Evaluation of Containment Ventilated Enclosure Performance in Absence of Negative Pressure Containment Secondary...

Area of Science:

• Pharmaceutical Compounding
• Occupational Safety
• Environmental Monitoring

Background:

• High-particle generating compounding procedures pose risks of airborne powder exposure.
• Secondary engineering controls are often used to mitigate exposure during compounding.
• The efficacy of containment ventilated enclosures (CVEs) as a primary engineering control needs evaluation.

Purpose of the Study:

• To assess the effectiveness of a containment ventilated enclosure in preventing powder exposure during high-particle generating compounding.
• To evaluate compounder and room exposure to estradiol powder in the absence of negative pressure secondary controls.

Main Methods:

• Air sampling was conducted during estradiol powder compounding within a CVE.
• Performance of the CVE was verified using velocity and smoke testing.
• Compounding involved weighing, transfers, trituration, and capsule filling by three compounders.
• Laboratory detection limits were established to ensure accurate sample analysis.

Main Results:

• All air samples collected inside and outside the CVE showed less than detectable amounts of estradiol.
• Despite observed potential for particle generation (spills, equipment jostling), no estradiol was detected externally.
• Exposure to estradiol powder for compounders and the surrounding room was minimal.

Conclusions:

• A properly certified containment ventilated enclosure significantly minimizes powder chemical exposure to compounders.
• CVEs are effective in preventing room exposure to aerosolized compounds, even without negative pressure secondary controls.
• Containment ventilated enclosures serve as a viable primary engineering control for hazardous powder compounding.