Inconsistent packaging component quality can be the bane of drug manufacturing. Filling line performance can suffer because of components with inconsistent dimensions. End-of-line reject rates can be unacceptable because particles from components can contaminate finished drug product.

A drug manufacturer’s ability to meet regulatory requirements is driven in part by component quality. With Quality by Design initiatives, packaging component quality is increasingly important for manufacturing and processing drugs efficiently and problem-free.

The NovaPure Solution

NovaPure components provide a solution for a number of pharmaceutical industry quality challenges. NovaPure components help customers meet current quality requirements for finished pharmaceuticals and achieve consistent specifications for subvisible particles in finished drug products. NovaPure components are manufactured to uniformly high quality levels with a subvisible particle specification and a product-specific parts per million critical defects specification. Components are delivered with full documentation, including a formulation extractable profile to assure closure consistency of the highest level.

NovaPure components deliver measurable economic value. With NovaPure components, you can:

• Minimize the risk of extractables in the drug solution because NovaPure components are manufactured with West FluroTec^®  film.
  
  
• Eliminate silicone oil as a source of contamination because West FluroTec film improves performance in filling lines and in lyophilization chambers.
  
  
• Reduce or eliminate expense and exposure to regulatory risk associated with component preparation and sterilization because NovaPure components are delivered as Westar^® ready-to-sterilize or ready-to-use products.
  
  
• Reduce end-of-line rejections of filled product because each NovaPure component is vision-inspected for visible contamination and some dimensional tolerances.
  
  
• Have confidence that the composition of the closures, and the manufacturing processes, are uniform from laboratory-scale studies through commercialization because NovaPure components are certified by West’s VeriSure^® process.

Component Quality…by Design

Packaging components can mitigate the risks associated with injectable drug manufacturing. NovaPure components deliver the ultimate in component value and quality…by design.

FluroTec^® technology is licensed from Daikyo Seiko, Ltd.