Turnkey solution_TekMax-Cleanroom Integrated Turnkey Solutions

Turnkey solution

Dalian TekMax Technology — Cleanroom Solutions

Turnkey solution

Process Design & Production Flow Planning

Focusing on cleanroom process design and production flow planning, we optimize process flows, plan equipment layouts, design piping schemes, and configure process gas systems. By analyzing project conditions, we streamline production lines to achieve reasonable layouts and efficient operations, meeting customer mass production and lean manufacturing requirements.

GMP Facility Planning & Cleanroom Zoning

Based on GMP standards, we carry out facility planning and functional zoning of cleanrooms, completing cleanroom classification, functional area layout, and design of personnel/logistics flow lines according to process requirements. We configure airlocks, buffer zones, and other isolation measures to avoid cross-contamination risks, ensuring compliance with production and validation requirements.

Cleanroom Envelope & Layout Design

We conduct the design of cleanroom envelopes and overall layouts, coordinating the selection of envelope materials, ceilings, doors, windows, and sealing joints. In line with process needs, we complete spatial arrangements, control risks of air leakage and particle generation in cleanrooms, and ensure the integrity and reliability of the clean environment.

HVAC & Clean Air System Design

Responsible for the design of HVAC and clean air systems in clean rooms, including airflow organization, temperature and humidity control, pressure differential gradients, fresh air and exhaust schemes, and filter system configuration. Meet cleanliness level requirements, effectively control particles, temperature, humidity, and pressure differentials, ensuring a stable and compliant workshop environment.

Process Utility & Piping Engineering

Specializing in the planning and piping design of clean room process utility systems, covering the layout and optimization of pipelines for nitrogen, pure water, compressed air, waste gas and liquid, refrigeration, and heating. Strictly adhere to process conditions and cleanliness standards, ensuring stable, clean, and safe medium transport, suitable for the long-term stable operation of production processes.

Electrical & Automatic Control System Design (BMS/EMS) SCADA, MES

Providing electrical support, automatic control systems, building management (BMS), and environmental monitoring system design for clean rooms. Covering power distribution, lighting, automatic control interlocks, real-time monitoring of temperature, humidity, pressure differentials, and cleanliness, achieving intelligent monitoring of the workshop environment, stable operation and maintenance, compliance, and traceability, meeting GMP regular supervision requirements.

Plumbing, Drainage & Fire Safety Design

For the specialized design of the cleanroom's drainage and fire protection systems, including production drainage, workshop fire layout, fire facility configuration, and safety protection plans. Strictly comply with cleanroom standards and fire safety regulations, balancing the clean sealing of the workshop with production safety, ensuring project compliance acceptance and stable operation.

Cleanroom Envelope & Finishing Works

The cleanroom envelope structure and specialized finishing works include the implementation of wall panels, ceilings, clean doors and windows, sealed joints, and flooring systems. Strictly follow cleanroom standards to control air leakage at seams and dust accumulation in corners, ensuring the sealing and dust-proof performance of the clean space, meeting GMP clean environment construction requirements.

HVAC & Clean Air Conditioning System

The cleanroom HVAC and clean air system project includes airflow organization implementation, temperature and humidity control, pressure gradient regulation, fresh air and exhaust, and multi-stage filtration system installation and debugging. Stably control particulate matter, temperature, humidity, and pressure differential indicators to achieve cleanroom grade compliance, meeting GMP environmental operation standards.

Automatic Control & Monitoring System (BMS/EMS)

Implement automatic control of clean rooms, building management systems (BMS), and environmental monitoring system projects, completing the interlocking control of power supply and distribution, equipment interlocking control, as well as real-time collection, monitoring, and data retention of key parameters such as temperature and humidity, pressure difference, and cleanliness. Achieve intelligent management and control of the workshop environment, with traceable operating status, meeting GMP compliance operation and maintenance requirements.

Process & Utility Piping Systems

Implement process and utility piping system projects, covering the installation of medium pipelines such as nitrogen, compressed air, vacuum, pure water, and waste liquid and gas, along with the assembly and debugging of valve groups, gas panels, and terminal components. Strictly follow clean construction standards to ensure the cleanliness, safety, and stability of medium transportation, suitable for long-term operation of production processes.

Electrical Power & Distribution System

Implement clean workshop electrical power and distribution system projects, including power distribution, lighting systems, explosion-proof and clean area dedicated distribution, completing the laying of equipment power supply and distribution, grounding protection, and other construction and debugging. Adapt to clean production conditions, ensuring safe and reliable electricity use, meeting GMP and electrical specification requirements.

Commissioning & Qualification (DQ/IQ/OQ/PQ)

Provide clean project debugging and validation services, covering Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Complete system debugging, document preparation, test execution, and report output, assisting clients in completing GMP validation delivery to meet regulatory compliance requirements.

GMP Validation & Regulatory Compliance Support

Provide full-process GMP validation and compliance technical support, including the preparation of validation plans, implementation of tests, output of validation reports, deviation handling, and assistance in improving the document system. Assist clients in meeting regulatory inspection requirements to ensure the project successfully passes GMP compliance acceptance.

EPC Full-cycle Project Management

Provide clean project EPC full-cycle project management services, coordinating design, procurement, construction, commissioning, and verification at each stage, controlling project schedule, quality, cost, and risk, coordinating multiple resources, and ensuring high-quality project delivery as planned.

Procurement & Quality Management

Carry out project procurement and overall quality management, responsible for equipment and material selection, supplier control, material inspection, and acceptance upon arrival, establishing a project quality control system. Control the quality checkpoints in the supply chain to ensure that all materials and equipment meet cleanliness and GMP standards.

HSE Management (Health, Safety & Environment)

Implement the HSE management system for the project, establish on-site health, safety, and environmental control mechanisms, and carry out operational risk identification, safety control, environmental protection measures, and on-site supervision. Avoid construction safety hazards, fulfill environmental protection requirements, and ensure the safety of personnel, the project, and the environment.