Our Services
Flexible in our thinking, pragmatic in our implementation - for solutions that suit you.
We work with handshake quality.
We support you with your projects.
Project management
Planning, coordination and monitoring of all phases of a project, from concept development, procurement and construction through to commissioning of the plant. The focus here is on compliance with regulatory requirements, quality standards and deadlines while monitoring ongoing project costs.
- Project Management and-coordination (with agile PM like KANBAN, Sprint, etc.)
- Tendering
- Authority Engineering
- Cost estimates
- Scheduling (for process related crafts)
- Procurement and -strategies
- Project controlling
- Change & Claim Management
- Cause and effect analysis (e.g. ISHIKAWA, Root Cause Analysis, 5 Why, FMEA, etc.)
Process Engineering
Development, optimization and implementation of production processes for the manufacture of pharmaceutical products.
- Equipment specifications (z.B. Utilities, Reinstmediensysteme, Behälter, Pumpen, Wärmetauscher, etc.)
- Designing of pipe systems (e.g. loop systems, pressure loss calculations, chemical dosing systems, etc.)
- Development of flow diagrams (e.g. block flow diagrams, process flow diagrams, PIDs)
- Risk analysis (HAZOP, GMP)
- Energy and mass balances
- Process simulations and optimizations
- Heat recovery systems
- Plant design with considerations regarding ex-zoning and containment handling
- Planning, monitoring and executing commissioning phases
- Engineering Management with cross-trade interface coordination
- Handling of package units (e.g. clean media generators, aseptic filling lines, autoclaves, GMP parts washer, etc.)
- Quick conceptual design studies with cost estimations
3D design and modelling
Visualization of the system and its design to determine and optimize it before construction begins. It enables a realistic representation of the arrangement of devices, pipelines and other components in order to avoid collisions and make the construction process efficient.
- Creating 2D layouts and 3D positioning
- Space Management and-coordination
- 3D piping, support planning and skid design
- Creating mounting systems and pipe racks
- Interface coordination of cross-craft and managing overall model
- Clash check and resolving
- Steel construction planning and equipment modelling
- Creating manufacturing documents (isometrics drawings, MTOs, steel construction drawings)
- Simulation of construction processes - BIM Management
- Animation of process flows in 3D
- 3D Laserscan
- 3D printing
Qualification Engineering
Ensuring GxP compliant design, execution and qualification of plant engineering, process and clean room facilities in the pharmaceutical and life science industry.
- Qualification planning and documentation: Creation of comprehensive qualification plans, including documentation of qualification documentation
- Performing Risk analysis , e.g. FMEA or Risk Assesments
- Commissioning support, management and supervision of commissioning activities
- Regulatory consutling,Consulting on regulatory issues relevant to GxP compliance
- Creation and maintenance of GMP-compliant documentation (URS, functional descriptions, SOPs, etc.)
- Support with quality improvements and corrective measures for Deviation reports, change controls (change management) and CAPA-Management
- Process validation, cleaning validation, re-qualification and regular reviews to ensure compliance with GMP standards
- Continuous optimization of processes, equipment, and documentation in the GMP environment
Field of applications, e.g., wie beispielsweise:
- Pharmaceutical (ultra-pure) media systems
- Process equipment and package units (containers, panels, washing machines, hot air and steam sterilizers)
- Aseptic fill & finish
- Packaging
- COTS (Commercial off the Shelf Equipment)
- Clean room, containment, HVAC
Construction Management
Planning, managing and monitoring the construction phase to ensure that the project is completed on time, within budget and to quality and safety standards.
This requires the coordination of all parties involved, including construction companies, suppliers and engineers, as well as compliance with legal and regulatory requirements.
- Construction process planning
- Move-in studies
- Hook-up planning
- Coordination of execution crafts
- Monitoring construction progress Baufortschritt
- Lock out, tag out safety concepts
DELTA-NEX counts on modern software
Utilizing modern software is crucial to us.
Here some examples.
Inhouse Training
Do you have a new project (EPCM, conversion or new equipment) and your team needs more engineering or project management expertise to get started?
We would also be happy to come to you and conduct in-house training with your project team.
We offer training in the following areas. Both on-site and online.
- Creation, reading and understanding of schematic drawings (e.g. process flow diagrams, PIDs, etc.).
- Equipments: overview, pros & cons, dimensioning, project execution, etc.
- Clean Utilities
- Most relevant calculations (media consumption, pressure loss, loop design, etc.)
- Using modern software 3D planning software
- Skid planning
- LOTO and safety concepts
- Creating assembly plans
- Schulungen von Mitarbeitern zu GMP‑relevanten Abläufen und technischen Standards
DELTA-NEX collaborates with a cross-craft network of partners zusammen, for finding the most suitable solution for you - even if we cannot offer all services on our own.
