The idea of a “cleanroom” may bring to mind a bright white room filled with microscopes and scientists wearing white lab coats working on circuit boards or NASA spaceships. Although those environments still exist, cleanrooms have become much more mainstream and are now used across a wide variety of industries. The reason for this is a contamination-controlled environment is essential to manufacturing processes across the board. Each specific industry usually has a different set of requirements and standards. Let’s look at various industries that use cleanrooms and how each one differs.
Semiconductor/Electronic Manufacturing and Nanotech Cleanrooms
Prevention of contamination and defects is critical in the production of microelectronics and other computer components. Many of these parts have pieces that are not easily viewable by the human eye, meaning that there is no room for error as it may not come to light until it is too late. Cleanrooms used in the electronic and nanotech industries are designed to regulate these factors, carefully monitoring static, pressure, and particulate levels. These environments are usually pressurized with filtered air to eliminate even the smallest particles. Ceilings are often equipped with fan filter units (FFUs) cycling at regular intervals to continuously replace air in the cleanroom. Depending on the level cleanroom, full PPE (personal protective equipment) such as coveralls, gloves, and head protection are commonly used in these environments. Additionally, ESD and Static Control products are also implemented to further reduce the risk of component damage.
Life Sciences and Biotechnology Cleanrooms
The cleanrooms used in the life sciences and biotechnology industries are very similar to the “white room filled with scientists in white coats” concepts. Since these industries work closely with biological components, great care must be taken to ensure that samples and technology are not compromised by the environment. These cleanrooms closely monitor contamination by particulates, and the rooms are built in a coved manner to ensure that every surface is able to be cleaned and sanitized. The people working within these cleanrooms are required to wear special attire that is only worn within the room to avoid bringing in harmful bacterias. Additionally, these cleanrooms are designed to maintain pressure levels and keep cross-contamination at bay using air filters.
Pharmaceutical & Sterile Processing Cleanrooms
Cleanrooms involved in the production and handing of drugs must follow a variety of stringent guidelines. Pharmaceutical cleanrooms are highly regulated environments that require meticulous levels of compliance with various regulations and codes. The FDA sets forth guidelines for these environments in Facilities & Equipment: CGMP Requirements. It states that: Aseptic processing (cleanrooms) are to include, as appropriate:
- Easily cleanable floors, wall, and ceilings of smooth, hard surfaces
- Temperature and humidity controls
- An air supply filtered through high-efficiency particulate air filters (HEPA) under positive pressure, regardless of whether flow is laminar or nonlaminar
Additionally, usp797 and usp 800 requirements must also be adhered to when dealing with the handing and manufacturing of drugs. These chapters focus on the “handling, storage, compounding, dispensing, and administration of hazardous drugs.”
Like those used in the life sciences and biotechnology industries, cleanrooms used in medical settings must maintain high levels of cleanliness to avoid contamination. These cleanrooms are designed with cross-contamination in mind, using surfaces that are easily sanitized and filters to prevent particles from entering the cleanroom. Professionals working in these cleanrooms are also required to wear special garments, such as plastic clothing and shoe covers, gloves, and hairnets to prevent bacteria being brought into the closed environment. Without these safeguards in place, the people who work in these cleanrooms have the potential to infect at-risk medical patients.
Aerospace & Automotive Industry
Not all vehicle components are built on the factory line — at least, not anymore. Vehicles have become more and more technologically advanced, often featuring delicate computer and circuitry pieces. Since these tiny pieces are integral to both a vehicles operation and safety, defects or errors in these parts can result in expensive or dangerous accidents. The need for cleanrooms in the aerospace and automotive industry has grown as a result. Similar to the electronic and nanotech industries, cleanrooms used in the automotive industry are focused on preventing error. These cleanrooms closely control the humidity and temperature, as well as minimizing static, pressure, and particulate levels. Additionally, FOD (Foreign Object Debris) Control is something that is becoming widely adopted in aerospace and automotive production environments.