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Specifically designed for pharmaceutical and biological manufacturing, Thermo Scientific™
Nalgene™ Polycarbonate Biotainer™ Bottles and Carboys reduce the risk of carry-over
contamination. Durable, translucent PC construction ensures the integrity of your sample, even
frozen to -100°C.
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Provided sterile and ready-to-use; including certified clean products, which meet USP<788> standards and endotoxins below 0.5 EU/mL
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Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms
描述
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Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms
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Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the bottle/closure
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Robust, PC can be used from -100ËšC to 100ËšC, allowing for both heated mixing and frozen storage or shipment. Must be tested in actual use conditions as results may vary depending upon application.
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Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications
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All container/closure systems are certified leakproof** to protect valuable contents
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Products can be supplied with forced extraction studies*, validation binders* and certificates
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Customer support includes our highly experienced commercial specialist teams, regulatory team, quality team and regional technical support
Additionally our certified clean products include:
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Clean room produced in ISO Class 7 to limit particulates during molding
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Two heat-sealed sterile barriers to protect product prior to use
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Heat-sealed bags include quick-tears on the top and bottom and placed in carton liner twisted and tape/tie sealed to prevent gross contamination on the inner packaging
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Certified and lot-to-lot tested to meet USP <788> low particulate requirements to limit potential particulate contamination
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Certified low endotoxin (0.50 EU/mL) according to USP <85> to reduce pyrogens
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