To improve the quality of quantitative containment design for active pharmaceutical ingredients (API) handling, JGC has developed a new assessment technique of airborne API concentration, in which the concentration of airborne API can be quantitatively assessed by expressing the powder-type-dependent airborne particle generation as an airborne index. By using this assessment technique, the airborne API concentration in an actual work environment can be more accurately estimated based on the test results obtained through a verification test using a surrogate powder such as lactose.
Features
Use of this assessment technique ensures that the airborne API concentration in the facility can be satisfactorily predicted.
The airborne index can be measured using a powder sample of 0.1 to 1 g.
Particulate containment performance evaluation is possible with respect to both equipment performance and work procedures.
Applications
Particulate containment design in response to the anticipated degree of powder dust generation
Translation of surrogate test powder data into actual powder data
Experience
Particulate containment performance evaluation of a solid pharmaceuticals manufacturing system for Company A
Patent application for this technique has been filed.
