Life Sciences Forum Flexible Manufacturing RED breakout session notes PLEASE comment to add notes and continue the discussion

Flexible Manufacturing

The consumer demand for companies to provide better, affordable, and additional medicines globally has pressured manufacturers to innovate manufacturing processes that are efficient and flexible. To address this consumer demand, manufacturers aim to produces medicines close to the consumer. This means that more plants sprinkled strategically across the world will be producing multiple products appropriate to that market. Central to this concept is to produce multiple products from the same set of assets - hence the tem Flexible manufacturing. There are several aspects required for a successful flexible manufacturing strategy. The glue to this strategy is automation. This session will include a group discussion where individual ideas will be unveiled and synthesized into one coherent thesis. The sub topics of the group discussion are:

• Define the flavors of Flexible Manufacturing (there are several approaches)

• Challenge the hypothesis. Do we really need FM?

• Where/How does Instrumentation, Process Control, Operations Management/MES, and Data Management fit in FM (or what are the basic requirements for….)

NOTES from the RED breakout group

WHAT is it?

Ability to produce different products in different equipment with little effort

Compliant qualifications the first time

Single use equipment

Portable equipment

Standards & concepts

WHY

CMO

Capacity utilization

Product development

Standard platform

Fast to market

Challenges

Complex configurations

Costs

Equipment requirements

Equipment flexibility

Process changovers / time

Cleaning and validation

Scheduling and forecasting

Batch recipe generation

Change management

Managing shared equipment

Solutions

Justification

Single use equipment

Portable equipment

Define interfaces

Standard modules

Flexible piping schemes

Standard concepts