Client Description: Pharmaceutical Manufacturing Facility
During multiple survey dates, a total of 32 area and personal air samples for lactose were collected in order to determine the effectiveness of the containment system. Note that lactose was used during the monitoring sessions as the surrogate for the planned use of hazardous active pharmaceutical ingredients (APIs).
The handling of APIs was to take place in a contained Class 100,000 Clean Room. The materials that were expected to be processed in the production area were considered extremely hazardous and required an occupational exposure banding (OEB) 5 Facility Design Classification. The client had established an internal 8-hour time-weighted average (TWA) occupational exposure limit (OEL) for such APIs. Consequently, the production process requires total containment and isolator technology was utilized.
A total of 32 area and personal samples for lactose were collected in the production area in order to determine the effectiveness of the containment system. These samples were divided into three groups, namely: baseline samples; background samples; and personal samples. The baseline samples were area samples that were collected to determine the background environmental lactose levels before any work activities were performed on that survey date. The background samples, which were also area samples, were collected to determine if leakage of lactose occurred at the containment barriers during the subject operations. And finally, the personal samples were collected in the breathing zones of workers to determine exposure potential data attributable to leakage of lactose at barriers when dispensing and packaging operations were performed.
The air sampling results indicated that lactose was not detected at or above the laboratory analytical detection limits listed among all baseline and background area samples. With only one exception, lactose was not detected at or above the laboratory analytical detection limits listed among all the personal samples collected. All listed detection limits were below the OEL for APIs established by the client. The lone exception involved a sample collected in the breathing zone of one employee while performing a lactose dispensing operation over one discrete partial shift period. While a detectable concentration was identified during a portion of a shift, the overall personal exposure level datum for that shift did not exceed the client’s internally established 8-hour time-weighted average OEL. Note that two other samples were collected in that latter employee’s breathing zone during other discrete shift periods, both of which showed no detectable lactose at or above the laboratory detection limits listed. B ased on the data and observations made, HygieneTech concluded that the one detectable lactose level was, more likely than not, a result of atypical operations.
Work practice controls were put in place to address the cause of the single detectable datum recorded and, with those controls in place, HygieneTech believed that the total containment system would meet the controlling standard during future production runs of APIs, provided that employees consistently perform all operations in strict accordance to the specified standard operating procedures.
