Nalgene™ Certified Clean Polycarbonate Biotainer™ Carboys

Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the bottle/closure Robust, PC can be used from -100ËšC to 100ËšC, 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 All container/closure systems are certified leakproof** to protect valuable contents 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 Additionally our certified clean products include: Clean room produced in ISO Class 7 to limit particulates during molding 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 Certified and lot-to-lot tested to meet USP <788> low particulate requirements to limit potential particulate contamination Certified low endotoxin (0.50 EU/mL) according to USP <85> to reduce pyrogens