Engineering and Technical Services
Our engineering and technical services include support in the development and manufacturing of products, processes, and/or components from conception, design, and scale-up to manufacturing.
Our engineering consultants are top experts in the implementation of FDA requirements, quality assurance measures, and current Good Manufacturing Practices that are standard operation in client facilities. From start to finish, our highest standards adhere to product safety. All the while, the utmost importance is given to personnel and environmental safety and is practiced regularly.
“We’re a results driven company that implements personalized solutions to achieve a positive impact on quality and operating performance in Life Sciences for the mutual benefit of patients and the industry.”
Areas
Aseptic Processing
- RABS / Isolators
- Clean Rooms
Upstream and Downstream Manufacturing
- Cell Culture
- Fermentation
- Harvest
- Media Systems
Downstream Manufacturing
- Purification
- Filtration
Fill and Finish
- Filling
- Lyophilization
- Packaging: Serialization
Technical Knowledge
- Production Systems
- Product Development
- Facilities and Equipment
- Information Systems
- Supply Chain Management
- Quality Systems
- Regulatory Compliance
- P&IDs and PFDs
- Evaluation, Inspection, Maintenance, Design, Analysis, and Improvement of Various Equipment, either Electrical or Mechanical
- Performance of Extensive and Complex Repairs on Existing Equipment
- Equipment Procurement and Specification Development
Leadership and Professionalism
- Demonstrate cost effective, risk-based approach
- Practice time-management
- Collaborator with various roles and disciplines, both internal and external
- Excellent written and verbal communication skills
Engineering Support
- Facilities Startup
- Equipment Shakedown
- Utility Piping Walkdown
- Process Optimization
- Controls Testing, including DeltaV, PLC and more
- Aseptic Processing
- Equipment Selection & Scale-up
Commissioning & Qualification
- Leveraging Commissioning into Qualification Plan (ASTM E2500-13)
- New Facility / Expansion
- Aseptic / Sterile Processing and Clean Room
- USP Grade Water systems, including WFI and more
- Compressed Gases, i.e., Clean Air, Nitrogen
- New Equipment