Clean Rooms are workplaces where contamination is controlled. The Clean Rooms are said to provide a conducive environment (for research, development and manufacturing of equipment or processes) with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.
A clean room is a controlled work area that maintains a specified level of air particulates and other contaminants. Clean rooms are common in many industries, such as pharmaceuticals, medical device manufacturing, scientific research, chemical processing, and electronics manufacturing. Clean room design requires careful consideration of its intended use, permissible particle concentration, location, manufacturing process, and cost. The design and specification of a clean room require close coordination between the design team and all of the departments or parties that will use the room.
In most large-scale FDA-regulated pharmaceutical manufacturing operations, it is required that the product be manufactured in a clean room classified between Class 100 and Class 100,000. In an operation where medical tubing is being extruded, the classification would likely be Class 100,000. In a process where inject-able drugs are being manufactured, the classification would most likely be Class 100 or Class 1000.
Cleanrooms and their controlled environments have long been associated with the pharmaceutical and medical industries, but thousands of jobs in cleanrooms have been created in other industries where practitioners perform some amazing applications and experiments within the cleanroom setting. Because the cleanroom can be designed to precision specifications and may operate in accordance with strict industry practices, their clean environment lends itself to many manufacturing pursuits that depend upon its enhanced quality controls. The following are just a few of the amazing applications that cleanroom technology fosters.
Clean rooms are “created” when clean room designers like Vernick & Associates bring together engineering design, fabrication, finish, and operational controls to convert a “normal” room to a “clean room” so that they can be used for manufacturing. These clean rooms must meet the requirements defined in the Sterile Code of Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidance as required by local health authorities.
In this article you are guided through the steps of building a clean room. It is based on our experience with our first DIY clean room in the Mediamatic Bank location. It was part of the "Mushroom Paradise" exhibition. Next we started designing and building our inflatable clean room. This article still gives relevant basic info on clean room construction.
Recently, many industries from pharmaceutical, biotechnology, medical device, hospital pharmacies and medical disposables have clean room operations of differing sizes and complexities. Clients in these industries have recognized that there is a regulatory compliance to demonstrate clean room performance and controlled product bioburden with monitoring the environmental conditions in their aseptic manufacturing areas.
Cleanrooms in healthcare and pharmaceutical facilities must be kept in a state of microbiological control. This article outlines eight key steps for keeping a cleanroom clean.
Imagine if the medication we ingest and the electronic components we use were produced in rooms populated with chemical vapors, dust, and airborne particulates. These impurities would settle on capsules and circuits and contaminate them. Instead, manufacturers create a controlled environment a cleanroom to limit exposure to contaminants.
While not always sterile, a cleanroom follows accepted standards for maximum particulates per cubic meter. Air is filtered in and recirculated through HEPA air filters. Equipment is designed to generate minimal air impurities. Employees wear gloves, face masks, and head covers. Often, donning jumpsuits or smocks is also necessary. The room is cleaned daily, sometimes every few hours, according to rigorous quality procedures.
With an increasing emphasis on maximizing product yield, improving quality control and ensuring safety, companies throughout many industries are looking to install clean rooms and controlled environments in their facilities.
Whether you need to build a Class 1 environment for nano-technology research, or a temperature- controlled enclosure to protect delicate machinery or processes, PortaFab has over 35 years of modular clean room design and construction expertise. Featuring a complete line of modular systems and interchangeable components, we can offer a custom solution for your cleanroom application.
The following presents a brief overview of how clean rooms are classified, as well as some design considerations for perfecting your clean room project. For in-depth information on designs pertaining to pharmaceutical cleanrooms, review our bio-pharmaceutical cleanroom design guidelines, as well as other helpful articles in our cleanroom learning center.
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