Frequently Asked Questions About In Vitro Irritation and Cytotoxicity Testing

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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.

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

Learn more about the EAG In Vitro Biocompatibility Laboratory.

Reach out to our team for help with your in vitro testing project.