GENERAL SERVICE PACKAGE
Cleanroom planning (definition of technical specifications, layout, infrastructure and airlock planning)
Engineering & execution of compliance projects (DIN EN ISO 13465, FDA CFR 21, Part 820)
Use during concept study to turnkey execution
Independent planning and implementation of individual packages as Work Package Owner (WPO)
Execution of medical 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 manufacturing processes & optimization
- Development of concept studies
- Determination of production parameters
- Development of concept studies
- Determination of production parameters
Qualification & Validation
- Procurement & commissioning of equipment
- Equipment qualification
- Support for process validations
- Equipment qualification
- Support for process validations
Project Management
- Time and cost control
- Planning of personnel deployment
- Reporting
- Planning of personnel deployment
- Reporting
Quality assurance
- General quality assurance in production
- Elaboration & adaptation of SOPs
- Creation & editing of risk analyses
- Elaboration & adaptation of SOPs
- Creation & editing of risk analyses
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
- Consideration of machine and personnel load for room air conditioning
- Determination of sensors for clean room monitoring
- and much more.
Process and plant engineering
Engineering of plants and production processes
- Preparation of technical specifications
- Preparation of cost estimates and bid comparisons
- Evaluation and selection of the right technology & plant size
- Demand-oriented plant integration and area optimization in layout design
- Interface processing for media supply
- Support in supplier and contract award discussions
- Detailed process and infrastructure engineering 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 the procurement of production equipment
- Preparation of supplier evaluations
- Support for block flow diagrams and process flow diagrams
- Support in the creation and maintenance of equipment lists
- Early involvement in quality-relevant processes
- Preparation of plant qualifications and process validations
- and much more.