Cleanroom Certification And Qualification

Cleanroom Certification And Qualification

CLEANROOM CERTIFICATION AND QUALIFICATION

What is a cleanroom?
A cleanroom is an environment in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.  (W. Whyte, Cleanroom Design).

Brief history

• Its roots go as far back as a century ago, in the attempts to control infections in healthcare facilities.
• The need to clean manufacturing environment is a requirement of modern society.
• Pioneer microbiologists such as Pasteur, Koch, and Lister have established that bacteria cause infections in injuries.
• To eliminate bacteria in healthcare facilities environment (especially in surgery rooms) might prevent infection.

These were the scientific basis for conception of first cleanrooms.
The demand for cleanrooms in industry arose during Second World War, in an attempt to improve quality and reliability of instruments applied to weapons. These rooms “copied” projects used in surgery rooms.
Healthcare facilities wanted environments with no bacteria.
Industries wanted environments with no particles.
Research into nuclear reactions, both for peace and war purposes, as well as biological and chemical research for war purposes were the major forces behind the development of the high-efficiency particulate air (HEPA) filter. HEPA filters were needed to avoid both radioactive substances and dangerous microbes’ contamination.

Cleanroom essential features

1.  Very low concentration of particles in the air, which might carry microbes that may reproduce and cause infection.
2.  Very low concentration of particles in the air, which might cause equipment ill-functioning or reduce its useful life.

Current applications

1.  Electronics – production of computers, magnetic tapes, flat screens;
2.  Semiconductor devices – production of integrated circuits;
3.  Micro-mechanisms – gyroscopes, micro-rollers, CD players;
4.  Optics – special lenses, laser equipment;
5.  Biotechnology – production of antibiotics, genetic engineering;
6.  Pharmaceutics – sterile products;
7.  Medical devices – heart valves, prostheses, products for parenteral alimentation;
8.  Healthcare facilities – treatment of patients with no or very low immunity level, isolation rooms, surgery rooms.