Case
Study 3 - Detailed
Design
The expansion
of an existing facility by means of the addition of a series of new
therapeutic protein purification suites. The main objective of the
design was to account for the phased expansion of the facility, from
10 kg/yr of a single product in one suite, through to 400kg/yr of two
products in four suites.
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Aims & Objectives
- Minimise
capital & redundancy during expansion
- Minimise
headcount
- Determine
buffer prep and hold requirements
- Provide
data for utility distribution design
- Determine
connectivity / material transfer requirements
- Demonstrate
concept to end-client
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Results
- Detailed
expansion plan:
- Utility
demand profiles for each header
- Buffer
hold and prep vessel requirements
- Minimal
buffer prep & hold redundancy
- Potential
bottlenecks at full production:
- 5%
WFI unavailability
- 90%
WFI still peak utilisation
- Space
restrictions at full production:
- Insufficient
parts washer/autoclave provision
- Utilisation >90%
- Queues >24hr
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