Description
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): 7.8 in.
- Height (Metric): 199.2 mm
- Product Type: Bottle
- Capacity (Metric): 1 L
- Capacity (English): 33.8 oz.
- Color: Colorless
- Description: Nalgene Certified Platinum Clean 1L Widemouth 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 177.1318
- Closure Included: Yes
- Autoclavable: Not Autoclavable
- Closure Size: 63 mm
- Closure Material: Polypropylene
- Diameter (Metric): 91.4 mm
- Mouth: Wide
- Shape: Round
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