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Thermo Scientific™ Nalgene™ HDPE Platinum Certified Clean Bottles and Carboys

Thermo Scientific™ Nalgene™ HDPE Platinum Certified Clean Bottles and Carboys are certified platinum clean and include particulate certifications to under 1/3 the allowable limits according to USP<788> and lower endotoxin levels of 0.25 EU/mL, to help mitigate potential sources of unwanted impurities.

14200.00 SEK - 85035.00 SEK

Specifications

For Use With (Application) Media/Buffer Preparation ​, Media/Buffer Storage, Sampling, Storage, Transportation ​, Validation Testing, Drug Substance, Drug Product
Material HDPE
Sterility Sterile
Temperature Range (Metric) -100°C to 120°C
Low Particulate <1/3 USP <788> (Ultralow particulate)
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Products 9
Product Code Brand Capacity (Metric) Product Type Mouth Price Quantity & Availability  
Product Code Brand Capacity (Metric) Product Type Mouth Price Quantity & Availability  
16470601
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Thermo Scientific™
CE-E2099-0001
30 mL Media Storage Bottle Narrow
85035.00 SEK
Pack of 72
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16470611
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Thermo Scientific™
CE-N2099-0008
250 mL Media Storage Bottle Narrow
40945.00 SEK
Pack of 72
In Stock
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16400621
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Thermo Scientific™
CE-N2199-0008
250 mL Media Storage Bottle Wide
61140.00 SEK
Pack of 72
Estimated Shipment: 03-06-2025
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16490611
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Thermo Scientific™
CE-N2099-0032
1 L Media Storage Bottle Narrow
20510.00 SEK
Pack of 24
In Stock
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16420621
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Thermo Scientific™
CE-N2199-0032
1 L Media Storage Bottle Wide
30750.00 SEK
Pack of 24
Estimated Shipment: 12-05-2025
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15645935
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Thermo Scientific™
CE-N2289-0020x
10 L Carboy Narrow
30005.00 SEK
Pack of 6
Estimated Shipment: 07-07-2025
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16450621
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Thermo Scientific™
CE-N2289-0020
10 L Carboy Narrow
33725.00 SEK
Pack of 6
Estimated Shipment: 09-12-2024
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16460621
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Thermo Scientific™
CE-N2289-0050
20 L Carboy Narrow
31485.00 SEK
Pack of 4
In Stock
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16470621
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Thermo Scientific™
CE-N2289-0075
33 L Carboy Narrow
14200.00 SEK
Each
Estimated Shipment: 09-12-2024
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Description

Description

Our single-use products, including Thermo Scientific™ Nalgene™ HDPE Platinum Certified Clean Bottles and Carboys, help reduce the potential for carry-over contamination. Our new certified platinum clean products include particulate certifications to under 1/3 the allowable limits according to USP<788> and lower endotoxin levels of 0.25 EU/mL, to help mitigate potential sources of unwanted impurities.

  • Products are washed with USP Water for Injection and handled post-washing in Class 5 clean rooms with Class 4 packaging/inspection hoods to produce these very low particulate products
  • Certified and lot-to-lot tested to contain less than 1/3 the particulates allowable according to USP <788> to limit potential particulate contamination
  • Certified low endotoxin (0.25 EU/mL) according to USP <85> to reduce pyrogens
  • Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the container/closure, including 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
  • All container/closure systems are certified leakproof* to protect valuable contents
  • Robust, HDPE can be used from -100°C to 120°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.
  • Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications
  • 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
Specifications

Specifications

Media/Buffer Preparation ​, Media/Buffer Storage, Sampling, Storage, Transportation ​, Validation Testing, Drug Substance, Drug Product
Sterile
<1/3 USP <788> (Ultralow particulate)
Yes
Round
HDPE
-100°C to 120°C
< 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21 CFR 177.1315
Not Autoclavable
Polypropylene
Videos
SDS
Documents

Documents

Product Certifications

*Our guarantee for a leakproof seal is subject to our standard product warranty, as set forth in the Thermo Fisher Scientific Terms and Conditions of Sale. Our products are leakproof at ambient temperature and pressure when used with their corresponding closures. However, to ensure safe usage, customers are advised to test our containers and closures under conditions of their planned applications. Please contact technicalsupport@thermofisher.com if you need additional information about our products.

**Forced extraction studies and validation binders from Thermo Fisher Scientific, where available, are provided under a confidentiality agreement to assist customers in product selection. Customers are responsible for determining what studies are recommended for its specific applications. Forced extraction studies and validation binders may be requested by contacting us at ROCregSupport@thermofisher.com.