USP Class VI polycarbonate refers to a highly purified plastic resin that meets the United States Pharmacopeia (USP) Class VI biological reactivity standards. The USP classification system tests and evaluates materials based on their biocompatibility and safety for pharmaceutical and medical use. To achieve Class VI certification, polycarbonate must pass rigorous testing.
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Systemic toxicity tests– These tests involve administering extracts from the material to live animal models, typically mice or rabbits, via intravenous or intraperitoneal injection. Researchers then monitor the animals for any signs of acute toxicity, including adverse physiological or behavioral reactions. This ensures that the material does not release harmful substances that could affect systemic health.
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Intracutaneous tests <USP 88> – Also known as irritation tests, these involve injecting material extracts into the skin (typically of a rabbit) to evaluate localized tissue responses such as redness, swelling, or inflammation. This ensures that prolonged contact with the material does not cause irritation or allergic reactions, making it suitable for pharmaceutical applications.
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Implantation tests 10993-6:2016 – These tests assess long-term biocompatibility by implanting the material directly into live tissue (often muscle or subcutaneous areas in test animals) and observing the body’s response over a prolonged period. The absence of chronic inflammation, fibrous capsule formation, or necrosis indicates that the material is safe for extended use in sensitive applications.
Materials that pass these stringent assessments ensure minimal risk of leaching, cytotoxicity, and biological interference—making them ideal for sensitive pharmaceutical applications.
Why USP Class VI Polycarbonate Matters for Bioprocessing
1. Chemical Resistance and Durability
Bioprocess containers must withstand exposure to a variety of buffers, media, and process fluids. Polycarbonate’s superior resistance to chemicals ensures that there is no contamination, degradation, or leaching, maintaining the purity of stored substances.
2. Exceptional Clarity for Visual Inspection
Unlike other plastics, polycarbonate is highly transparent, allowing for easy visual monitoring of liquid levels, particulate contamination, or color changes in stored media. This is crucial in pharmaceutical processing, where precision and quality control are paramount.
3. High Impact Strength for Secure Handling
Polycarbonate is highly impact-resistant, reducing the risk of container breakage during handling and transport. This makes it an excellent alternative to traditional glass containers, which are fragile and prone to cracking or shattering.
4. Autoclavability for Sterile Processing
One of the biggest advantages of USP Class VI polycarbonate is its ability to withstand high-temperature sterilization methods such as autoclaving. This ensures that square media bottles remain sterile and reusable, supporting stringent Good Manufacturing Practices (GMP) and regulatory compliance.
5. Regulatory Compliance and Assurance
Using USP Class VI-certified polycarbonate demonstrates compliance with global regulatory standards, including FDA, ISO 10993, and EU Pharmacopoeia. This helps pharmaceutical manufacturers mitigate risks and streamline approvals for their processes.
When selecting bioprocess containers, choosing the right material is critical to ensuring product integrity, safety, and compliance. USP Class VI polycarbonate offers a combination of biocompatibility, durability, chemical resistance, and clarity, making it the preferred choice for square media bottles used in pharmaceutical processing.
At GMP Plastics we provide high-quality, USP Class VI polycarbonate square media bottles designed to meet the demanding needs of bioprocessing applications. Contact us today to learn more about how our products can support your pharmaceutical manufacturing needs.
