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Due to the sensitive nature of their products, clean room facilities for microelectronic and semiconductor applications require stringent environmental controls. These clean rooms also house extremely precise and expensive equipment such as photolithography, etching, cleaning, doping, and dicing machines. Hence, any deficiencies in the cleanliness specifications can affect the entire production process. Other common issues in microelectronic & semiconductor clean room conception and design are the maximizing of space while also enabling future reconfiguration. For all these reasons, a modular clean room system is often the optimal solution.
Often people have a budgetary price for their cleanroom project without much understanding about their needs. A cleanroom is an investment and can be a real asset to a company’s strategy, therefore the build and design should be well thought through.
Your cell and gene therapy research just made a breakthrough. The FDA has approved your new medical device for production. Your compounding activities are expanding to match your incredible growth. Your semiconductor start-up is taking off. Whatever the motive, cleanroom projects are present in a wide variety of markets across the manufacturing, research and development spectrums.
Cleanroom Validation Life Cycle
Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.
There are basically three different air flow systems in cleanrooms: pressurized plenum, ducted supply and ducted return, and ducted supply and open return. Pressurized plenum essentially means you pump the air into the plenum, push it through the filters and down on into the cleanroom. With a ducted supply and ducted return, you’re doing just that; you’re ducting the air delivered to the cleanroom and you’re ducting the air back out of the cleanroom. This last design is prevalent in a pharmaceutical cleanroom arrangement where you have to control the air. The most efficient from a cost and operational standpoint, is the ducted supply and open return. This involves ducting the air into the cleanroom though you let the air flow into an open return, which is essentially an return air plenum.
If you’re going to build a cleanroom that needs to maintain a specific temperature requirement, but the outside environment around it is at a higher temperature (for example if you’re putting a cleanroom in an open warehouse that has no temperature or humidity control), the cleanroom envelope has to withstand the difference. So you need an R-value in the wall to ensure the heat doesn’t transfer through. You also need a structure that will stop moisture from transferring.
The Initial Plan for Factory Construction
• Type of product, product capacity, and design specification
• Calculation of the cleanroom area
• Consideration on airflow, cleanliness, and cleanroom category
• The arrangement for process equipment
• Classification data collection for process equipment's facility requirement(Include water, electricity, gas)
• Moving lines of the process, relocation, shipping, personnel access arrangements
• The location arrangement, safety and convenience consideration for factory system
• Factories funding and milestone planning
• The investigation on the environment special requirement of the product
• Reserved for future development and expansion
• Environmental Protection Impact Assessment Plan
Getting the specification and design right the first time is very important since HVAC is integrated into a building’s framework, making modifications both time consuming and expensive. Additionally, the design, installation, commissioning, and qualification of cleanroom HVAC systems is one of the top considerations in many industries, particularly for pharmaceutical, biotechnology manufacturing facilities. With these conditions in mind, CAT will develop a custom, compliant system to help maintain each cleanroom’s clean environment by allowing the appropriate volume of clean air to each room at a precise temperature and humidity per your requirements.
A typical cleanroom or aseptic facility design and construction process can be divided into several phases: planning, design, construction, commissioning, and qualification.
On completion of the qualification phase, a submission is prepared and submitted to one or more regulatory agencies for approval. On receipt of approval, the facility enters an operational phase in which product is manufactured for sale and routine quality controls are in place.
There is not a single “right” way to construct an aseptic processing facility or cleanroom, as each should be designed to accommodate the processes and products contained in the cleanroom. There are, however, general principles of design that should be followed in constructing a cleanroom or aseptic processing facility.