PremiumFill®

Prefilled Syringe Components, Vial Components

Pharma

PremiumFill® is a guaranteed specification, resulting in lower embedded particles, improved particulate integrity and an overall reduction in defects. PremiumFill® , from Aptar Pharma, ensures high compatibility with highly sensitive drugs, to help protect them throughout their shelf life.

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Ensuring a Higher Level of Protection for Sensitive Drugs

Delivering the highest levels of quality to meet increasing requirements

The Premium offering is designed to deliver cleaner components to our customers, taking our commitment to improving quality to even greater levels of reassurance. One of the core elements of our Premium portfolio, PremiumFill® is our guaranteed specification for our highest production standards. PremiumFill® further reduces risks related to particles and defects, and is the top quality specification to answer the highest customer requirements.

State-of-the art production processes

All our manufacturing is done in-line, which lowers the risk of contamination during transport around the plant and avoids adding intermediate storage steps in a classified manufacturing area. Our PremiumFill® process is conducted within cleanroom conditions. Molding, trimming, and washing are conducted in an ISO 7 environment and finishing is conducted in an ISO 6 environment, providing further quality assurance to our customers. By simplifying every stage of the process, by reducing human contact, we mitigate against risk of errors and improve the quality and integrity of our end product.

Premium quality offering, to accelerate and derisk your drug product development

PremiumFill® achieves lower embedded particles, significantly improves particulate cleanliness (in size and quantity) and provides a tighter specification on critical molding defects, granting an overall improvement of quality level. PremiumFill® is available for both vial stoppers and for Pre-Filled Syringe (PFS) components. This added-value process ensures high compatibility with highly sensitive drugs, protecting them throughout their shelf life.

Pure state-of-the art formulations

Aptar Pharma’s proprietary elastomeric formulations are designed and manufactured to provide the highest level of quality and safety for our injectable components. We offer a variety of elastomeric formulations providing optimized self-sealing and resistance to coring, combined with high chemical inertness, which is essential for your drug products. Most of our elastomeric formulations can be provided with PremiumFill® specification, enhancing overall components quality and cleanliness.

PremiumFill® Advantages

Overall Reduction in Defects
Improved Particulate Index
Improved Cleanliness

Low level human interaction mitigates risks

PremiumFill® mitigates against risk of errors, and improves quality and integrity of our end product.

In-line manufacturing reduces contamination risks

Our in-line manufacturing process lowers the risk of contamination between each manufacturing step, avoiding intermediate storage, reducing human contact and handling.

Cleanroom manufacturing and specific gowning improves cleanliness

Molding, trimming, and washing in an ISO 7 environment and finishing in an ISO 6 environment guarantee improved component cleanliness.

We apply strict gowning procedures for operators in order to limit contamination in the cleanroom, and carefully select adapted gowns granting the lowest level of contamination during the manufacturing process.