Process & Mechanical
Process & Mechanical Engineering Capabilities
As a multi-discipline engineering consultancy operating in highly regulated industries, Synertec has comprehensive expertise in process and mechanical engineering. We provide engineering services across the entire project lifecycle, making us a one-stop solution for all engineering needs. Services include FEED Studies and concept development, detailed design, procurement, validation and testing, commissioning.
We collaborate closely with clients to develop a clear understanding of their objectives and evaluate potential solutions. This stage is crucial for laying the groundwork for a successful project. Synertec can help develop bench-scale projects and pilot plants and scale up to full manufacturing facilities. We can also assist with optimization and improvement of existing processes and can provide specialised consulting services around process hazards, risk and compliance.
Detailed design is performed with our team of specialist engineers alongside our design and drafting team. Capable of providing full turn key systems, Synertec can provide all procurement services, and manage project build, through our network of fabricators and installers.
Synertec expertise includes, Good Manufacturing Practice (GMP) and clean rooms, storage and handling of dangerous goods, Hazardous Areas, and a wide range of industrial and manufacturing processes
Typical process and mechanical design deliverables and services include:
HAZOP and Risk Studies | Control Strategy and Functional Specification | Piping Design and Pipe Stress Analysis | Process and Instrument Diagrams |
Hazardous Area Design and Documentation | Equipment Datasheets and Specifications | 3D Modelling | Modelling and Optimisation |
Dangerous Goods Compliance | Equipment Schedules | GMP and Facility Design, HACCP Assessments | Compliance to Australian and International Standards |
Process Design and Specification | Heat and Materials Balances | Site and Process Layouts | Tender Documentation |
Industries served:
- Pharmaceutical and Life Sciences
- Food and Beverage
- Future Energy
- Energy: Oil, Gas and Terminals
- Defence
- Water and Wastewater Treatment
- Advanced Manufacturing and Chemicals
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is a system that consists of processes, procedures and documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards. Implementing GMP helps protect both company and consumer from negative medicinal or food safety events.
Synertec specialise in design, construction, commissioning, and validation of GMP critical facilities, in particular pharmaceutical manufacturing operations. Synertec personnel have a wide range of skills and expertise that encompass engineering, quality assurance, construction, and manufacturing.
Our expertise includes Hazard Analysis Critical Control Point (HACCP) assessments, and High containment environments, such as Physical Containment (PC), Quarantine Containment (QC), and Bio Containment (BC).
Digital Engineering
Synertec’s design office – digital engineering team utilise a range of Computer Aided Design (CAD) packages including AutoCAD and Plant3D. We work in both two-dimensional and three-dimensional design environments, depending on client and project requirements.
Our drafting practices comply with ISO 9001 and out use of and reference library of drafting standards governed by applicable drafting document control software ensures a three-tier review process prior to drawing release. We have intelligent drafting tools to create smart Piping and Instrumentation Diagrams (P&IDs), which link the P&ID to 3D model.
In conjunction with Plant3D, we use Elecdes for electrical and instrumentation design. This ensures consistency between the P&ID, the 3D model, and the electrical/instrumentation database, allowing documentation such as instrument schedules, loop diagrams, line lists equipment lists, and a bill of materials to be extracted from a single database.
Relevant Experience
Synertec’s designers are experienced with various design packages including:
- Plant 3D
- Elecdes
- Autodesk Electrical
- Revit
- Navisworks
Facility Design Capabilities
Synertec’s process and mechanical engineers are experts in facility design, particularly of pharmaceutical facilities and clean rooms. Synertec has a team of process and mechanical engineers experienced in all phases of facility design from concept design through to commissioning and validation.
Our team works with our clients to understand facility requirements including process services, control systems, regulations, and compliance. Supported by an in-house design and drafting team, Synertec engineers fully document the facility design, including tender documentation for subcontractors and equipment suppliers and production of for-construction drawings for the facility build.
Our process and mechanical engineers are well supported by our automation and electrical teams to ensure all elements of the facility, including control systems, are incorporated in the design.
