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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.
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
Related Resources
- Brochure: In Vitro Biocompatibility Testing
- Service: In Vitro Biocompatibility
- Service: In Vitro Skin Irritation Testing
- Service: In Vitro Cytotoxicity Testing
- Industry: Medical Devices
- Blog: Principles and Strengths of In Vitro Testing
- Blog: The Conspicuous Case of the Missing T0 in ISO 10993-5 Cytotoxicity Testing
- Application Note: Next Steps After Receiving a Cytotoxic Result
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