PHRD5045 (Exam 3) - USP Chapter 797 (Requirements for Compounding Sterile Preparations)

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daynuhmay
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PHRD5045 (Exam 3) - USP Chapter 797 (Requirements for Compounding Sterile Preparations)
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2013-11-15 05:14:09
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USP Chapter 797 Requirements Compounding Sterile Preparations
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USP Chapter 797 (Requirements for Compounding Sterile Preparations)
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  1. principal source of contamination in CSPs
    direct contact
  2. what will ultimately determine the success or failure of any cleanroom policy
    attitude towards cleanliness
  3. non-viable particle
    does not contain a living organism, but acts as transportation for viable particles
  4. viable particles
    • contain 1+ living microorganisms
    • can affect sterility of CSP
    • generally ~0.2-30um
  5. 3 sources of contamination
    • 1) materials used in compounding
    • 2) environment
    • 3) personnel
  6. 4 areas of responsibility cited in USP797
    • emphasis on...
    • 1) training & education
    • 2) compounding accuracy
    • 3) avoiding contamination
    • 4) patient safety
  7. types of engineering devices CSPs must be maintained in
    ISO Class 5
  8. most common mode of human transmission is via...
    hands
  9. how often must personnel undergo training/evaluation for low-medium risk compounding
    at least annually
  10. how often must personnel undergo training/evaluation for high-risk level compounding
    at least semiannually
  11. BUD
    beyond use date
  12. 4 CSP Risk Categories
    • 1) immediate use
    • 2) low-risk (subsection: low-risk w/ 12hr or less BUD)
    • 3) medium-risk
    • 4) high-risk
  13. 1:1 risk level
    low-risk
  14. 1:many or many:1 risk level (# components >3)
    medium-risk
  15. risk level of any ingredient-CSP relationship using nonsterile ingredients/devices requiring terminal sterilization
    high-risk
  16. immediate-use risk BUD (RT; 4o; -20o)
    1hr; 1hr; n/a
  17. low-risk BUD (RT; 4o; -20o)
    48hr; 14 days; 45 days
  18. medium-risk BUD (RT; 4o; -20o)
    30hr; 9 days; 45 days
  19. high-risk BUD (RT; 4o; -20o)
    24hr; 3 days; 45 days
  20. how all CSPs repackaged from SDVs should be treated
    as a medium-risk level CSP
  21. when must administration of immediate-use drugs begin?
    within 1 hour after the start of preparation
  22. category involving single volume transfers with no additional aseptic manipulation for no more than 3 sterile products into 1 container of sterile product
    low-risk level w/ >12hr BUD
  23. 3 manipulations low-risk levels are limited to
    • 1) aseptically opening ampules
    • 2) penetrating sterile stoppers w/ sterile needle & syringe
    • 3) sterile transfer of sterile liquids to sterile end containers
  24. category involving multiple individual or small doses of sterile products combined/pooled to prepare a CSP that will be admin either to multiple pts or to one pt on multiple occasions
    medium-risk
  25. category involving non-sterile to sterile compounding
    high-risk
  26. BUD of multiple dose vials
    28 days after initial entry unless otherwise specified
  27. when can SDV's be repackaged into multiple single-use vehicles?
    when performed under ISO Class 5 conditions
  28. type of airflow required for exposure of critical sites
    unidirectional airflow
  29. Class 5 particle count per m3 & ft3
    3520; 100
  30. Class 7 particle count per m3 & ft3
    352,000; 10,000
  31. Class 8 particle count per m3 & ft3
    3,520,000; 100,000
  32. secondary engineering control areas (2)
    • ISO 7 buffer area 
    • ISO 8 ante area
  33. primary engineering control area
    ISO 5
  34. "First Air"
    air exiting the HEPA filter in a unidirectional air-stream and is virtually free of particulate contaminants
  35. DCA
    direct compounding area
  36. only portion of the PEC dedicated to the task of aseptic manipulation & must be continuously exposed to unidirectional HEPA-filtered air during aseptic manipulation
    DCA
  37. what can improper hand placement do during aseptic manipulation?
    disrupt first air
  38. how often disinfection should occur in ISO5 environment (4)
    • 1) start of each work shift
    • 2) beginning of each batch
    • 3) at least every 30min
    • 4) surface contamination known/suspected
  39. how should cleaning proceed?
    • buffer area (cleanroom) to ante area 
    • -> cleanest to dirtiest (backwards from donning)
  40. designed to demonstrate that the primary and secondary engineering controls, disinfecting procedures, and work practices result in a suitable environment for aseptic compounding
    environmental sampling

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