Description
Unit Size: Case of 1
• 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^-6inside 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
