Exposure to Lactose During Material Transfers Involving 25 kg Of Active Pharmaceutical Ingredient
Downflow booths are used in the pharmaceutical, fine chemical and food industries, for operations such as sampling, grinding, dispensing and filling, which generate airborne particles; when processes involve hazardous, toxic or sensitizing materials and when operators, adjoining areas require protection from exposure to aerosols of the process materials.
Surrogate Powder Containment testing on an Esco Pharmacon Downflow Booth (model DFB-1.5S1-10-C, serial number 2009-38070) was conducted to assess the performance characteristics of these booths in containing and controlling airborne concentrations of particulate powders generated during typical powder handling and transfer operations. Three test iterations were conducted, each involving the transfer of 25 kg of lactose from a bulk product drum into a receiving drum. The tests results prove that the booth delivers excellent containment significantly below industry-accepted criteria.
Bulk product drum and receiving drum are de-lidded and the inner liners are staged
Operator is scooping the lactose from bulk product drum
Operator is transferring the lactose into receiving drum
Operator is taking the inner liner out from bulk product drum
Operator is dicharging the lactose directly to receiving drum
Liners are tied off
Drums are re-lidded
Sampler cassette on operator breathing zone
Position of overall samplers