Nalgene® 383410-42 Certified Clean PC Biotainer Carboy, Low Particulate, 10 Liter, case/2

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.

Provided sterile and ready-to-use; including certified clean products, which meet USP 788 standards and endotoxins below 0.5 EU/mL
Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms

Features:

• Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms
• Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the bottle/closure
• 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.
• Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications
• All container/closure systems are certified leakproof** to protect valuable contents
• Products can be supplied with forced extraction studies*, validation binders* and certificates
• Customer support includes our highly experienced commercial specialist teams, regulatory team, quality team and regional technical support

Additionally our certified clean products include:

• Clean room produced in ISO Class 7 to limit particulates during molding
• Two heat-sealed sterile barriers to protect product prior to use
• 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
• Certified and lot-to-lot tested to meet USP <788> low particulate requirements to limit potential particulate contamination
• Certified low endotoxin (0.50 EU/mL) according to USP <85> to reduce pyrogens

Dimensions:

• Closure Size: 48 mm
• Diameter: 255 mm
• Height: 337 mm
• Capacity: 10 L
• Diameter Inner Neck: 48mm

Specifications:

• Autoclavable: Not Autoclavable
• Certifications/Compliance: USP Class VI, non-cytotoxic, USP <661>, non-pyrogenic, FDA 21 CFR 177.1520
• Closure Included: Yes
• Closure Material: Silicone-lined Polypropylene
• Graduated: Yes
• Mouth: Narrow
• Shape: Square
• Color: Blue-Green
• Material: Polycarbonate
• Sterility: Sterile
• Type: Biotainer Bottles and Carboy
• Closure Color: White

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