Reduction of bacterial endotoxin
Depyrogenated RTU components address the needs of the parenteral market, by ensuring the delivery of endotoxin free components meeting USP <85> and EP 2.6.14 reduction of pyrogenic substances, including bacterial endotoxin standards to achieve endotoxin levels meeting acceptable limits. Minimizing time-consuming upstream processing steps required of Pharmaceutical Drug Manufacturers.
Parenteral drug products must be manufactured to strict sterility guidelines using well documented and validated aseptic processes. To meet this need, DWK provides our Customers with glass vials prepared using validated processes that ensure the removal of bacterial endotoxins to acceptable endotoxin limits (0.25 EU/ml) . Each glass vial is subjected to high dry heat treatment to destroy pyrogens and vacuum packaged within an ISO clean room environment for terminal sterilization.
- Dry Heat Depyrogenation: Components meet USP <85> / EP 2.6.14 Reduction of pyrogenic substances, including bacterial endotoxin and are ready-to-sterilize.
- Quality Assurance and Traceability: All products come with full documentation and certification to meet regulatory requirements.
- Flexible Solutions: Small to large volume processing and custom packing of glass containers.
- Operational Efficiency: Eliminate internal processing and validation steps to reduce cost and improve workflows.
- Clear and amber Type I USP <660> tubular glass vials designed for the short and long term storage of parenteral, lyophilized, and vaccine content. Available in ISO 8362-1 and RTU sterile glass vial formats.
- Clear and amber Type I threaded glass vials with freeze dried bases suitable for lyophilization applications and the packaging of diagnostic assays and reagents. Available in RTU sterile glass vial formats.
- Clear and amber Type I threaded and crimp finish glass vials designed for maximum retrieval of high value biologic, volatile solvent, corrosive chemical and sensitive content. Available in RTU sterile glass vial formats.
- Type I Borosilicate Clear & Amber and Soda Type III glass vials suitable for use with Snap Caps, Tamper Proof Closures, and Nasal Spray Pump Systems. Available in RTU sterile glass vial formats.