Cleanroom Design

Cleanroom Basics

Cleanrooms are controlled environments that range from small rooms and large suites to modular purpose-built structures, feeding a comprehensive and complex maze of utilities and serviced equipment. These controlled environments have completely separate systems for heating, ventilation and air conditioning (HVAC), lighting, flooring, and walls. Essentially, cleanrooms work to remove pollutants, particles, and contaminants from outside ambient air and are especially important for pharmaceutical facility and laboratory design.

How Does Cleanroom Design Work?

Different types of cleanroom design require different disciplines to lead the design and layout process. Because cleanrooms have complex mechanical systems and high construction, operating, and energy costs, it is important to perform the cleanroom design at the conceptual stage, in a methodical way. The design phase provides for the installation of the HVAC system, including the cleanroom recirculation air and exhaust systems. This is the major part of the cleanroom architecture and must be designed to provide sufficient clean and conditioned air to the space in order to maintain the cleanroom classification during full operation of the room. As part of our evaluation and design process, we factor in:

Unidirectional airflow specification and qualification

Clean room pressurisation

Air change rates and recovery time in non-unidirectional systems

Clean room configuration for the service and maintenance of process equipment

Validation of building control systems

Real time particle monitoring systems

Retest and requalification frequency

Bio-decontamination by fumigation

High efficiency particulate air (HEPA) filter leak testing

Fundamental Cleanroom Design and Layout Decisions

Clean rooms within the pharmaceutical industry cannot be considered in isolation. The decision to use designated space within a production facility cannot be taken lightly. They are expensive to build and operate, which gives the design team the task of balancing a number of factors.

First, we get clarity about the GMP and standards required for your pharmaceutical facility or laboratory design. Next, we determine your budget and evaluate the specifications that would help define the project budget. This include design of the environment and procuring and installing the equipment to monitor and control the following parameters in cleanrooms:

Contaminants

Relative humidity

Lighting

Micro-organisms and particles

Room pressure

Temperature

Air movement

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