Description

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 0.25EU/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

Specifications:

Height (English): 2.4 in.
Height (Metric): 61 mm
Product Type: Bottle
Capacity (Metric): 30 mL
Capacity (English): 1 oz.
Color: Colorless
Description: Nalgene Certified Platinum Clean 30mL HDPE Bottle, Sterile, < 1/3 USP <788> Particulate Compliant
Material: HDPE
Sterility: Sterile
Certifications/Compliance: < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1324
Closure Included: Yes
Autoclavable: Not Autoclavable
Closure Size: 20 mm
Closure Material: Polypropylene
Diameter (Metric): 34.3 mm
Mouth: Narrow
Shape: Round