Nalgene™ Certified Platinum Clean HDPE Bottles and Carboys
Maintain product integrity with certified ultra clean HDPE bottles and carboys. Designed to contain below 1/3 of the allowable particulate matter limits specified in USP <788>.
Brand: Thermo Scientific Nalgene CE-N2199-0032
Additional Details : Weight : 0.03920kg
- 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
|Nalgene Certified Platinum Clean 1L Widemouth HDPE Bottle Sterile, < 1/3 USP <788> Particulate Compliant|
|< 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21CFR 177.1318|