The quality and the compatibility of primary packaging components that are in contact with the drug product are essential to the stability and the performance of the drug product. In addition, elastomeric components are critical parts of container closure systems. The reliable sourcing of carefully selected ingredients and the development and state-of-the-art manufacturing of the most suitable and purest formulations dedicated to pharma use are key.
At Aptar Pharma, the research, development and manufacture of elastomeric formulations are in house and take place in dedicated expert centers. It allows us to fulfill the increasingly demanding needs of all our customers while satisfying the highest industry standards and regulatory requirements. This integrated strategy is the corner stone of our repeatable premium quality from batch-to-batch and security-of-supply to all our customers.
This service is available for the following delivery routes :
- Novel, cleaner and more inert elastomeric materials (Halobutyls, Nitriles, EPDMs, COCe, TPEs…)
- Improvements to existing formulations
- Surface treatments to render gaskets more inert and easier to process
- Development and validation of testing and analytical methods
Aptar Pharma is the pioneer in ready-to-sterilize elastomeric components and sterile stoppers used for injectables as well as home of pre-filled syringe components.
- Pure and ultra clean formulations offering the lowest levels of extractables / leachables
- Coated stoppers and plungers for sensitive drugs and specific applications
- Low moisture content formulations for lyophilization stoppers