M+W Process Industries offers services covering the complete GMP value chain from a single source. We provide you with advice and take responsibility for design of your production system. As a partner with a long track record in the medical devices sector, we have the know-how to consult you in questions of development, registration and production as well as in design and construction of manufacturing areas. When you place your trust in the experience we have in technology, compliance and plant construction, you will derive benefit from a high level of certainty and expertise right from the start.

Your Benefits

• Tailor-made plants
• Cost-optimized production
• High plant availability
• Flexibility
• Environmentally friendly concepts

Consulting Services

• Consultation on all aspects of medical devices and to the GMP environment
• Feasibility studies for process and cleanroom technology, mechanical, electrical, building and architecture
• Concept study
• Benchmarking/site selection
• EU-GMP/FDA consulting
• Specific know-how:
  
  • QM systems
  • DIN EN ISO 13485
  • 21 CFR 820
  • CE labels
  • Support for registration
  • SOP development and execution
  • Mock inspections
  • GMP audits

Design Services

• Design of complete or single trades/disciplines
• Concept design
• Basic design
• Permitting design
• Detail design

You have the option of taking advantage of the entire package or individual services. Our objective is optimum realization of your systems, whether this relates to a conversion job or a turnkey project. Our dedicated team adjusts its role to suit individual circumstances. Quality and efficiency are always a top priority. Our specialists have a profile of interdisciplinary knowledge that ensures optimum information flow between the different installation disciplines. We have proven project management and processing methods and we work together with you in an integrated team. Your project will result in a product with a successful outcome within the defined framework for costs and schedule.

Construction Services

• Coordination of all trades/disciplines
• Project management
• Construction management/construction and
  assembly supervision
• Authority engineering
• Procurement management
• General designer (EPCMV)
• Project execution as general contractor
  
  • Design and build (EPC)
  • Turnkey (type of contract, e.g. GmaxP)

Type of Projects

• Rebuilding/revamping
• Extension
• New construction

Process and product certainty are a major priority. Our projects are designed and realized on the basis of medical devices regulations, standards and internal customer specifications. The requirements of MPG*, EMA, FDA, the Australian TGA or the British MCA are taken into account. M+W Process Industries performs entire qualification services for your processes and equipment. Retrospective qualification also belongs to our range of services.

After the completion of your production facility our specialists will accompany you in the Technical Facility Management M+W Process Industries will guarantee 24 hours customer services.

Qualification and Validation Services

• Qualification (DQ/IQ/OQ/PQ)
• Retrospective qualification
• Risk analyses
• Computer system validation (CSV)
• Cleaning validation
• Support during process validation
• GMP consulting
• GxP consulting

Technical Facility Management Services

• Maintenance/customer services
• Requalification
• Recalibration
• Cleanroom measurements
• Contract management for maintenance services
• Maintenance documentations