The creation, modification or expansion of a classified space, whether it is a cleanroom for pharmaceutical manufacturing, a biological containment area for research or an aseptic production area, is a complex and multifaceted project. At the heart of this challenge is engineering, which acts as the fundamental pillar to ensure the success, efficiency and regulatory compliance of the facility.
Join us on this journey through the different phases of engineering, where we will explore how each stage contributes to laying the foundation for an optimal and functional classified space.
Table of Contents
Process Engineering:
Before starting any design, it is essential to thoroughly understand the processes that will be carried out within the classified space.
This initial phase involves a thorough analysis of workflows, critical operations, required equipment and potential risks in order to define and optimize the production process.
This includes:
- Process definition: Process mapping, time and motion study, risk assessment, process flow diagram (PFD) design, equipment sizing and material selection.
- Process optimization: Identification of bottlenecks, reduction of unnecessary movements, minimization of cross-contamination risk and simulation of different scenarios to find the optimal configuration.
2. Conceptual Design:
With a thorough understanding of the production process, the engineering team develops a conceptual design that defines the layout of the space, the flow of people and materials, and the basic requirements for air conditioning, ventilation, filtration, electricity, water and gas systems.
In this stage, different alternatives are evaluated and the most suitable option is selected in terms of functionality, efficiency and regulatory compliance.
The conceptual design includes:
- Space distribution: Define the location of the different areas, such as production areas, laboratories, warehouses, changing rooms, etc.
- Flows of people and materials: Establish logical and efficient routes for the movement of people and materials, minimizing the risk of cross-contamination.
- Pre-dimensioning of installations: Estimate needs for air conditioning, ventilation, filtration, electricity, water, gases, etc.
- Cost and schedule estimation: To make a first approximation of the construction costs and project execution schedule.
3. Basic Engineering:
Basic engineering develops the conceptual design and translates it into concrete technical solutions.
In this phase, the main systems of the installation are defined, equipment and materials are selected, and the necessary calculations and dimensioning are carried out.
Basic engineering includes:
- Sanitary architecture design: Layout definition, selection of sandwich panels, roofs, anchorages and finishes, doors, viewers, protections, location of transfer equipment, accesses, exits, etc.
- HVAC system design: Sizing and selection of air conditioning, ventilation and filtration equipment to guarantee the required environmental conditions (temperature, humidity, differential pressure, number of air renewals, etc.).
- Design of electrical systems: definition of electrical infrastructure, lighting systems, power distribution, emergency systems, etc.
- Control systems design: Design of control and monitoring systems to ensure compliance with critical process parameters and environmental conditions.
4. Detail Engineering:
Detailed engineering goes deeper into the design of each system and component of the facility.
In this phase, detailed drawings and technical specifications are prepared, suppliers are selected and the necessary documents are prepared for the bidding and contracting of the works.
Detailed engineering includes:
- 3D model (REVIT): Creation of a detailed three-dimensional model of the installation.
- Construction details: Detailed specifications of construction elements, such as joints, anchorages, finishes, etc.
- Technical specifications: Detailed description of equipment, materials, control systems, etc.
- Measurements: Calculation of quantities of materials and equipment required for construction.
- Specifications: Document that establishes the technical and administrative conditions for the contracting and execution of the works.
The Importance of a comprehensive view of the engineering project
Comprehensive engineering is the foundation on which a successful classified space is built.
Each phase of engineering, from initial analysis through detailed design, helps ensure that the facility meets your goals for quality, safety, efficiency and regulatory compliance.
An experienced, multidisciplinary engineering team is able to address all aspects of the project, from conceptual design to commissioning, ensuring seamless integration of all processes, systems and components.
By investing in solid, rigorous engineering, you are laying the groundwork for a classified space that will not only meet your expectations, but also provide you with a competitive advantage in your industry.
At Iguña Pharma, we have been transforming ideas into high-performance classified spaces for more than 20 years.
Our multidisciplinary team of experts, our passion for innovation and our unwavering commitment to quality make us the ideal partner for your project.
Rely on us for:
- Design customized solutions: Adapted to your specific processes and needs.
- Optimize efficiency: Maximize the performance of your installation and reduce operating costs.
- Ensure regulatory compliance: Comply with the highest quality and safety standards.
- Accompany you at every stage: from conceptual design to start-up and maintenance.
Are you ready to build the future of your business?
Contact us today and find out how Iguña Pharma can take your project to the next level!
