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Pharmacy Cleanroom Basics


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A basic look at the definition of a pharmacy cleanroom.

Published in: Healthcare
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Pharmacy Cleanroom Basics

  1. 1. Pharmacy Cleanroom Basics
  2. 2. Achieving and maintaining sterility and preventing contamination of all compounded sterile products (CSPs) is paramount for patient safety
  3. 3. Ensuring sterility and preventing contamination requires that pharmacies prepare CSPs in a cleanroom
  4. 4. Cleanrooms are most well known for use in other industries like the semiconductor industry. However, the use of cleanrooms has become essential for safely preparing CSPs in acute care hospitals.
  5. 5. According to USP Chapter <797>, a cleanroom [also referred to as a buffer area] is “a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.”
  6. 6. The cleanroom is an area where primary engineering controls (PECs)* are located and where preparation, compounding, and staging of CSPs occur *a.k.a. “hoods”
  7. 7. The cleanroom differs from “ordinary rooms” by controlling the environment and limiting the concentration of airborne particles generated by people, processes, facilities, and equipment.
  8. 8. The cleanroom environment is controlled by using increased air supply, HEPA filtration, and pressurization, for example.
  9. 9. Hand hygiene, garbing, order staging, and other “high-particulate-generating activities” may not be performed in the cleanroom.
  10. 10. Activities such as hand hygiene and garbing must take place in the anteroom, which is an area outside the cleanroom
  11. 11. Example of Anteroom in relationship to the Buffer Area (cleanroom)
  12. 12. The cleanroom must be certified ISO Class 7, while the anteroom must be ISO Class 8 or better
  13. 13. What does ISO Class 7 and ISO Class 8 mean?
  14. 14. ISO Class refers to a set of standards developed by The International Organization for Standardization
  15. 15. ISO is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards
  16. 16. ISO standards include ISO 14644-1, which defines the level of airborne particulate cleanliness applicable to a cleanroom
  17. 17. Airborne particle cleanliness in ISO 14644-1 is expressed in terms of ISO Class N Examples include ISO Class 7 and ISO Class 8
  18. 18. ISO Class represents the maximum allowable concentrations of particles per cubic meter of air for considered sizes of particles (particles per cubic foot for Federal Standard 209e†) †Fed Std 209e was officially cancelled on November 29, 2001, but is still widely cited. The U.S. federal government now uses the terminology set forth by the ISO.
  19. 19. Cleanrooms are classified by particle sizes ranging from 0.1 micron to 5 microns. For purposes of USP <797> the 0.5-micron particle size is used.
  20. 20. The following table shows the ISO classification of particulate matter in air
  21. 21. As you may have noticed in the table, cleanrooms may also be referred to as "class 100" or "class 1000"
  22. 22. “class 100" and “class 1000" refer to Federal Standard 209e, and denote the number of 0.5-micron or larger particles permitted per cubic foot of air
  23. 23. Even though Federal Standard 209e was officially cancelled by the General Services Administration on November 29, 2001, the terminology is still widely used.
  24. 24. Because 1 cubic meter is approximately 35 cubic feet, the two standards are mostly equivalent when measuring 0.5-micron particles. For example, 3,520 particles of 0.5-microns per cubic meter (ISO Class 5) is equivalent to 100 particles per cubic foot (Class 100)
  25. 25. For the sake of comparison, “ordinary room air” is approximately class 1,000,000 or ISO 9
  26. 26. Cleanrooms are a valuable tool to prevent particulate and microbial contamination while compounding sterile products. However, it is important to remember that cleanrooms are only one piece of the puzzle.
  27. 27. Pharmacies must remember to control items that enter and leave the cleanroom - and personnel must utilize impeccable aseptic technique - to ensure contamination-free CSPs
  28. 28. More information can be found in the following references: The United States Pharmacopeia, 37th rev., and The national formulary, 32nd ed. USP General Chapter <797>. Pharmaceutical Compounding - Sterile Preparations. Rockville, MD: The United States Pharmacopeial Convention; 2014. ASHP Guidelines on Compounding Sterile Preparations. American Journal of Health- System Pharmacy. 2013;71(2):145-166. ASHP discussion guide for compounding sterile preparations: summary and implementation of USP chapter 797.