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.

Product Code	Brand	Capacity (Metric)	Product Type	Mouth
16470601	Thermo Scientific™ CE-E2099-0001	30 mL	Media Storage Bottle	Narrow
16470611	Thermo Scientific™ CE-N2099-0008	250 mL	Media Storage Bottle	Narrow
16400621	Thermo Scientific™ CE-N2199-0008	250 mL	Media Storage Bottle	Wide
15625935	Thermo Scientific™ CE-N2199-0016x	500 mL	Media Storage Bottle	Wide
16490611	Thermo Scientific™ CE-N2099-0032	1 L	Media Storage Bottle	Narrow
16420621	Thermo Scientific™ CE-N2199-0032	1 L	Media Storage Bottle	Wide
15645935	Thermo Scientific™ CE-N2289-0020x	10 L	Carboy	Narrow
16450621	Thermo Scientific™ CE-N2289-0020	10 L	Carboy	Narrow
16460621	Thermo Scientific™ CE-N2289-0050	20 L	Carboy	Narrow
16470621	Thermo Scientific™ CE-N2289-0075	33 L	Carboy	Narrow

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

• For Use With (Application): Media/Buffer Preparation ​, Media/Buffer Storage, Sampling, Storage, Transportation ​, Validation Testing, Drug Substance, Drug Product
• Sterility: Sterile
• Low Particulate: <1/3 USP <788> (Ultralow particulate)
• Closure Included: Yes
• Shape: Round

• Material: HDPE
• Temperature Range (Metric): -100°C to 120°C
• Certifications/Compliance: < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21 CFR 177.1315
• Autoclavable: Not Autoclavable
• Closure Material: Polypropylene

*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.