Consulting services
Our consulting services include process optimization, equipment selection, facility layout planning, and integration of complete production lines for aseptic filling and pharmaceutical packaging.
We also provide specialized consulting for Pre-Filled Syringe (PFS) manufacturing, including filling, stoppering, closing, inspection, and packaging systems.
Additionally, we offer Blood Collection Tube (BCT) turnkey project consulting, covering complete manufacturing line planning, process design, equipment selection, facility layout, automation, utility planning, and end-to-end project execution support.
Our team supports clients in developing User Requirement Specifications (URS), ensuring compliance with global regulatory standards, implementing robust contamination control strategies, and providing validation support for successful project implementation.
1. Requirement Analysis
- Understanding customer objectives and production requirements
- Review of User Requirement Specification (URS)
- Gap analysis and feasibility study
2. Process & Concept Development
- Process flow development
- Manufacturing concept finalization
- Technology selection
- Capacity planning
3. Facility & Layout Planning
- Cleanroom and facility layout design
- Material and personnel flow optimization
- Utility planning
- Contamination control strategy
4. Equipment Selection
- Selection of process and packaging equipment
- Automation (PLC/SCADA) recommendations
- Utility and ancillary equipment planning
- Vendor evaluation support
5. Engineering & Documentation
- User Requirement Specification (URS)
- Functional Specification (FS)
- Design Qualification (DQ)
- Process documentations
- Risk Assessment (FMEA)
- Validation Master Plan (VMP)
- Standard Operating Procedures (SOPs)
- Engineering drawings and project documentation
6. Regulatory & Compliance Support
- GMP compliance consulting
- FDA, EU GMP, and Annex 1 guidance
- Data integrity recommendations
- Quality risk management
- Audit and inspection readiness
7. Project Implementation Support
- Project planning and coordination
- Installation and commissioning guidance
- Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) support
- IQ, OQ, and PQ qualification support
8. Training & Technical Support
- Operator and maintenance training
- Process optimization
- Continuous improvement recommendations
- Ongoing technical and regulatory support