What’s currently happening in automation and where are we going? Will batching be gone forever in favor of single-use components in a continuous process? Will we be wearing Google glasses and following instructions from some brainy robot with our heads in the electronic cloud?
The biotech industry has benefited enormously over the past 30 years due to rapidly advancing improvements in automation but particularly so in the past five years. Advances in PLC and DCS systems along with the advent of the PC and more powerful software have reduced the cost, ease and improved the ruggedness of automation. Electrical analog (4-20mA) signals from measuring devices are being replaced with digital signals such as Ethernet/IP resulting in much more accurate measurements that are not susceptible to drift or EMI interference.
In addition, smart sensors enable remote calibration and troubleshooting. Proprietary networks are being replaced by Ethernet and standards such as OPC are making it easier for disparate devices to communicate with each other.
Advances in software standards such as the S88 batch process control standard have made it easier to program multiple systems by reusing the same validated code. By reusing validated control modules and equipment modules in accordance with S88, the amount of testing and validation is significantly reduced.
The past five years have seen significant changes in the biotech manufacturing process as well. The implementation of single-use disposable systems with their attendant disposable sensors is now accepted practice. Traditional batching is giving way to continuous manufacturing. Automation is a key component in making continuous manufacturing function properly. Separate islands of automation are being networked so that all GMP data can be easily compiled in real time in one location.
Currently, biotech manufacturers are using the cloud to save and access their GMP data, such as alarm lists, historians and batch reports. In the next couple of years we will see entire MES systems being placed in the cloud. Additionally, smart glasses are now being used by operators to access SOPs and other pertinent information on the plant floor. In the future we will see these smart glasses on all operators collecting video and sound as part of the validation record. In addition, these glasses will enable remote troubleshooting by sharing visual information over the internet. They will also be able to color code connectors to guide the operator when making connections.
Finally, the method and process by which automation is purchased is changing. Hardware is becoming a commodity, interchangeable among different manufacturers. PLC and DCS systems can interface I/O from other manufacturers. Software is becoming more powerful and industry specific apps will be purchased and downloaded from customer web sites in the same manner that Apple apps are selected.
Now that I have whetted your appetite, join the local Chapters of ISPE and ISA on January 18 at Takeda in Cambridge for a walk through the history of automation from the early PLC’s into the present and future; and get all your questions answered.
For more information and to register for this program, click here.