Technical resources

Project information for the technical consultation

  1. Application: organism, culture or product; biosafety level, genetic modification status, contamination prevention and containment requirements.
  2. Operating mode: batch, fed-batch, repeated batch, continuous or perfusion.
  3. Scale: target working volume and current working scale.
  4. Product and quality: target biomass, product, spore or CFU value; quality acceptance criteria.
  5. Process: feeding, oxygen, pH and temperature requirements; estimated oxygen uptake rate (OUR) and CO₂ evolution rate (CER), foaming, viscosity/rheology and shear sensitivity.
  6. Gas: gas composition, oxygen enrichment, exhaust gas filtration and emission requirements.
  7. Heat load: heat generation, cooling water inlet temperature and seasonal conditions.
  8. Sterilisation and cleaning: autoclave or steam sterilisation in place (SIP); cleaning in place (CIP) chemicals, water quality, waste, effluent and drainage infrastructure.
  9. Facility: steam, compressed air, cooling water and electrical infrastructure.
  10. Regulation and safety: applicable product regulation (food, feed, fertiliser, biopesticide, cosmetic or pharmaceutical); pressure equipment, ATEX, occupational safety and area classification.
  11. Data: control, monitoring and logging expectations; data format, audit trail, user roles, backup, time synchronisation and operational technology (OT) network security.
  12. 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.