SPOC - The Single Point of Contact
according to the highest GMP standards of the pharmaceutical, biotechnological, chemical and food industries, such as:
- Engineering, design and production of a complete system
- EN ISO 9001
- ISO 3834-2
- EN ISO 14001
- EN ISO 1090 EX3
- GMP
- Integrated CIP / SIP
- Complete automation
- System compliant with CFR part 11
Field of Expertise
- Project development. Basic design consultation.
- Process development and consultation.
- Detailed design - P&ID development.
- 3D modelling.
- Technical specifications.
- Process calculation (heat transfer, pressure, flow).
- Software calculation and design of pressure vessels.
- Structural design & FEM analysis
- Project management.
- Execution: production, inspection & testing, assembly, automation
- Qualification
- Validation support
- Maintenance support
PHARMACEUTICAL AND BIOTECH
Design and production of process systems:
- PW, water purification systems
- WFI, water for injection systems
- PS, clean vapor systems
- SOLVENTS, solvent systems
- Washing systems
- PROCESS GAS SYSTEMS: Compressed air, Nitrogen system.
Project documentation
- TECHNICAL DOCUMENTATION – P&ID, equipment list, process description, technical drawings, 3D model, layout
- Hardware specifications
- Software specifications
- Design qualifications
- Project quality plan
- Qualification plan
- Sequence matrix
- Functional specification
- List of signals
- Wiring diagrams
- Risk analysis
- Certificates of materials in contact with the Product
- CE mark
- BUILT-IN Equipment instructions and manuals
- Welding documentation
- Calculators of measuring instruments
- PRODUCT quality control reports (pressure test, NDT test, roughness test, etc.)
- Passivation documentation
- Working instructions, system maintenance recommendation, spare parts
- ATEX documentation
- Installation qualification documentation
- Documentation of operations qualification
