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The Basics of Primary Engineering Controls

A brief overview of what constitutes a Primary Engineering Control (PEC), aka "hoods" in pharmacy iv rooms.

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The Basics of Primary Engineering Controls

  1. 1. Primary Engineering Controls THE BASICS
  2. 2. The area required to accommodate the preparation of CSPs is the Direct Compounding Area (DCA) located within the Primary Engineering Control Area (PEC)
  3. 3. A PEC is a device or room that provides an ISO Class 5 environment for compounding CSPs.
  4. 4. While a PEC can be a room, it is commonly a hooded area that is certified to ISO 5 standards found within the ISO Class 7 Buffer area
  5. 5. Conceptual representation of PEC in relationship to the DCA and Buffer area Dirtiest Cleanest Buffer area ISO Class 7 PEC ISO Class 5 DCA
  6. 6. PECs rely on high efficiency particle air (HEPA) filters to maintain ISO Class 5 standards
  7. 7. HEPA filters are >99.99% efficient in removing particles as small as 0.3 microns in size
  8. 8. The unidirectional (horizontal or vertical) HEPA- filtered air provides enough velocity to sweep particles away from the DCA and maintain unidirectional flow during preparation of CSPs.
  9. 9. PECs typically include 3 types of “hoods”
  10. 10. Laminar Airflow Workbenches (LAFWs) – “Horizontal Hood” Horizontal airflow Air is drawn in through a pre-filter before passing through the HEPA filter. Filtered air is blown horizontally across the hood work surface Most common “hood” found in pharmacy IV rooms
  11. 11. Biological Safety Cabinets (BSCs) – “Vertical Hood” Vertical airflow Air is drawn in through a pre-filter before passing through the HEPA filter. Filtered air is blown vertically onto the hood work surface Often referred to as a “chemo hood”
  12. 12. Compounding Aseptic Isolators (CAIs) and Compounding Aseptic Containment Isolators (CACIs)
  13. 13. CAIs and CACIs are commonly referred to as “glove boxes”
  14. 14. CAIs and CACIs have an anti chamber (pass- through chamber) and a completely enclosed compounding chamber
  15. 15. The anti chamber allows access to compounding material without exposing contents to outside air
  16. 16. CAIs and CACIs are fitted with gloves to manipulate compounding material inside "the box“
  17. 17. What’s the difference between a CAI and a CACI?
  18. 18. CACIs use negative pressure and can be used for hazardous compounding, while CAIs use positive pressure and cannot be used for hazardous compounding
  19. 19. USP Chapter <797> states that CAIs and CACIs shall be placed in an ISO Class 7 buffer area unless they meet all of the following conditions: Provides isolation from the room and maintains ISO Class 5 during dynamic operating conditions Particle counts sampled upstream of the critical exposure site shall maintain ISO Class 5 levels during compounding operations Not more than 3520 particles (0.5 mm and larger) per meter shall be counted during material transfer