Sterile Compounding Review: Who, What, Where?

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Across
  1. 4. The part of the needle that should face upward when entering a vial stopper.
  2. 5. The room or area that contains the primary engineering control.
  3. 7. This CSP category uses an ISO 5 PEC in an unclassified segregated compounding area and has short storage limits.
  4. 10. HEPA filtered air that reaches a critical site without first passing over another object.
  5. 11. A glass container that becomes an open system after its neck is broken.
  6. 15. The cleanroom space that houses the PEC and maintains controlled air quality.
  7. 17. The type of patient specific pharmacy compounding performed under Section 503A.
  8. 20. The airflow problem created when a hand or object blocks first air from reaching a critical site.
  9. 21. The pressure relationship that pulls air into a room to contain hazardous contaminants.
  10. 23. The accidental removal of a piece of a vial’s rubber stopper by a needle.
  11. 24. The type of filter that removes at least 99.97 percent of particles measuring 0.3 microns.
Down
  1. 1. The last date and time a compounded sterile preparation may be used or administered.
  2. 2. A location that must remain sterile because it comes into contact with the sterile medication, fluid pathway, or patient.
  3. 3. The process of adding a diluent to a powdered medication to create a solution of known concentration.
  4. 6. Preparation, mixing, assembling, altering, packaging, or labeling a preparation to meet a patient need.
  5. 8. What Form FDA 483 documents when inspectors identify deficiencies.
  6. 9. The area within the PEC where critical sites receive unobstructed first air.
  7. 12. The process of putting on protective clothing before entering the sterile compounding environment.
  8. 13. The engineering control where sterile compounding takes place and ISO 5 conditions must be maintained.
  9. 14. The device used when transferring medication withdrawn from an ampule into an IV bag.
  10. 16. The facility model under Section 503B that registers with the FDA and has greater federal oversight.
  11. 18. The transition area used for activities such as hand hygiene and garbing before entering the buffer room.
  12. 19. The scientific nonprofit that develops compounding standards but does not conduct routine pharmacy inspections.
  13. 22. The unclassified area where a Category 1 primary engineering control may be located.