Description
Capacity (Metric): 10 L
Shape: Square
Certifications/Compliance: USP Class VI, Non-cytotoxic, USP <661>, Non-pyrogenic, FDA 21 CFR 177.1520
Temperature Range (Metric): -100°C to 100°C
Unit Size: Case of 2
• 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^-6inside the bottle/closure
• Robust, PC can be used from -100°C to 100°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
• 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 supportAdditionally 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
