Hans Eder, Business Development HVAC. Credit: ZETA.

High safety and quality standards are vital criteria in planning and developing production facilities for pharmaceutical companies. Despite this, building services engineering is no less significant, and requests in this field are steadily rising. Heating, ventilation and air-conditioning (HVAC) is a crucial factor in this field, subject to stringent regulations, specifically to cleanrooms.

ZETA has this in mind, expanding its service portfolio to include HVAC and cleanroom design, offered by a unique team of 15 experts.

HVAC and cleanroom design demands

What used to be a specialised field of building services engineering, cleanroom technology has recently become part of process engineering. In the pharmaceutical industry, cleanrooms offer process environments with a low particle and bacterial count.

When designing and developing production facilities for the pharmaceutical industry, the high quality and safety standards of the facility itself are vital, and the demands on building services engineering are uncompromising. This remains true for the design, construction and operation of cleanrooms. The disciplines of process engineering, cleanroom technology and building services engineering must combine their awareness and efficiently handle the interfaces between the contractors involved to guarantee the result-oriented design of the production environment based on process requirements. The pharmaceutical industry focuses mainly on good manufacturing practice (GMP) guidelines with end-to-end documentation.

Ventilation for cleanroom technology

The main aim of cleanrooms in the biopharmaceutical industry is to implement a process environment with a low bacterial count. A shell principle aids in devising the cleanroom to make sure this aim is achieved, with the process-critical zone always planned to be the cleanest. Filters, airlocks and pressure zones are significant safety factors of a cleanroom, placing specific demands on the HVAC system.

As well as controlling the temperature and humidity of cleanrooms, the ventilation systems must also guarantee the level of particle cleanliness required by the corresponding cleanroom class. Air speed and change rates are vital design criteria, and there are respective guidelines for each cleanroom class. High cleanroom classes in the pharmaceutical industry, for example, require 40 to 60 air changes an hour while only 0.5 to 4 hourly air changes are enough to assure proper ventilation for an average office or living room.

Planning of cleanroom zones

Extensive planning of cleanroom zones is fundamental when it comes to constructing biopharmaceutical production facilities. Pressure cascades and flow direction ideas need attention in the layout plan. Fine-tuning process plant engineering when producing the neighbouring cleanroom makes smooth and successful project progress achievable, and it also keeps acquisition and running costs low.

ZETA has many years of project experience in this field; continuing its one-stop-shop philosophy, the company added a new team of 15 HVAC and cleanroom design experts. They carry out all the planning, design and construction of the process systems, as well as plan and design the cleanrooms, including heating, cooling and ventilation systems, to ensure a flawless combination of process system and building services.

Expertise in cleanroom design

HVAC and cleanroom experts joined the team of mathematicians, biotechnologists, automation experts, process engineers, welders, fitters and electricians. In its association with chosen long-term trusted partners, ZETA can draw on the combined know-how of 45 top engineers who cover the full range of building services engineering issues, including the building management system (BMS) and the environmental monitoring systems (EMS). BMS deals with HVAC systems and manages parameters such as cleanroom temperature, relative humidity and differential pressure. EMS is a system for monitoring the critical parameters such as the particle count.

At ZETA, the HVAC team collaborates with the project engineering and project management teams and automation experts, all of which make vitally meaningful contributions to each project phase.

HVAC team for all product phases

In the duration of the feasibility study, ideas are examined for technical feasibility, while all the economic issues and goals are evaluated, and opportunities analysed.

ZETA’s HVAC team offers knowledge for all project phases, from modifying the equipment and building services up to and including the formation of new production facilities in the framework of greenfield projects. The result of this feasibility check analysis is an accurate project plan for the next steps in the project.

Concept design then adds structure to ideas. A flow diagram for the production process is drawn up, and the wanted space established in layout plans and 3D model studies, which also involve personnel and material flows. The layout freeze, for example, the definition of the process architecture, is the moment where supporting systems, including media supply and HVAC, and the building itself, must be determined. In the course of concept design, the HVAC engineers check the reserves or limits of the systems already in place or provide efficient integration of fitting HVAC technology in new plant concepts.

All requirements met by contractors and cleanroom systems are defined in the project planning phase (basic design). Sound space management must be guaranteed from an early stage as the space in suspended ceilings and shafts is typically limited.

Process engineers then proceed with the design of fine details before production can commence. After the project planning phase, the HVAC team hands over the design plan to an execution partner and regulates the plant and assembly planning, and later the implementation in the additional stages of the project. With its teams of HVAC, EMS and BMS experts, ZETA can now draw on extensive planning expertise in one place, helping to prevent critical interfaces and facilitates precise fine-tuning of cleanroom technology and processes.

ZETA is currently a general contractor in two comprehensive and complex projects in Vienna, Austria. In one of these projects, the client is planning a new building and conversion of an existing building to support the production system for an innovative product.

Please see our September press release for more information and how to contact.