Hair as a Pharmaceutical Contaminant: How It Is Identified, and How We Can Tell Where It Originated

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  • When: July 27, 2016
  • Time: 2PM
  • Presenter: Cara Plese, Scientist
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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

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.

Presenter Bio

Cara Pleas, M.S., Scientist I

Cara Plese

Cara Plese, Scientist, Gateway Analytical

Cara Plese is currently working as a Level II scientist at Gateway Analytical. Cara specializes in using light microscopy, SEM-EDS, FTIR, and Raman analytical techniques for manual particulate analysis. She also performs criminal forensic analyses including gunshot residue (GSR), hair and unknown material. She is a court-qualified expert in GSR analysis in three states. Cara has a Bachelor of Science degree in chemistry from LaRoche College and a Master of Science degree in forensic science, with a focus on trace and physical evidence, from Virginia Commonwealth University. She has been with Gateway Analytical for five years.

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