USP Class VI, non-cytotoxic, USP <661>, non-pyrogenic, FDA 21 CFR 177.1520
Closure Included
Yes
Autoclavable
Not Autoclavable
Graduated
Yes
Mouth
Narrow
Shape
Square
Height (Metric)
493 mm
Product Type
Biotainer Bottles and Carboy
Height (English)
19.4 in.
Closure Material
Polypropylene
Closure Size
48 mm
Diameter (Metric)
255 mm
Unit Size
Case of 3
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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
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
* Studies are non-GMP and provided for informational purposes only. The identify and quantity of extractables may vary with routine changes made to the manufacturing process. Our The studies may assist you in determining whether further leachable studies are warranted to meet any applicable regulatory requirements or expectations, and are available under CDA by contacting us at rocregsupport@thermofisher.com
**The term leakproof applies to Thermo Scientific Nalgene products that meet the following criteria: a) Bottle/flask/funnel closure systems with closures smaller than 100 mm, after they are filled with water, inverted, withstand air pressure of 2 psig for 2 minutes, and no water escapes;. b) Bottle/funnel/flask closure systems of larger than 100 mm after they are filled with water, inverted for 15 minutes, and no water escapes.
Note: these tests, using other liquids, may not yield the same results. To ensure safe usage, customers are advised to test Thermo Scientific Nalgene bottles and closures under conditions of their planned applications. Thermo Scientific Nalgene products are leakproof at ambient temperature and pressure when used with their Nalgene closures.