Supporting industrial performance and regulatory compliance.
Engineering & Performance
As an engineering specialist in industrial processes in the Life Sciences, SEGULA Technologies combines its Manufacturing 4.0 skills to meet the challenges of operational efficiency in both the pharmaceutical and medical device industries:
- Feasibility study
- Preliminary/Detailed Design
- Commissioning (FAT/SAT)
- EAI, HVAC, Utilities
- Revamping
- Capacity increase/industrial transfer
- Manufacturing process improvement (Lean, 6 Sigma, TRG)
- Maintenance engineering
- Supply Chain Optimisation
Quality & Compliance
GMP compliance is a central element in the life cycle of a Life Sciences product. SEGULA Technologies is involved in Quality Assurance and Quality Control as well as the Qualification of your equipment, facilities, production lines and the Validation of your processes.
- Simplify documentation systems and implement an efficient quality system (QA)
- Deviation/CAPA management
- Optimising Quality Control (QC)
- Qualification/Validation (IQ/OQ/QP)
- Metrology
Design and Validation of Medical Devices
As a product engineering specialist, SEGULA Technologies takes charge of your project throughout its life cycle, from development to certification of your medical device, while optimising your Time to Market.
- Design and conception
- Functional analysis and drafting of specifications
- Design thinking
- Numerical calculation: Product (Structure) or Process (Tooling)
- Mechanical design
- Plastics processing
- V&V test validation
- Quality systems
- GMP training
- Creation and implementation of quality management systems (QMS)
- Process validation: sterilisation, injection, extrusion, cleaning, transport
- System audit: ISO 13485 / 21 CFR part 820
- Industrialisation
- Preliminary Workflow,
- Process FMEA
- Drafting of tooling specifications, maintenance and production instructions.
- Validation of the line’s tools.
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