Drug integrity. Shelf life. Stability. Purity. Risk reduction. Container closure integrity. All are daunting challenges that keep you awake at night. Meeting these challenges keeps you in business.
The importance of parenteral packaging selection
Bringing an innovative and novel drug product to market requires years of work and an enormous amount of capital and intellectual investment. Along the way, many important decisions are made that can impact critical timelines. Among these decisions is choosing a suitable container and closure for your sensitive biotech drug product.
Drug integrity, stability, purity and efficacy can all be adversely affected if you select packaging components that are chemically not compatible with your drug product. West offers elastomeric formulations to meet the exacting requirements of unstable and sensitive biotech drug products.
To minimize drug interaction with stoppers and prefilled syringe plungers and help reduce the risk of drug contamination, West recommends components with a barrier film such as FluroTec®.
When considering a stopper or plunger, cleanliness goes beyond the make-up of the rubber formula. Issues with bioburden, endotoxin and particulate are critical factors in component preparation, which is why West offers Westar® RS (Ready-to-Sterilize) products.
Selecting the appropriate material for vials or prefilled syringes can help assure your drug product’s shelf life by minimizing container/drug interaction. To address multiple market needs, West offers thermoplastic cyclic polyolefin vials and prefilled syringes particularly attractive for oncology and extreme pH products.
A West Flip-Off® seal completes your package selection and helps mitigate the risks associated with failed container closure integrity, which can cause your drug product to lose efficacy and stability.
To help assure proper package selection and help avoid possible incompatibilities between drug product and container closure, West offers PakScreen™, a product screening analysis.