What Is USP Class VI Polycarbonate?
USP Class VI is a classification defined by the United States Pharmacopeia (USP) that designates materials suitable for use in medical and laboratory environments. To earn this rating, a plastic must undergo a rigorous battery of biological tests to confirm that it is non-toxic, non-irritating, and non-reactive when exposed to biological systems.
The Testing Process for USP Class VI Plastics
USP Class VI testing includes three key evaluations:
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Systemic Injection Test: This involves injecting extracts of the material into laboratory animals to evaluate for systemic toxicity, such as changes in behavior, weight, or internal organ function. The material must produce no adverse effects.
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Intracutaneous Test: Here, the material’s extract is injected under the skin to assess for localized irritation, such as redness, swelling, or inflammation. A passing grade means there are no significant reactions.
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Implantation Test: This long-term evaluation involves implanting the material into living tissue to observe for chronic toxicity, tissue damage, or inflammation over time.
Passing all three tests confirms that the plastic is biocompatible and safe for use in sensitive applications such as cell culture, diagnostic assays, and pharmaceutical manufacturing.
Why Choose Polycarbonate?
Polycarbonate is already a go-to material in labware due to its strength, clarity, and thermal stability. It can withstand repeated autoclaving, resist impact, and provide excellent visibility for monitoring cultures or reagents. When polycarbonate is certified as USP Class VI, it also guarantees a high level of biocompatibility—making it safe for contact with cells, tissues, and biologics.
This combination of physical durability and biological safety makes USP Class VI polycarbonate ideal for a wide range of labware. Products like shaker flasks, media bottles, and transwell membrane plates frequently use this material to ensure clean, reliable, and reproducible results.
The Importance in Regulated Environments
For labs operating under GMP, GLP, or ISO-certified processes, the use of certified materials like USP Class VI polycarbonate is not only a best practice—it’s often a regulatory requirement. Using certified lab plastics helps ensure compliance while minimizing the risk of variability caused by material contamination or degradation.
