2/25/15 Much ado is being talked about in the micro world about micro factories. One such system was recently seen as a fully functioning cell that fit in a briefcase. These systems, small and compact all work on the premise of AVOIDING handling the micro parts too often or not at all. Micro parts that are created and put down in a bin, bowl, guide, or nest need to be picked up again, re-oriented and re-introduced to the mating component or components next in line for the assembly.
Each step that requires a micro part to be picked up and put back down adds error and given that they are micro parts, there isn’t much room for error. (This incremental error can be studied in a tolerance analysis which can be discussed on a project to project basis)
A few options exist to avoid or at least minimize micro part handling in a micro assembly:
1. Create a micro factory or automation cell with precise and miniaturized machines that enable ONE holding chuck or end-of-arm tool that interfaces with mechanical, electronic, and optical sensors to create a final micro assembly all within the space inside a cereal box.
2. Combine part to part geometry (stealing from Peter to pay Paul) in as few steps as possible (i.e.valve/pump combinations, onboard valve/chip combinations, needle/sheath combinations).
There was a recent article in Pharma iQ that refers to single use disposable medical and pharmaceutical devices that require cleanliness, precision, and cost- all factors in a fully integrated automation system.
Entirely disposable upstream processes that can support commercial-scale production are a reality and companies are beginning to create more cost effective, single use, modular facilities. Companies are also modifying their infrastructure to support disposables instead of designing all new facilities, by using modular skid based or disposable approaches.Pharma iQ did a study to see how many companies will be retrofitting their existing facilities and 46% of them expect to see a 100% disposable facility in operation by 2018!
In 2010 Shire finished it’s Lexington, MA fully disposable bioprocessing facility. They took advantage of the many benefits associated with this type of facility, including reduced capital investment in facility and equipment, faster campaign turn around time, eliminated cleaning requirements, reduced time to get facility up and running and decreased the risk of product contamination. These savings make a fully disposable facility well worth while, but there are some items that need to worked out, like integrating all the bioprocessing systems required for GMP production.
Fully SUS bioprocessing facilities will continue to grow and become the norm as downstream equipment is developed and systems, connectivitiy and process design are integrated better. It is forecasted that we will start to see hybrid facilities forming and will transform into fully functional SUS facilities in the near future.