Secondary Engineering Controls
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Secondary engineering controls refer to the ante area and buffer area that separate the primary engineering control (PEC) area from the surrounding environment. The buffer area must meet or exceed ISO Class 7 standards with a minimum of 30 air changes per hour, while the ante area must meet or exceed ISO Class 8 standards with a minimum of 20 air changes per hour. These areas have increased air supply, HEPA filtration, and room pressurization compared to ordinary rooms. The configuration and requirements of the secondary engineering controls depend on the risk level of the compounded sterile preparations.
Secondary Engineering Controls
- 1. The Basics of Secondary Engineering Controls
- 2. The environments leading to the ISO Class 5 Primary Engineering Control Area (PEC) are referred to as Secondary Engineering Controls
- 3. Simply put, the ante area and the buffer area are Secondary Engineering Controls
- 4. Secondary Engineering Controls differ from ordinary ventilated rooms by having increased air supply, HEPA filtration, and room pressurization.
- 5. The buffer area must meet or exceed ISO Class 7 standards
- 6. The ante area must meet or exceed ISO Class 8 standards (ISO Class 7 if the ante room opens into a negative pressure area)
- 7. Conceptual representation of Secondary Engineering Controls in relationship to PECs and the DCA Dirtiest Cleanest Buffer area ISO Class 7 PEC ISO Class 5 DCA Ante area ISO Class 8
- 8. Both the ante area and buffer area must maintain their ISO Class during dynamic working conditions, i.e. when people are doing their jobs.
- 9. The buffer area must maintain a minimum of 30 air changes per hour (ACPH) under dynamic conditions.
- 10. The ante area must maintain a minimum of 20 air changes per hour (ACPH) under dynamic conditions if ISO Class 8, or 30 ACPH if ISO Class 7
- 11. Positive pressure is required from the buffer area to the ante area for non-hazardous preparations
- 12. Negative pressure is required from the buffer area to the ante area for hazardous preparations
- 13. The ante area and buffer area for low-risk and medium-risk compounding may be separated by physical barriers (walls and doors), or by a line of demarcation.
- 14. The ante area and buffer area for high-risk and hazardous compounding require physical separation, i.e. walls and doors
- 15. Facility requirements are summarized in the following table…
- 16. Low-Risk Medium-Risk High-Risk Hazardous Drugs Architectural Style Open or Closed Open or Closed Closed Closed Buffer area ISO Class ISO Class 7 or better ISO Class 7 or better ISO Class 7 or better ISO Class 7 or better Ante area ISO Class ISO Class 8 or better (Class 7 if opens into negative pressure area) ISO Class 8 or better (Class 7 if opens into negative pressure area) ISO Class 8 or better (Class 7 if opens into negative pressure area) ISO Class 7 or better Minimum ACPH for buffer area 30 30 30 30 Minimum ACPH for ante area 20 if ISO 8 30 if ISO 7 20 if ISO 8 30 if ISO 7 20 if ISO 8 30 if ISO 7 30 Pressure Positive Positive Positive Negative Table adapted from: American Society of Health-System Pharmacists. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2014;71:145-66