Qualification & Engineering

Your reliable partner for Qualification, Concept Development and Commissioning Activities

Qualification & Commissioning

Our service excellence is achieved through an interdisciplinary teamwork among engineers and technicians, who have a unique integrated knowledge in process engineering, information technology and quality in regulated environments. Due to our complete in house instruments park and our expertise in Pharmaceutical, Biopharmaceutical and APIs field, we can provide turnkey qualification solutions for process equipment and utilities qualification, based on the latest technologies and regulatory requirements. This allows us to focus on minimizing compliance related risks and costs for our clients.

Pharma Capabilities
  • Qualification Protocols Writing and Execution
  • Installation, Operational and Performance Qualification
  • Validation Master Plan
  • Commissioning Plan
  • Cleaning Validation
  • Process Validation
  • Media Fill Protocols
  • Calibration services
  • Witnessing of Supplier Testing Activities (FAT/SAT support)
  • Inventory of Process Equipment and Utilities
  • Quality Risk Management
  • User Requirement Specifications
  • Technology Transfer
  • Process Analytical Technology (PAT) Support
  • Clean Room Qualification
  • Temperature Mapping Services
  • Transport Validation
Medical Devices Capabilities
  • Process Validation
  • Qualification Protocols (IQ / QQ / PQ)
  • Validation Master Plan
  • Commissioning Plan
  • Cleaning Validation
  • Witnessing of Supplier Testing activities (FAT/SAT support)
  • Inventory of Process Equipment and Utilities
  • Process Risk Analysis
  • User Requirement Specifications
  • Technology Transfer
  • Temperature Mapping Services
  • Transportation Validation
  • Validation of Sterilization Processes (ETO, Gamma, Beta, Steam, Overheated water)

We have developed a deep knowledge in the validation of the following systems:

  • Molding Injection molding and blow molding
  • Extrusion
  • Automated Assembling
  • Gluing
  • Infrared and Ultrasonic welding
  • Granules Manufacturing & Handling Systems
  • Dialysis cartridges assembling lines
  • Annealing Ovens Systems
  • Steam and Overheated Water Autoclaves
  • Eto Autoclaves
  • Beta & Gamma Sterilization Systems

Facility Engineering

There are many steps in the design of a medical device facility. In PQE’s approach and solutions, we emphasize delivery based on our three key project principles: TIME-COST-QUALITY. Our goal is to establish a partnership with our clients in order to create cost- and business- effective engineering solutions for Pharmaceutical, Biopharmaceutical, APIs and MD facilities to ensure that related national and international regulatory requirements are met. Due to our focus on Life Science, we always assess and design with the latest standards and with the point of view of the end users.

Pharma Capabilities
  • Concept Development for Manufacturing Facilities and Laboratories
  • Support for Basic & Detail Design Support
  • Technology Transfer Support
  • Commissioning Support
  • GMP Review
  • Design Qualification
  • Construction Supervision
  • Project Management
  • Visual Factory Programs
  • Risk-Based Process Equipment & Utilities Maintenance Plans
  • Value Stream Mapping
  • Overall Equipment Efficiency (OEE)
  • De-Bottlenecking and No Added Value time reduction programs
  • Cost-Effectiveness optimization with Operational Excellence Programs
  • Lean-Production programs
  • Procurement Support
Medical Devices Capabilities
  • Concept Development
  • Support for Basic & Detail Design
  • Technology Transfer Support
  • Commissioning Support
  • GMP Review
  • Construction Supervision
  • Value Stream Mapping
  • Project Management
  • Visual Factory Programs
  • Procurement Support