Closure of a vial is an important packaging parameter for parenteral drugs. For every injectable solution on the market, countless hours are spent by the pharmaceutical industry to make sure that they are essentially free of particulate contamination.
Closures for parenteral vials
The primary component for the closure is an elastomeric rubber stopper. These typically come in a range of types and shapes;
- Large volume parenteral stoppers
- Ready-to-sterilize / Ready-for-Sterilization RTS and ready-to-use RTU or sterile formats
- Lyophilization stoppers (igloo, two-legs, three leg and even four)
- Serum stoppers
- Film coated stoppers with barrier film
Meeting pharmaceutical regulations
As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the container closure system.
Rubber closures are an essential packaging for parenteral drug products, and they can be a source of particulate matter.
Contamination and imperfections associated with elastomer components are a source of risk, especially for areas that are not visible when the component is positioned in the container. Possible causes for end-of-line rejects are loose and embedded particles and defects caused by trimming and molding.
Reducing end-of-line rejects
Top-of-the-range pharmaceutical vial closures are 100% automatically vision verified and free of visible defects and contamination. This reduces end-of-line rejects and enhances product quality and patient safety.
The machine vision systems provide imaging-based automatic inspection and analysis for such applications as automatic inspection and process control. Cameras are used to capture the image data from the examined closure.
100% vision inspection can detect “visible” defects even when less than 100 um in size. The high-end systems available can even detect invisible defects, like metal particles that are embedded in the elastomeric rubber material of the closure.