The project, managed by GSK’s project improvement team, called in AK pharmaceuticals to:
- Pass on knowledge of engineering systems capable of achieving the required containment levels
- Perform an assessment of the suitability for each unit operation, including cost and operability
- Recommend final engineering control solutions
- Assist in containment testing
- Perform cost estimation
- Produce specifications and perform pre-procurement services
- Select vendors
The processes evaluated in the project included dispensing, wet granulation, fluid bed drying, milling, sieving, IBC filling and discharging, blending, tablet and capsule filling.
The solutions purchased include a number of technologies:
- Split butterfly
- Continuous liner
- Bag over bag
- Click-ring
- Isolator
- Flexible isolator
- Glove bag
The project has been executed over a two-year period.
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