RANGE OF SERVICES
Cleanroom planning (definition of technical specifications, layout, infrastructure and airlock planning)
Engineering & execution of GMP compliance projects
Use during concept study to turnkey execution
Independent planning and implementation of individual packages as Work Package Owner (WPO)
Execution of (bio-)pharmaceutical and medical technology process engineering from design to project handover to the customer
Support and cooperation during commissioning, qualification & process validation
Optional, support of project management: from the offer (scope definition, cost calculations, staffing) to project execution (reporting) to project handover to the customer
RANGE OF SERVICES
Cleanroom planning
- Layout design
- Planning of material and personnel locks
- Determination of technical clean room specifications
- Planning of material and personnel locks
- Determination of technical clean room specifications
Process engineering
- Development of production processes
- Development of concept studies
- Determination of production parameters
- Development of concept studies
- Determination of production parameters
Plants & Apparatus
- Process planning
- Procurement of equipments
- Support during commissioning of plants
- Procurement of equipments
- Support during commissioning of plants
Project Management
- Time and cost control
- Planning of personnel deployment
- Reporting
- Planning of personnel deployment
- Reporting
Engineering
- Preparation of technical documentations
- Elaboration of SOPs for the operation of plants
- Preparation of risk assessments
- Elaboration of SOPs for the operation of plants
- Preparation of risk assessments
Infrastructure
- Consideration of secondary areas
- Planning according to demand
- Inclusion of utility plants
- Planning according to demand
- Inclusion of utility plants
MAIN DISCIPLINES
Cleanroom planning
Planning an environment suitable for a cleanroom
- Preparation of technical specifications
- Clean room compatible plant integration
- Elaboration of lock procedures according to current standards
- Preparation of cost estimates with the help of mass extracts
- Determination of production processes through layout design
- Air conditioning with consideration of machine and personnel loads
- Support for online cleanroom monitoring
- and much more.
Process and plant engineering
Planning of processes and procurement of equipment
- Preparation of technical specifications
- Preparation of cost estimates and bid comparisons
- Evaluation and selection of the right technology & plant size
- Area optimization in layout design
- Interface processing for media supply
- Support in supplier and contract award discussions
- Detailed process planning through the development of typicals
- and much more.
Engineering
Preparation of technical documentation
- Preparation of technological-technical as well as organizational-administrative documentation
- Support for computer-aided 2D/3D planning
- Creations of drawings
- Support for block flow diagrams and process flow diagrams
- Support in the creation and maintenance of equipment lists
- Determination of material and energy quantities
- Development of main and auxiliary production processes
- and much more.