Nalgene® 383120-42 Certified Clean Polycarbonate Biotainer Bottles, Low Particulate, 1 Liter, case/35

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: 166 mm
• Capacity: 1 L

Specifications:

• Certifications/Compliance: USP 788
• Closure Included: Yes
• Graduated: Yes
• Shape: Square
• Material: Polycarbonate
• Sterility: Sterile
• Type: Biotainer Carboy

Documents