Mono & multi system ADC production

Project description
Planning and execution of a mono & a multi production plant for the production of antibody drug conjugates (ADC). The production must be able to be operated safely in the OEL range ^≤1ng/m3. The two plants are planned in an existing building, whereby the mono plant is to be prioritized, i.e. the multi plant is to be completed while the mono plant is still in operation.

pixon engineering was entrusted with the delivery of the entire project from the basic design onwards as part of an EPCMV contract excluding automation.

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Activities:‍

• Overall project management (CAPEX responsibility)
• Planning and construction management of the demolition and new construction
• Planning and procurement of cleanrooms
• Planning of zone concepts taking into account GMP and safety requirements
• Structural calculations
• Planning and procurement of the main equipment of isolators, safety cabinets (RABS), rotavapors, reactors, Nutros, freeze dryer and vacuum drying oven.
• Planning and execution of the development of the equipment.
• Planning and execution in the areas of HVAC, black and ultra-pure media, as well as sanitary installations
• Control and measurement technology Interface coordination
• Execution of space management and creation of flow charts (with storage of technical specifications in database).
• Planning, coordination and execution of commissioning and qualification

Project Challenge
The very high installation density of the infrastructure required a great deal of planning skill. In addition to the complex process requirements, particular attention was paid to accessibility for maintenance. Due to the highly toxic production, the process (containment) and the entire infrastructure had to be planned in compliance with the OEL range ^≤1ng/m3. In the second stage (multi-plant), the ongoing production of the mono plant poses a further difficulty in not influencing it. Some areas are used by both plants.

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