HVAC and Cleanroom Design: ZETA is Expanding its Service Portfolio
The highest quality and safety standards are key criteria in the planning and development of production facilities for pharmaceutical and biotech companies. However, building services engineering is no less important and demands in this field have been increasing steadily over the past few years. HVAC (heating, ventilation and air conditioning) is a critical factor in this area and is subject to strict regulations, in particular in cleanrooms. With this in mind, ZETA has expanded its service portfolio to include HVAC and cleanroom design, which will be provided by a new team of 15 highly qualified experts.
Exacting Demands Placed on Design, Production and Documentation
While cleanroom technology used to be a special field of building services engineering, it has recently become part of process engineering. In the pharmaceutical industry, cleanrooms are indispensable for providing process environments with a low bacterial and particle count.
When it comes to planning and developing production facilities for the pharmaceutical and biotech industries, not only the high quality and safety standards of the facility itself are key, but also the demands on building services engineering are rigorous. This is particularly true for the design, construction and operation of cleanrooms. The disciplines of process engineering, cleanroom technology and building services engineering must pool their knowledge and effectively manage the interfaces between the contractors involved to ensure 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 as a Key Element of Cleanroom Technology
The paramount objective of cleanrooms in the biopharmaceutical industry is to provide a process environment with a low bacterial count. A shell principle is used in designing the cleanroom to make sure this goal is achieved, with the process-critical zone always designed to be the cleanest. Air locks, filters and pressure zones are important safety elements of a cleanroom. They place specific demands on the HVAC system. Besides controlling the temperature and humidity of cleanrooms, the ventilation systems also have to ensure the level of particle cleanliness that is required by the respective cleanroom class. Air speed and air change rates are key design criteria, and there are corresponding 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 sufficient to ensure proper ventilation for an average living room or office.
Thoughtful Planning Is of the Essence
Elaborate planning of cleanroom zones is important when it comes to building biopharmaceutical production facilities. Pressure cascades and flow direction concepts need to be considered in the layout plan. Fine-tuning the process plant engineering when designing the surrounding cleanroom makes smooth and successful project progress possible and it also keeps acquisition and running costs to a minimum.
ZETA can draw on many years of project experience in this context and continuing their one-stop-shop philosophy we have added a new team of fifteen HVAC and cleanroom design experts. They not only carry out all the planning, design and construction of the process systems, but also plan and design the cleanrooms including heating, cooling and ventilation systems. This ensures a perfect combination of process system and building services.
Expertise under One Roof
ZETA offers comprehensive expertise from one source: HVAC and cleanroom experts have now joined the team of mathematicians, biotechnologists, automation experts, process engineers, welders, fitters and electricians. In its cooperation with selected 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). The BMS deals with HVAC systems and manages parameters such as cleanroom temperature, relative humidity and differential pressure. The EMS is a qualified system for monitoring the critical parameters such as the particle count. At ZETA, the HVAC team cooperates closely with the project engineering and project management teams and also with the automation experts, each one of them making vitally important contributions to each project phase.
The HVAC Team Is Involved in Each Project Phase
In the course of the feasibility study, ideas are scrutinized for technical feasibility, while all the economic issues and objectives are evaluated and risks and opportunities analyzed. ZETA’s HVAC team provides expertise for all project aspects: from changing the equipment and modifying the building services up to and including the construction of new production facilities in the framework of green field projects. The result of this feasibility check analysis is a precise project plan for the next steps in the project.
Concept design then adds structure to the ideas. A flow diagram for the production process is drawn up, and the required space is defined in layout plans and 3D model studies, which also include personnel and material flows. The layout freeze (i.e. the definition of the process architecture) is the moment where supporting systems, including media supply and HVAC, and consequently the building itself, must be defined. In the course of concept design, the HVAC engineers check the reserves or limits of the current systems or provide efficient integration of suitable HVAC technology in new plant concepts.
All the requirements to be met by contractors and cleanroom systems are defined in the project planning phase (basic design). Sound space management needs to be ensured, from a very early stage, because the space in suspended ceilings and shafts is usually limited.
The process engineers then continue with the design of fine details before construction can begin. After the project planning phase, the HVAC team hands over the design plan to an execution partner and coordinates the plant and assembly planning, and later the implementation in the further stages of the project.
Zeta as a One-Stop-Shop
ZETA is available as a general contractor, with overall project responsibility for quality, cost, time and EHS aspects, to companies in the pharmaceutical and biotech industries. ZETA’s focus is on the process itself, as the core business of the company is the planning, design and automation of process plant and the associated media supply equipment. With its teams of HVAC, EMS and BMS experts, ZETA can now draw on comprehensive planning expertise all under one roof. This helps to prevent critical interfaces and facilitates precise fine-tuning of cleanroom technology and processes.
ZETA is currently involved, as a general contractor, in two comprehensive and complex projects in Vienna, Austria. In one of these projects, the customer is planning a new building and a conversion of an existing building to accommodate the production system for a new product.
- Own team of HVAC experts
- Fast project execution
- Many years of experience
The ZETA Group designs, builds, automates and qualifies plants for aseptic liquid production processes in the biotech and pharmaceutical industries.
The engineering portfolio ranges from concept design for pilot plant and basic engineering, all the way through to detail engineering, automation, installation and commissioning. The interdisciplinary project team, composed of biotech experts, process, mechanical and automation engineers, develop fast-track-projects globally. Process characterization, scaling of processes and process design are the key competences of ZETA – from lab to industrial scale.
Close to the customer ZETA provides innovative solutions along the production process of high value APIs. ZETA workflows are based on long-term experience as well as on scientific approach. Magnetic mixing technology and process-controlled freeze & thaw systems for optimal agent storage and transport complete the ZETA product portfolio.
With its twelve subsidiaries globally and a highly qualified staff of 800 people, ZETA is a world-leading supplier in the industry. Best-in-class consultancy from ZETA brings projects forward towards success quicker. ZETA experts design, build and automate production plants at three European sites and carry out GMP qualification and service support packages throughout the entire life of the equipment.