The closed vial technology is based on a vial that is provided clean and sterile with the stopper in place. Thanks to such container design, the most complex filling steps of classical open vials, such as vial washing, stopper washing, and hot air tunnel sterilization, are eliminated. The filling is done by means of a needle that pierces the stopper and dispenses the liquid. After needle withdrawal, the puncture trace is immediately resealed with a laser to restore closure integrity.
Three major advantages can be identified with the closed vial technology compared with usual technologies using glass vials.
Better Sterility Assurance and Reduced Particle Presence
Most important is an increase in quality for the patient, observed for both sterility assurance level and particle presence.
A higher sterility assurance level is obtained by keeping the vial always closed; therefore, there is no risk of contaminant penetration inside the vial due to environmental exposure. Glass vials are frequently exposed for more than 20 minutes between the sterilization tunnel and the stoppering station under HEPA filters whereas such exposure is eliminated with the closed vial technology. Another advantage for the patient is obtained using a newly designed capping technology. The entire stopper surface is protected by a circular rib, located on the inner face of the cap, which creates additional closure integrity.
Simplified Filling Operations
The second advantage is a simplification of the filling operation. Glass filling equipment becomes obsolete with the closed vial technology:
- The washing stations for both vial bodies and stoppers are unnecessary.
- As a consequence of the lack of washing, there is no need for water for injection on the filling line, eliminating a major source of expense, validation work, and risk of batch reject.
- The sterilization tunnel with its high consumption of energy and difficulties for validation is also eliminated.
- The stoppering station, a source of frequent short stops, is also eliminated
- The capping station, using simple snap fit technology, is simplified compared with the crimping process used for aluminum caps.
Secured Supply Chain and Easier Handling
The third advantage is linked to the design of the vial to improve the supply chain until injection of the product. First, by the use of COC, the vial body is resistant to shocks and cannot be easily broken, conferring a higher safety assurance for the operators but also for the practitioners and the nurses, especially when potent or radioactive products are used. In addition, for end users, the stopper was designed to have a large and flexible piercing area and to favor the complete collection of the liquid by avoiding recess areas, significantly reducing expensive overfill.
From: “A New Technology For Aseptic Filling of Injectable Drugs”