Advertisement

Standards for Contamination Control Areas

  • Alvin Lieberman

Abstract

The objective of standards and specifications used for contamination control is to establish controls and definitions that will allow satisfactory cleanroom construction and good product fabrication within cleanrooms. Application of the standards permits exchange of definitions and conditions so that a cleanroom design, performance, and operation can be understood in any area as long as it is defined in accordance with accepted standards. The standards and specifications apply to the design, construction, performance, and operation of the cleanroom. The standards are necessary because design engineers, contractors, equipment manufacturers, materials suppliers, process tool producers, cleanroom owners, quality control managers, and product purchasers are all involved with cleanroom operation and must understand one another. Contamination control document standards must define clearly and acceptably:
  • Cleanliness levels for the cleanroom and the product

  • Conditions when measurements are to be made

  • Design and construction requirements for the cleanroom and for components used within the cleanroom

  • Airflow and environmental conditions within the room

  • Materials and tools allowed within the cleanroom for processing and manufacturing

  • Test methods for definition of cleanroom quality

  • Personnel training and activity requirements

Keywords

Contamination Control Optical Particle Counter Flow Control System Current Good Manufacture Practice Cleanliness Level 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. American Society of Testing and Materials, 1983. Standard Specification for Reagent Water, ASTM D 1193–77. Annual Book of ASTM Standards, Vol. 11.01. Philadelphia, PA: ASTM.Google Scholar
  2. Balazs, M. A., & Poirier, S. J., 1984. Those Confusing Pure Water “Specifications”: Setting the Record Straight. Microelectronics Manufacturing and Testing 7(2):22–23.Google Scholar
  3. Couture, S. D., & Capaccio, R. S., 1984. High-Purity Process Water Treatment for a Microelectronic Device Fabrication Facility. Microcontamination 2(2):45–49.Google Scholar
  4. Edmark, K. W., & Quackenbos, G., 1984. An American Assessment of Japanese Contamination Control Technology. Proceedings of the 30th Institute of Environmental Science Annual Technical Meeting, pp. 24–31, May 1984, Anaheim, CA.Google Scholar
  5. Food and Drug Administration, 1987. Guideline on Sterile Drug Products Produced by Aseptic Processing. Rockville, MD: Center for Drugs and Biologies and Office of Regulatory Affairs, FDA.Google Scholar
  6. Institute of Environmental Science, 1984. Compendium of Standards, Practices, Methods and Similar Documents Relating to Contamination Control. IES-CC-009-84. Mt. Prospect, IL: IES.Google Scholar
  7. Kasper, G., Wen, H. Y., & Wang, H. C, 1989. Developing Particle Standards for Cylinder Gases. Microcontamination 7(1): 18–26.Google Scholar
  8. Marshall Space Flight Center, 1980. NASA Standard Procedures for the Microbio logical Examination of Space Hardware, NHB 53401 B.Google Scholar
  9. National Aeronautics and Space Administration, 1967. NASA Standard for Clean Room and Work Stations for Microbially Controlled Environments. NASA Publication NHB 5340.2, Washington, DC: NASA.Google Scholar
  10. National Sanitation Foundation, 1976. Class II (Laminar Flow) Bio hazard Cabinetry. NSF STD #49, Ann Arbor, MI: NSF.Google Scholar
  11. Schicht, H. H., 1989. Contamination Control Standards and Recommended Practices for Pharmaceutical Production in Europe. Swiss Contamination Control 2(6): 11–19.Google Scholar
  12. Seeger, G. A., 1983. Microbiological Standards for Clean Rooms. Proceedings of the 29th Institute of Environmental Sciences Annual Technical Meeting, pp. 297–300, May 1984, Dallas, TX.Google Scholar
  13. United States Pharmacopeia, Vol. 21, 1985. <788> Particulate Matter in Injections; Large Volume Parenterals, p. 1287. Washington, DC: United States Pharmacopeial Convention.Google Scholar
  14. United States Pharmacopeia, Vol. 22, 1989. <788> Particulate Matter in Injections: Small Volume Injections, p. 1596. Washington, DC: United States Pharmacopeial Convention.Google Scholar

Copyright information

© Van Nostrand Reinhold 1992

Authors and Affiliations

  • Alvin Lieberman

There are no affiliations available

Personalised recommendations