Meeting the critical packaging standards for pharma and diagnostic applications
DWK Life Sciences vial manufacturing produces tubular glass vials from the highest quality raw materials under the most stringent manufacturing controls to produce glass primary packaging meeting United States (USP), European (EP), and Japanese (JP) compendial standards. Each of our manufacturing entities utilize identical equipment, feed stock, manufacturing processes, quality controls, and inspections to meet customer requirements at all of their geographic operations.
Using state-of-the-art glass robotic handling, forming, annealing, and camera inspection equipment and processes, DWK’s global manufacturing sites consistently deliver vials having excellent dimensional tolerance, chemical resistance, and cosmetic appearance. Each vial is camera inspected and robotically packaged in an ISO 8 corrugate free cleanroom environment to ensure tubular glass vials are delivered free from defects and human bioburden.
Through our ISO 15378 accredited manufacturing sites, each clear and amber tubular glass vial conforms to the standards for primary packaging containers for medicinal applications and the ISO 8362 standard for injectable preparations. Making them ideally suited for the storage of vaccines and other biologics.
As your trusted partner, you can rely on DWK Life Sciences to simplify sourcing and support you at each stage of your drug development life cycle. Rely on DWK to provide product and process details, including Device Master File (DMF) support. From small quantity primary package evaluations to moderate quantity validations through large quantity production, our tubular glass vials are available in a range of color, capacity, ISO & GPI finish, blowback, secondary packaging, and custom configurations.
Vials can be surface treatment to improve hydrophobicity or particulate cleaned and sterilized to meet your ready-to-sterilize (RTS) and ready-to-use (RTU) workflows.
- ISO 15378 Specifies requirements for a quality management system applicable to primary packaging materials for medicinal products.
- USP <660>, EP 3.2.1, JP 7.01 Compendial Standards Defines the performance of glass containers used in pharmaceutical packaging/delivery systems for various parenteral and non-parenteral preparations.
- ISO 14644-1 Details the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and controlled environments. DWK vials are packed in ISO class 8 clean rooms undergoing continuous monitoring in accordance to DIN EN ISO 14644-1.
- ISO 8362-1 Specifies the form, dimensions and capacities of glass vials for injectable preparations including the material and associated performance requirements.
- ISO 11418-7 Specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations.
- Quality Controls We deliver products meeting dimensional, cosmetic, chemical, temperature, and cleanliness standards.