Project preparation guide
System volume and scope are defined from application, operating mode, scale, process, utility and validation information. Not every parameter needs to be settled for the first technical meeting.
Project information for the technical consultation
- Application: organism, culture or product; biosafety level, genetic modification status, contamination prevention and containment requirements.
- Operating mode: batch, fed-batch, repeated batch, continuous or perfusion.
- Scale: target working volume and current working scale.
- Product and quality: target biomass, product, spore or CFU value; quality acceptance criteria.
- Process: feeding, oxygen, pH and temperature requirements; estimated oxygen uptake rate (OUR) and CO₂ evolution rate (CER), foaming, viscosity/rheology and shear sensitivity.
- Gas: gas composition, oxygen enrichment, exhaust gas filtration and emission requirements.
- Heat load: heat generation, cooling water inlet temperature and seasonal conditions.
- Sterilisation and cleaning: autoclave or steam sterilisation in place (SIP); cleaning in place (CIP) chemicals, water quality, waste, effluent and drainage infrastructure.
- Facility: steam, compressed air, cooling water and electrical infrastructure.
- Regulation and safety: applicable product regulation (food, feed, fertiliser, biopesticide, cosmetic or pharmaceutical); pressure equipment, ATEX, occupational safety and area classification.
- Data: control, monitoring and logging expectations; data format, audit trail, user roles, backup, time synchronisation and operational technology (OT) network security.
- Delivery and validation: factory and site acceptance tests (FAT, SAT), design, installation and operational qualification (DQ, IQ, OQ), calibration and material/weld documentation; training and support scope.