Frequently Asked Questions About In Vitro Irritation and Cytotoxicity Testing

What is an In Vitro Cytotoxicity Assessment?

Biocompatibility assessments are a battery of tests performed to evaluate a product, medical device, or other material for the risk of biological hazards. The first test performed is typically a cytotoxicity evaluation. This is done by preparing an extract of the sample to treat a monolayer of healthy mammalian cells in vitro. Results of this assay can indicate the potential toxicity risk a product carries without testing on animals.

What is an In Vitro Irritation Assessment?

Irritation is a localized non-specific inflammatory response to a single, repeated, or continuous application of a substance or material. The in vitro irritation test involves an extraction in physiologically relevant solvents. These extracts are applied to a reconstructed human epidermis model which contains the major layers of cells that are found in a true human epidermis. Death of the cells in this model after exposure to the extracts collected from a product indicate that an irritating substance was leached off the material and poses a risk of adverse reactions in the end user.

in vitro biocompatibility testing

Who Should Perform Cytotoxicity or Irritation Assessments?

  • Manufacturers in the Chemical, Consumer Products, Medical Device, Pharmaceutical, or Raw Materials industries
  • Developers of medical devices that will undergo a biological risk evaluation for FDA approval
  • Biotechnology engineers in the research, development, or pre-clinical stages of product manufacture
  • Toxicologists planning biological risk evaluations of a product or device
  • Designers of wearable products/tech (smart watches, earbuds, etc)

When Can Cytotoxicity or Irritation be Assessed?

  • During the selection of raw materials for product development to ensure independent components do not carry toxic risk
  • When determining manufacturing steps for scaling, processing, sterilization, and packaging
  • Once the final product is produced
  • After any changes are made to the raw materials, manufacturing process, manufacturing environment, or product processing
  • To determine conditions of product usage, storage, or transport, or due to changes in these conditions

Why Assess Cytotoxicity?

  • Determine the safety of a final product before market release
  • To meet FDA regulations for medical devices
  • As a quality control measure for product batch variation
  • After the identification of contaminants by chemical characterization to determine if the contaminants are present at a potentially cytotoxic dose
  • To demonstrate that materials of construction are of the marketed biocompatible quality

Why Assess Irritation?

  • As a quality control measure for product batch variation
  • To demonstrate that materials of construction are of the marketed biocompatible quality
  • As a risk management measure for consumer product companies
  • To ensure that cleaning processes used on the product do not leave irritating residues
  • Check that changes to the manufacturing process do not integrate irritants into he product
  • To evaluate the product after packaging to ensure shipping conditions/materials do not introduce irritants to the end user that were not in the original product

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