USP Class VI Testing for Polypropylene
For polypropylene to meet USP Class VI standards, it must pass the following tests:
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Systemic Toxicity Test (Acute Toxicity)
- Evaluates whether any leachable chemicals from the material cause systemic toxicity when introduced into a biological system.
- This test is performed by injecting material extracts into test animals and monitoring for any harmful reactions.
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Intracutaneous (Irritation) Test
- Determines if the material causes irritation or inflammatory reactions when placed in contact with tissues.
- Extracts from the material are injected into the skin to check for localized reactions such as redness or swelling.
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- Assesses the long-term compatibility of the material when implanted in body tissues.
- A small sample of the polypropylene is implanted in an animal model to observe tissue response over time.
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Physicochemical Testing (USP <661>)
- Examines the chemical properties of plastic materials, including extractables and leachables.
- Ensures the material does not release harmful chemicals into pharmaceutical products or laboratory samples.
Why USP Class VI is Important for Polypropylene in Laboratory Work
- Ensures Biocompatibility: USP Class VI-certified polypropylene is safe for use in pharmaceutical and biomedical applications.
- Prevents Contamination: The standard confirms that the material does not leach harmful substances that could interfere with research or medical treatments.
- Supports Regulatory Compliance: Many industries, including pharmaceuticals and medical device manufacturing, require compliance with USP Class VI for approval.
In summary, while USP does not have a unique standard dedicated solely to polypropylene, compliance with USP <88> (Class VI) and USP <661> (physicochemical tests) ensures that polypropylene used in laboratory, pharmaceutical, and medical applications is safe, reliable, and biocompatible.
