CleanroomsUSA

Applications for Cleanrooms Part 1

During the COVID-19 scare of 2020, cleanrooms were and are an essential part of the treatment process. Since their inception in 1960, cleanrooms have found use in several industries, including some that may seem a bit unexpected. Below is a description of some of the uses of cleanrooms.

Isolation Rooms for Hospitals

Isolation rooms are a special form of clean room that is designed to separate patients with unique or unusual symptoms away from other people. The requirements for an isolation room are very similar to those for all other forms of clean rooms and may have an ISO rating depending on the function of the room. Patients placed in isolation rooms have specific medical conditions or infections on their skin, in their lungs, or intestines. This special form of clean room prevents the spread of disease and includes patients that get easily infected.

The type of air pressure for an isolation room varies in accordance with the type of illness the patient has. Negative air pressure is used to prevent contaminants from escaping the room. Air is pulled into the room and filtered before it is forced outside. In cases where a patient has a weakened immune system, positive air pressure is used to prevent contagious diseases from entering the room. Positive air pressure pumps air through a set of HEPA filters into the room.

These unique rooms have been designed by the collaboration of healthcare workers and clean room engineers. They have alarms to detect pressure loss, hands free showers and toilets, and no circulating air. They use high efficiency particulate air (HEPA) filters that are designed to remove dust, pollen, mold, bacteria, and any particles that are 0.3 µm.

Semiconductor and Microelectronic

The sensitive and delicate nature of electronics manufacturers' equipment demands very stringent environmental controls. Any defects or deficiencies in a clean room can greatly affect a production run. The clean rooms for these manufacturers are air tight, have UV filtered light, and control mechanisms for electrostatic charges. Unlike most clean rooms, ones for the electronics industry are larger and more spacious.

The integrity of products for the semiconductor and microelectronics’ industry can severely suffer if contaminated with microscopic particles. One minute particle can cause significant problems such as haze on optics, which increases cleaning costs. Clean rooms for semiconductors and microelectronics have to consider every aspect of clean room construction including wall materials, air flow, power, lighting, storage, and production areas. This is further exacerbated by the size of the clean room that houses several workers.

The goal of clean rooms for the semiconductor and microelectronics industry is an ISO level 3 or 5 rating and includes the use of gowning rooms, anterooms, air locks, pass throughs, and specialized window modules. To achieve the desired clean room level, strict controls are maintained, which is difficult and a constant issue.

Every clean room constructed for semiconductors and microelectronics is unique and needs to be installed in accordance with the types of products being manufactured and the processes being used. This requires the use of design specialists that are familiar with the parameters of semiconductor and microelectronics’ construction, which, in many cases, involves working with products assembled under magnification and conducted in a noiseless environment.

Medical Device Manufacturing

Medical devices are assembled and manufactured in controlled clean room environments to ensure their integrity. Since the goal of medical devices is to help patients and prevent illness, where the devices are manufactured has to have the highest standards for cleanliness. This factor makes clean rooms used in their production a key element in the process.

Unlike other clean rooms for manufacturing, medical device clean rooms come under intense scrutiny by regulatory agencies that monitor any form of tool that will come in contact with the public. Although ISO standards determine the classification of a clean room and have specific standards for medical device manufacturing, companies still have to comply with governmental oversight. This aspect of medical instrument production creates complications and regular inspections.

Aside from the standards established by governmental agencies, there are international standards that must also be followed that are administered by the World Health Organization (WHO). The specifications and standards for medical device clean rooms cover the most minute details regarding the size, contents, location, filtration, and clothing of workers that have to be strictly followed in order to continue production.

Medical device clean rooms are designed to control airborne particulates and microorganisms. Additionally, they have to be checked for their bioburden rate, the number of bacteria living on a surface. The demands and regulations for medical device manufacturers has steadily risen over the last few years. Class III medical devices, ones that are implanted or sustain life, are the most stringently controlled.

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