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Thermo Scientific™ Nalgene™ Certified Clean Polycarbonate Biotainer™ Carboys

Specifically designed for pharmaceutical and biological manufacturing to reduce the risk of carry-over contamination. Durable, translucent PC construction ensures the integrity of your sample, even frozen to -100°C. 

Manufacturer:  Thermo Scientific™ 38341008

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Catalog No. 03-313-114


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Description

Description

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

  • 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 and two heat-sealed sterile barriers to protect product prior to use
  • All 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 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
  • Products can be supplied with forced extraction studies*, validation binders* and certificates
  • Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications
  • Clean roomproduced in ISO Class 7 to limit particulates during molding 
  • All container/closure systems are certified leakproof** to protect valuable contents
  • Robust, PC can be used from -100˚C to 100˚C, allowing for both heated mixing and frozen storage or shipment. Must be tested in actual use conditions as results may vary depending upon application.
  • Customer support includes our highly experienced commercial specialist teams, regulatory team, quality team and regional technical support
Specifications

Specifications

10L
Silicone-lined polypropylene
48mm
2
Sterile
White
255mm
Narrow
USP Class VI, non-cytotoxic, USP <661>, non-pyrogenic, FDA 21 CFR 177.1520
Blue-Green
Polycarbonate
1
No
48mm
337mm
Square w/PE handle
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* 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.