Our range of services is extensive, including the following:
- Process piping and tank design
- Facility layout, schematics, and architectural details
- Instrumentation and control system design, including safety control systems
- Process heating, ventilation, and air-conditioning, and heating / cooling system design
- Hazardous Area Classification reports for all areas of a building
- Advice on building requirements and constraints to support the architect and consulting engineers
- Piping and instrumentation design (P&ID) for the manufacturing and storage processes
- 3D modelling
- Pipe stress analysis and flexibility assessments of piping systems
- Specifications for pipes, valves, pumps, electrical equipment, etc. for all processes and services
- Tender documentation
- Risk management, change management, safety in design, Failure Mode and Effects Analysis (FMEA) and Hazard and Operability (HAZOP) studies
- Pricing estimates for facility construction
- Negotiations with statutory bodies and approval authorities such as the Environment Protection Authority (EPA), United States Food and Drug Administration (FDA), Australian Therapeutic Goods Administration (TGA), and more
- Coordination of town planning permits and building surveyor signoff
Relevant Experience
The facility design experience of Synertec’s engineering team includes work for the following clients:
- CSIRO
- CSL
- Ego Pharmaceuticals
- Medical Development International
- Merck Sharpe and Dohme
- Pfizer
Process Safety and Risk Assessment
Synertec has considerable experience with Dangerous Goods compliance, HAZOD, HAZOPs, CHAZOPs, LOPAs and Risk Assessments in all stages of projects. The expertise built into our usual engineering practices and can be offered as a standalone service. Synertec also have in-house TUV certified Functional Safety engineers and can ensure that processes safety is fully integrated into automatic and instrumentation systems.
Clean Room Capabilities
Synertec’s process and mechanical engineers are experts in facility design, particularly in pharmaceutical projects and clean rooms. Synertec has a strong, diverse team of process and mechanical engineers experienced in all phases of clean room design, from concept through to commissioning and validation.
Our team works with clients to understand the clean room requirements, from process services through to control systems, regulations, and compliance. Supported by an in-house design and drafting team, Synertec engineers can fully document the design of the clean rooms including tender documentation for all subcontractors and equipment suppliers, and construction drawings for the build.
The process and mechanical teams are strongly supported by the automation and electrical teams to ensure all elements of the clean room, including control systems, are incorporated in the design.
Core Capabilities
- Process piping and tank design
- Facility layout and schematics
- Instrumentation, safety, and control system design
- Process Heating, Ventilation, and Air-Conditioning (HVAC) systems
- Design of heating and cooling systems
- Fire systems design
- Hazardous area classification
- Advice on building requirements and constraints
- Develop piping and instrumentation diagrams for manufacturing and storage processes
- 3D modelling
- Specifications for pipes, valves, pumps, electrical equipment, etc.
- Tender documentation
- Risk management, change management, and safety in design
- Failure Mode and Effects Analysis (FMEA)
- Hazard and Operability (HAZOP) studies
- Pricing estimates for construction
- Negotiations with statutory bodies such as the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Environmental Protection Authority (EPA) and more
- Coordination of town planning and building surveyor signoff
Focussed on Outcomes
As a team of specialist engineers, Synertec has an unwavering focus on solutions and outcomes. We recognise the importance of good design of clean rooms and understand the impact that poor design can have on operations and quality.
Consistency, safety, quality, and reliability are vital elements of clean room design and our focus on outcomes drives success on those key elements.
A recent example of a successful project outcome is Synertec’s work for Medical Developments International and the CSIRO on their manufacturing facility for inhaled pharmaceuticals. Compliance of the clean rooms was certified to meet the requirements of the TGA and the FDA, resulting in a successful FDA Audit and the issue of a license to sell product into the US market.
Relevant Experience
- Key clients: CSIRO, CSL, Ego Pharmaceuticals, Medical Developments International, Merck Sharpe and Dohme, Pfizer
- Biological Vaccines Manufacturing Facility: A suite for the manufacture of conjugated vaccines to meet FDA compliance and approval, with full High Efficiency Particulate Air (HEPA) filtration and containment zones
- Manufacturing facility for inhaled pharmaceuticals: Working with CSIRO and Medical Developments International for design, project management, construction supervision, and validation
- Bacterial fermentation facility: Upgrade of a facility manufacturing viral and bacterial vaccines for the animal sector
- Cytotoxic drug facility: Facility design for Pfizer’s Leap Frog facility in Melbourne specialising in cytotoxic drug products
