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The Basics of Primary Engineering Controls
The Primary Engineering Control (PEC) provides an ISO Class 5 environment for compounding sterile preparations. A PEC is commonly a hooded work area within an ISO Class 7 buffer room that uses HEPA filtration to maintain ISO Class 5 air quality. There are three main types of PECs: laminar airflow workbenches with horizontal airflow; biological safety cabinets with vertical airflow; and compounding aseptic isolators or containment isolators, commonly called "glove boxes," which have enclosed compounding chambers that can be accessed through gloves. The key difference between compounding aseptic isolators and containment isolators is that containment isolators use negative pressure and can be used for hazardous compounding, while isolators use positive pressure and
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The Basics of Primary Engineering Controls
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- 2. The area requiredto accommodate the preparation of CSPs is the Direct Compounding Area (DCA) located within the Primary Engineering Control Area (PEC)
- 3. A PEC isa device or room that provides an ISO Class 5 environment for compounding CSPs.
- 4. While a PECcan 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. Conceptual representation ofPEC in relationship to the DCA and Buffer area Dirtiest Cleanest Buffer area ISO Class 7 PEC ISO Class 5 DCA
- 6. PECs rely onhigh efficiency particle air (HEPA) filters to maintain ISO Class 5 standards
- 7. HEPA filters are>99.99% efficient in removing particles as small as 0.3 microns in size
- 8. The unidirectional (horizontalor vertical) HEPA- filtered air provides enough velocity to sweep particles away from the DCA and maintain unidirectional flow during preparation of CSPs.
- 9. PECs typically include 3types of “hoods”
- 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. 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. Compounding Aseptic Isolators(CAIs) and Compounding Aseptic Containment Isolators (CACIs)
- 13. CAIs and CACIsare commonly referred to as “glove boxes”
- 14. CAIs and CACIshave an anti chamber (pass- through chamber) and a completely enclosed compounding chamber
- 15. The anti chamberallows access to compounding material without exposing contents to outside air
- 16. CAIs and CACIsare fitted with gloves to manipulate compounding material inside "the box“
- 17. What’s the differencebetween a CAI and a CACI?
- 18. CACIs use negativepressure and can be used for hazardous compounding, while CAIs use positive pressure and cannot be used for hazardous compounding
- 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
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