Process Engineering according to cGMP & ASM-BPE standard

  • c-GMP Regulations Compliance Review, Audit, & CAPA
  • Feasibility Studies & Conceptual Design Ingénierie détaillée
  • Preliminary Design (Basis of Design, BOD)
  • Design of Sanitary Process / Equipment, Clean Utilities, Bio-Pharmaceutical Systems
  • Detailed Design Engineering
  • Critical Process Parameters specifications
  • Process Risk Analysis Assessment according to P-FMEA & D-FMEA standard  & Mitigation alternatives
  • Sanitary Design, Appropriate Material & Internal Finish Specifications according to ASME-BPE2009
  • Critical Instruments, Equipment spcifications & sizing optimization
  • Facilities & cleanrooms architectural and layout design engineering & flow analysis according to ISO-14644 & c-GMP guidelines:
Design of manufacturing facilities & process equipment by means of Autocad 3D, Revit, BIM, Solid Works involving :
  1. Explosive / flammable compounds according to NFPA, CSA, ATEX St1 @ St3 (APAVE Certification or equivalent)
  2. Biotech Process Design : BSL1 to BSL3 of Biological Containment Level (HCD)
  3. Chemical Containment of HP1 to HP4 (Safe Brige)
  4. Sterile & Injectable Units NHP, SV, HV, Injectables + HP6
  5. Pharmaceutical Systems Design: CIP, SIP, RABS, ISOL, Autoclave, Dedusters, LEV, Continuous Thermal Biological Waste Treatment (ACTINI) & watse neutralization ...
  6. Preventive and Protective Technologies and Barriers against cross-contamination, involving primary and secondary segregations, CE, CT, LEV 
  7. Suitable Layout development to avoid MU, IF, CF, & Functional Analysis & Static & Dynamic of FLOWS of Personnel, RM, PCM, SCM, FG, HP & NHP Waste ...
  8. Clean Utilities: PW, WFI, PCA, VP, Pharmaceutical Gas, Process Vacuum ...
  9. Process equipment and filling machines, secondary & tertiary packaging.
  10. Classification, Layout, Flow, Zoning (A-D, ST1-ST3, HP1-6), Hygroscopicity
  11. Piping systems of Process flow, Cleaning solutions (CIP), SIP, Clean Utilities and Wastes.

Project Management & Validation

  • Project & Engineering Management & Programmation
  • Construction management and Onsite Works Supervision
  • Gestion de des budgets et contrôle de l’échéancier
  • Cost management & schedule control
  • Health & Safety management & impacts assessment
  • Commissioning, Benchmarking, FAT, Start-up, SAT
  • Validation IQ/OQ support & review
  • Standard operating procedure (SOP) writing & cGMP training

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner