Authors & ContributorsCara Plese
July 27, 2016
Foreign particulate in drug products originate from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces. Typical contaminants include polymers, fibers, burnt material and metallic particulate. Hair is a significant type of contamination seen in pharmaceutical products. The biological nature of hair can generate many types of concerns when this contaminant is found in drug products. Identification of hair as a contaminant and narrowing down possible sources of contamination can aid in determining the impact on product. It can also provide valuable information to remediate the problem in the future.
Microscopy is a valuable tool in the analysis process, enabling a scientist to accurately determine if a contaminant is a hair. Microscopy also provides additional relevant information, such as hair type (i.e. human, animal or textile in nature) that can lead to the source of the contamination.
Participants of this webinar will learn how microscopy is used to identify hairs and what characteristics the analyst evaluates to determine potential sources of hair contamination.