All equipment designed to Good Manufacturing Practice standards with full traceability and validation documentation.
Mirror-polished product-contact surfaces per ASME BPE for sterile and hygienic pharmaceutical manufacturing.
Structured deliverables supporting Installation, Operational, and Performance Qualification activities.
Pharmaceutical
Equipment Design
Pharmaceutical manufacturing requires equipment designed to the highest standards of cleanliness, sterility, and documentation. Our engineers design clean-in-place systems, sterile processing vessels, and GMP-grade equipment with full traceability — supporting your validation and regulatory compliance requirements from concept through to commissioning.
Equipment Challenges
in Pharmaceutical
Sterility, cleanability, and GMP documentation create unique equipment design requirements.
Clean-In-Place Systems
CIP systems must achieve validated cleaning across all product-contact surfaces. Our designs ensure complete drainability, no dead legs, spray coverage analysis, and integration with automation systems.
Sterile Processing Vessels
Vessels for sterile manufacturing require mirror-polished surfaces (Ra ≤ 0.4 µm), sanitary connections, validated sterilisation cycles, and containment features for potent compounds.
GMP-Grade Equipment
All equipment must meet Good Manufacturing Practice requirements including material certificates, surface finish specifications, weld inspection records, and full design traceability documentation.
Containment & Cross-Contamination
Potent API handling requires containment solutions — from isolators through split-valve systems. Our designs integrate containment requirements from the earliest design stage.
Our 11-Step
Methodology
A systematic approach adapted for pharmaceutical environments, maintaining GMP compliance throughout.
Initial Consultation
Meet with the customer to define project objectives, operational challenges, and process-specific requirements through structured technical workshops.
We capture detailed process parameters such as operating pressures, temperatures, flow rates, fluid properties, and site constraints. This scoping phase produces a formal requirements specification that aligns all stakeholders on performance targets and project milestones.
Conceptual Design
Develop initial design concepts through feasibility studies, trade-off analyses, and preliminary process flow modelling.
Our engineers produce concept layouts, P&IDs, and high-level equipment sizing to compare competing approaches on cost, thermal efficiency, and footprint. Each concept is scored against weighted criteria so the preferred option is selected with full transparency.
Detailed Engineering Design
Create comprehensive 2D and 3D engineering drawings specifying dimensions, materials, tolerances, and manufacturing processes using industry-standard CAD platforms.
Deliverables include general arrangement drawings, fabrication details, bills of materials, and nozzle schedules. Every design decision is traceable to the requirements specification, ensuring the equipment will perform reliably across its full operating envelope.
Simulation & Analysis
Apply advanced computational techniques including CFD, FEA, and thermal-hydraulic modelling to validate design performance across the full range of operating conditions.
Simulations target critical phenomena such as stress distribution, fatigue life, heat transfer coefficients, and flow-induced vibration. Results are iterated until all safety margins and efficiency targets are met, reducing the need for costly physical rework.
Prototype Development
Build functional prototypes or scaled test rigs to validate design concepts, material compatibility, and manufacturing feasibility before committing to full-scale production.
Prototypes are subjected to controlled test campaigns covering performance, pressure integrity, and wear resistance. The empirical data collected is compared against simulation predictions to close any gaps and de-risk the final design.
Design Review
Conduct structured design reviews with multidisciplinary teams and client stakeholders to challenge assumptions, identify risks, and optimise the design.
Reviews follow a formal gate process covering HAZOP, constructability, and value engineering. Action items are tracked to closure, ensuring every aspect from weld accessibility to maintenance clearance is addressed before sign-off.
Compliance & Standards
Ensure every aspect of the design complies with applicable international codes, safety regulations, and environmental legislation relevant to the operating jurisdiction.
Our compliance engineers verify conformance against ASME, API, PED, ATEX, BSI, and EN standards through detailed code calculations and third-party review coordination. This proactive approach prevents costly non-conformances and accelerates certification timelines.
Documentation
Prepare a comprehensive documentation package including design basis memoranda, technical specifications, certified drawings, and calculation reports.
The package encompasses manufacturing procedure specifications, inspection and test plans, welding procedure qualifications, and quality control protocols. All documents are revision-controlled and delivered in formats ready for fabricator and third-party inspector use.
Design Validation
Perform factory acceptance testing and field validation to verify that equipment meets specified performance, durability, and reliability criteria under real-world conditions.
Tests include hydrostatic pressure trials, performance curve verification, vibration monitoring, and leak detection. Any deviations from design intent are root-caused and corrected, with results formally documented in a validation report.
Feedback & Iteration
Incorporate feedback from testing, validation, and client review to refine geometry, materials, or operating parameters for optimal performance.
Design iterations are tracked through a formal change management process that evaluates each modification for impact on cost, schedule, and compliance. This closed-loop approach ensures continuous improvement while maintaining full traceability of every change.
Finalisation
Finalise the design with formal customer approval, closing out all review actions and confirming every requirement has been verified before release to manufacturing.
The final deliverable set includes approved-for-construction drawings, material requisitions, and a design dossier. A structured handover meeting ensures the fabrication team has complete clarity on intent, tolerances, and quality expectations.
What You
Receive
GMP-compliant engineering deliverables supporting regulatory and validation activities.
Equipment Design Specification
User Requirement Specification (URS) and Functional Design Specification (FDS) formatted for GMP validation activities.
Sanitary Design Package
Detailed drawings specifying surface finishes, weld standards (ASME BPE), connection types, and drainability analysis.
CIP/SIP Design
Complete Clean-In-Place and Sterilise-In-Place system design including spray device selection, circuit routing, and cycle development.
Material Certificates
Full material traceability with EN 10204 3.1 certificates, surface finish measurements, and alloy composition verification.
FAT Protocol
Factory Acceptance Test protocol with detailed test procedures, acceptance criteria, and documentation requirements.
Validation Support Pack
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) support documentation.
Proven Results in
Pharmaceutical
Based on equipment design projects across pharmaceutical, biotech, and API manufacturing facilities.
Pharmaceutical
Equipment FAQ
Common questions from pharmaceutical manufacturers about our equipment design service.
Ready to
Design?
Our pharmaceutical engineers deliver GMP-compliant equipment designs supporting your validation and regulatory requirements.
- Comprehensive engineering design & documentation
- Pharmaceutical-specific CFD & FEA simulation
- Full compliance with ASME, API, BSI & EN standards