PremiumCoat®
Vial Components
Pharma
Aptar Pharma’s PremiumCoat® is a range of ETFE (Ethylene Tetrafluoroethylene) coated stoppers and plungers based on an approved, pure, state-of-the-art elastomeric formulation. Providing a combination of container closure integrity and improved compatibility, PremiumCoat® offers the highest standard level of guaranteed specification of particulates to protect your sensitive drugs.
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Premium Film-Coated Components, for Unrivaled Particulate Reduction
Delivering the highest levels of quality to meet increasing requirements
Our experience and expertise combined with our ongoing commitment to quality enables us to deliver premium solutions to your injectable challenges, reducing the risk of contamination and compatibility issues.
As the pharmaceutical and biotech markets continue to develop more sensitive drugs including complex proteins, there is an increased need for more inert injectable components. Our PremiumCoat® range of coated stoppers and plungers are covered with a fluorinated (ETFE) film, which is applied during the manufacturing process. This approach delivers a homogenized protective coating, which is the established best practice method to create the most robust and effective barrier between the drug and the component.
Our PremiumCoat® range of components are compatible with most of the current primary packaging as well as being customizable, to best meet your requirements and support your specific developments.
PremiumCoat® significantly reduces the quantity of leachables long-term
The combination of a pure, state-of the art formulation and film coating offers an optimized compatibility between the component and the drug to reach an optimum chemical inertness. Studies have demonstrated the long-term benefits and performance of Aptar Pharma’s PremiumCoat™ components in multiple testing conditions including the utilization of various solvents and sterilization methods, all of which can improve your final product’s shelf-life.
Utilizes our pure, state-of-the-art elastomeric formulation
The reliable sourcing of carefully selected ingredients combined with development and state-of-the-art production of the most suitable and purest elastomer formulations for pharmaceutical use are key.
Our proprietary, pure and ultra-clean elastomeric formulations offer the lowest levels of extractables and leachables (E&L), setting the standard for injectable components.
Thanks to our in-house expertise, we continue to develop innovative formulations offering a balance of both mechanical and physical properties. We use the fewest possible ingredients, ensuring the best results in terms of chemical inertness, which is ideal for your sensitive drugs.
Lower PCI, for optimal protection of your sensitive drugs
Our PremiumCoat® components offer customers an unrivaled reduction in particulates. Thanks to our combination of pure elastomeric formulation and ETFE film coating, our PremiumCoat® components achieve a market-leading 1.3 Particulate Count Index (PCI), offering optimal cleanliness for your sensitive drugs.
Best-in-class quality to de-risk drug product development
Thanks to enhanced compatibility and tight particulate specifications, PremiumCoat® facilitates and reduces the risk of your project developments. PremiumCoat™ offers premium quality with our highest levels of cleanliness, including visual inspection of all of our components.
PremiumCoat® can also be offered Ready-to-Sterilize and Ready-to-Use (Sterile Gamma irradiated).
PremiumCoat® is available in various packaging formats for sterilization on-site or by direct introduction into isolators and Restricted Access Barrier Systems (RABS).
PremiumCoat® Advantages
- Reduces Extractables and Leachables
- Premium Purity
- High Compatibility
- Protects Sensitive Drugs
PremiumCoat® significantly reduces the quantity of extractables and leachables
Studies have demonstrated the benefits and performance of Aptar Pharma’s PremiumCoat® components. Proven effective in multiple testing conditions including the utilization of various solvents and sterilization methods, PremiumCoat® significantly reduces the quantity of extractables and leachables needed to protect your sensitive drug product.
PremiumCoat® achieves a market-leading PCI of 1.3
The market leading Particle Count Index (PCI) of PremiumCoat® provides a higher guarantee for safety and cleanliness of your final packaged drug.
Highly compatible with primary packaging
PremiumCoat® film-coated components provide a higher level of container closure integrity with most primary packaging available, giving you the perfect match of components for maximum compatibility, reliability and seal. Also offering optimized functional performance, PremiumCoat® helps further reduce risks associated with your drug product development.
Combining pure elastomeric formulation with ETFE film coating
Our proprietary, pure and ultra-clean elastomeric formulation combined with a proven ETFE (Ethylene Tetra-Fluoro-Ethylene) film coating offers a high level of chemical inertness suitable for the stability of highly sensitive drug products including Biotechs.
Find Out How PremiumCoat® Can Deliver Higher Quality For You
Contact one of Aptar Pharma’s experts to find out how PremiumCoat® can help further protect your sensitive drugs.
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