QUANTIFYING CROSS-CONTAMINATION IN A MULTI-PURPOSE FACILITY: EXPERIMENTAL DESIGN AND INTERPRETATION

Where production of a single product is performed in a dedicated facility issues of cross-contamination are of less concern. Where two or more products are to be manufactured in one facility, one room within a facility or by using common the potential for cross-contamination becomes a significant issue for consideration. For this study, Pii and IES designed and executed assessment protocols to ensure adequate controls against potential cross contamination during typical manufacturing operations at Pii multi-product facility in Maryland USA. The studies simulated various unit operation activities used in making solid dosage forms; such as weighing, mixing, and tablet compression and monitored air concentrations of surrogate compounds using validated HPLC methods. An engineering-based alert limits were calculated based on procedural controls and Air-handling unit capabilities. It was concluded that, with adequate engineering and procedural controls manufacturing of potent and non-potent compounds in the same facility is possible without cross contamination risks. Applied experimental design also assessed personnel safety and calculated exposure limits. - Understand the airborne cross contamination risk presented by the manufacture of solid dose formulations in a multi-product facility - Apply industrial hygiene air sampling to assess the the airborne cross contamination risk presented by the manufacture of solid dose formulations in a multi-product facility