Materials
- Our vial stoppers are composed of a latex- and rubber-free chlorobutyl formulation
- Sterile empty vials (SEVs) are aseptically assembled using sterile components, including glass and stoppers, to ensure final product sterility
- Some of our SEVs come equipped with FluroTec®—an extra barrier against extractables and leachables that minimizes the risk of impurities, interactions, and medicine degradation
Assembly
- Assembled in a Class 100 cleanroom environment in the United States
- All equipment undergoes regularly scheduled calibration, maintenance, validation, testing, measuring, and utilization procedures
Quality
- We strictly adhere to the FDA’s Current Good Manufacturing Practices (cGMPs) regulations, mitigating the potential for contamination that could impact the integrity of patients’ therapies
- These regulations tightly govern design, monitoring, and control of manufacturing processes and facilities
- Our SEVs are all assembled, sterilized, and tested at our plant in the United States and adhere to United States Pharmacopeia (USP) requirements
- All SEVs are eligible to be sold internationally
Our staff is continually trained in all aspects of cGMPs, Good Laboratory Practice (GLP), and quality assurance to ensure unfailing expertise in creating the vials we offer.
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