to write sequences, take automatic actions based on failure, create recipes, and synchronize parallel-unit operations delivered significant improvements to life-science manufacturing. Implementing automation was a large, challenging task because control rooms and wiring were centralized. Everything was linked to a combination of a main control room and a massive main wiring hub. Thinking about batch software logic and failure handling was new to many people.
The late 1980s and early 1990s
Once people gained experience automating batches, batch standards began to be developed. The goal was for everyone to talk the same language, use well defined terms, and share a common architecture. The first batch automation standard, S88 (on which work had begun in 1988), was approved by the Instrument Society of America in 1995. S88 was initially implemented in two applications, PID's "Open Batch" real-time batch-recipe execution service and Consilium's "Director" manufacturing execution system. These applications became the basis for many of the batch-automation solutions that developed around the S88 standard. In addition, the World Batch Forum was founded in 1994. This forum for the batch-process industries focuses on best practices for automating and applying technology to batch manufacturing.
By the mid 1990s, several product platforms built on these new standards began to appear. The concepts of class-based configuration software were developed. Class-based software facilitated the establishment of common libraries of building-block modules linked to unique instances of the modules as they are applied. The library modules were then quickly replicated, but change control could also easily be applied. Because the various instances can maintain the characteristics of their class, it was easy to change them and document the change. Although not initially applied to their full extent, these concepts enabled the modular construction approach used by most life-science companies in the early 2000s.