Dependably Meet Regulatory Requirements
Regulators expect drug manufacturers to consistently meet and demonstrate compliance with sterile manufacturing requirements intended to assure delivery of clean, sterile, and safe drug products into the medical marketplace.
DWK helps our Customers meet this goal by preparing sterile glass vials and RTU products under validated processes, within a clean room environment, and to strict quality assurance procedures. Assuring the delivery of certified RTU products conforming to the USP <71> / EP 2.6.1 standards defining acceptable Sterility Assurance Levels (SAL) of 10-6.
All sterile glass vials and RTU products are enclosed in vacuum-sealed sterile transport bags within a clean room to assure safe entry into your aseptic operation. RTU products come with full documentation and certification.
- Sterilization: We offer steam heat, gas and irradiation - the choice is yours!
- Quality Assurance and Traceability: All sterilized vials include full documentation and certification to meet regulatory requirements.
- Flexible Solutions: Small to large volume processing and custom secondary packing of sterile glass vials and plastic primary packaging components, closures, stoppers, and seals.
- 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.
- Suitable for lyophilization
- For piercing applications
- Eliminates the need for crimping
- Available in RTU formats.