Process engineering

 HBW Solutions firmly believes in developing process designs that are centered around the project user requirements. The final goal is to have a robust, validated manufacturing system that produces reliable product consistently. Each of our design engineers have spent time performing both process start-up and CQV. We are complete believers that until you have been in the field implementing your own designs, you are not a complete design engineer. We have spent years building out a team of trained engineers to provide the right solutions for our clients. 

• Plan Views and Equipment layout
• User Requirements
• Process Schedule Optimization
• Process Flow Diagrams
• P&ID Development
• Process Descriptions
• Utilities Estimates
• Engineering Calculations
• Equipment, Valve, Piping Schedules
• Budgetary Estimates
• Equipment Sizing and Specification
• Skid Design
• General Arrangement Drawings
• Bid Package Development
• Technical Bid Analysis
• Fabrication Oversight
• Vendor Design Reviews
• Process Data Sheets and Equipment Lists
• Process Engineering Calculations
• Relief Device Calculations
• System Hydraulic Modeling
• Process Piping Design

We can help our clients with the qualification of an individual piece of equipment or for an entire facility.

Our experience is in the development, implementation, and execution of:

• Enhanced Detail Design Reviews – Design Qualification (DQ)
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Risk Management Tools
• Commissioning / Qualification / Validation Master Plans
• Project Management Tools (Budgeting, Scheduling, Tracking, Resource Planning)
• Facility / Utility System Commissioning Test Procedures
• Critical Utility System Qualification (IQ/OQ/PQ) Protocols
• Process Equipment and Process System Qualification (IQ/OQ/PQ) Protocols
• Controlled Temperature Units(IQ/OQ/PQ) Protocols
• Process Control Systems(IQ/OQ/PQ) Protocols
• Packaging Lines(IQ/OQ/PQ) Protocols

Our team of experts will prepare the necessary protocols incorporating all critical parameters of the process. Execution will incorporate data analysis and resolve any non-conformances. We can collect and evaluate data to ensure the process consistently operates according to set standards. Our professionals provide effective process validation which contributes to assuring product quality.

Our project execution will include evaluating the process capability of the manufacturing and testing procedures. We work hard to ensure that all regulatory requirements and specifications are met.

HBW will provide your company with results that exceed your expectations.

• Process Validation
• Cleaning Validation
• Computer Validation
• Analytical Method Validation

Our project management skills will ensure all the documentation; written and provided, will meet the standards of international regulators and the Quality Assurance team.

• Client representation
• Subject matter experts
• Standard Operation Procedures (SOPs):
• Batch Records: 
• Validation Protocols & Reports:
• Safety Data Sheets (SDS)
• Technical writing

 HBW Solutions engineers have proven track records in process control with backgrounds in pharmaceutical, food, oil and gas, maritime, water treatment, and power.

We have great leadership with multiple engineers with more than 20 years of experience in power and automation. Our group has experience with automation, power (low, medium, high voltage), networking, IT/OT, and system security.

HBW has experience with most PLC’s including Siemens, Rockwell, Modicon, Emerson, Allen Bradley, Honeywell, GE, and Kongsberg along with multiple DCS systems such as Emerson DeltaV, Zenon, and Siemens PCS7. System Architecture and Network Design.

• Hardware Design Specification
• Functional Design Specification/Software Design Specification
• Software Design and Development
• Software FAT
• I/O Loop Testing and IQ
• Commissioning and IQ
• OQ Testing
• Computer System Validation 
• Working Within a GAMP5 Environment
• Compliance with S88 Standards
• Unit Class Structured Coding
• Integration of Fill/Finish, Packaging, Serialization, Bar Coding
• Significant Optimization of CIP Code and Structure
• Computer Systems Validation

• Uninterruptable and Emergency Supply Specification
• Sustainable Power Supplies (CoGen and Solar)
• Electrical Circuit and Panel Layouts
• GMP Instrument Selection and Design