Impact of Single Use Technologies on Automation and Information Management

One of the conversations happening among pharmaceutical and biotech manufacturers is around the “facility of the future”. I caught up with Emerson’s Gary Mitchell, a consultant on the Life Sciences industry team. He shared some of the trends prompting this relook at how manufacturing processes are designed.

Through modular, hybrid and off-the-shelf designs such as GE KUBio and the NNE Standard Facility, the speed of construction has significantly increased. This allows new facilities to be built closer to the population centers where the medicines will be used.

Single Use Bioreactor (SUB) Control System

Source: Broadley James, http://jimc.me/11FLcah

From a production process standpoint, upstream yields continue to increase as bioreactors shrink in size and increase in number to provide parallel production paths. Many of the production processes including clinical, bulk, fill/finish, and packaging facilities are being consolidated into a single location. And, some of the production equipment, such as bioreactors, centrifuge skids, and chromatography skids can be disposable/single use technologies (SUT).

These SUTs may come with instrumentation and controls included, as do disposable bags used for media and buffers. These changes prompt several questions:

  1. How are pharmaceutical and biotech manufacturers managing and tracking these instrumentation and controls from an automation perspective – are DCSs required as much?
  2. Reduced use of on/off valves required for clean-in-place (CIP) / sterilize-in-place (SIP) reduces the need for I/O and associated control logic–does this also reduce the need for traditional DCS?
  3. How are transfers between equipment handled and tracked with less automated on/off valves?
  4. How is material and equipment usage and genealogy being captured–via manufacturing execution systems (MES)?
  5. Are we generating more paper records – again, more need for MES?

Where centralized automation captured much of the data required for the electronic batch records, will the pharmaceutical and biotech plants of the future collect and organize this data via the MES?

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