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Platform of Vial Stoppers for Liquid and Lyophilized Drugs

 

Patient receiving an injection

How can decades of expertise support your drug development and help guarantee your patient’s safety?

Leveraging over 50 years of expertise in rubber formulation and manufacturing, Aptar Pharma’s full range of stoppers offers optimized chemical and functional properties to ensure your doses remain safe from the time of filling to patient delivery.

Aptar Pharma operator in a clean room for manufacturing Vial stoppers and limiting the risk of particulate or biological contamination

Our stoppers meet your most stringent needs

Our range of vial stoppers includes PremiumCoat® ETFE film-coated solutions for sensitive drugs, and PremiumFill® quality assurance for increasing your operational efficiency and patient safety.

All our stoppers are delivered Ready-to-Sterilize (RTS) or Ready-to-Use (RTU) with sterility guaranteed to improve your operational efficiency. Our solutions can be packaged in standard bags or in a variety of Rapid Transfer Port bags for direct connection to your isolators.

Vial stoppers manufactured in a clean room with advanced robotization to ensure quality and limit the risk of particulate contamination

Our capacity expansion secures your supply and quality

We are increasing our production capacity in both France and the United States to support growing Pharmaceutical needs and to ensure our customers’ supply is secure. We implement robotization in our cells, digitalize our processes and partner with you to guarantee your project’s success.

At Aptar Pharma, we are transforming the expectations of what an injectables partner can be.

Aptar Pharma Stoppers & PremiumCoat® Solutions

 

  • Vial Stoppers

  • Lyophilization Stoppers

  • PremiumCoat®

  • Aptar Pharma stoppers leverage state-of-the-art pure formulations and proprietary design to guarantee chemical and functional performance

    Solutions for single dose, multidose and intravenous delivery

    Our vial stoppers leverage our state-of-the-art Bromobutyl for low extractables & leachables, and our Chlorobutyl for non-buffered/acidic drugs, to ensure compatibility with the drug throughout its lifecycle.

    Our stoppers are compatible with ISO vials, with either Non-Blowback or European Blowback-specific designs.

  • Aptar Pharma stoppers leverage state-of-the-art pure formulations and proprietary design to guarantee chemical and functional performance on lyophilization lines

    Ensuring long-term integrity for lyophilized drugs

    Our market-proven Bromobutyl offers low residual moisture and minimized water permeation to protect the integrity of lyophilized drugs.

    Our two-legged and igloo designs are combined with preplacement features and rough surface treatments to facilitate the lyophilization process, and to limit the risk of sticking on lyophilization shelves.

  • Aptar Pharma PremiumCoat® ETFE film-coated stoppers leverage state-of-the-art pure formulations to minimize the risks linked to Extractables and leachables

    Premium protection for your most sensitive drugs

    Our PremiumCoat® platform combines our pure Bromobutyl formulation with our market-proven ETFE film-coating and state-of-the-art finishing process to guarantee our lowest level of extractables & leachables, and optimal particulate cleanliness.

    The proven functional properties of PremiumCoat® help ensure the drug remains protected from drug filling through to patient administration.

Vial Stoppers for Biotech Drugs, Vaccines and Small Molecule Delivery

 

Aptar Pharma vial rubber stopper being manufactured in a clean room to limit the risk of particulate and biological contamination. Aptar Pharma vial rubber stopper being manufactured in a clean room to limit the risk of particulate and biological contamination. Aptar Pharma vial rubber stopper being manufactured in a clean room to limit the risk of particulate and biological contamination.
  • Biologic Drug Delivery

    Our pure Bromobutyl formulation and PremiumCoat® ETFE film-coated stoppers protect sensitive drugs from extractables & leachables, and are ideal solutions for anticipating vial-to-prefilled (V2P) lifecycle management strategies.

    The functional performance of our formulation combined with our versatile designs ensure that the drug remains safe from the time of filling to patient administration.

  • Single Dose and Multidose Vaccines

    Our versatile, market-leading, Bromobutyl formulation, can be combined with our PremiumCoat® ETFE film coating to protect the most sensitive vaccines. Its functional performance enables multi-piercing, supporting safe vaccination campaigns.

    Our Chlorobutyl formulation, trusted on the market for over 20 years, limits the generation of particles on high-speed filling lines.

  • Small Molecules and Generic Delivery

    Our Halobutyl formulations offer a versatile panel of solutions that can accommodate aggressive solvents, unbuffered solutions and acidic drug formulations.

    Our designs and surface treatments enable high-speed filling and promote efficiency during lyophilization cycles.

    With our large production capacity, we secure long-term supply to derisk your projects and ensure patients safely receive their critical doses.

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Supporting Your Drug Development Needs With Data, Service Packages and Beyond

At Aptar Pharma, we understand the importance of supporting you, our Pharma partners, as you choose and validate your packaging components.

PremiumCoat® Data Packages provide you with all the information, test data and analysis you will need to understand our solution’s performance and help you make a fact-based decision when choosing PremiumCoat®. These data packages include glass container compatibility data (ie. Container Closure Integrity testing, pop-off testing…), simulation studies to help anticipate potential issues linked to leachables, and the full extractable file for regulatory submission.

PremiumCoat® Service Packages leverage the capabilities of our Aptar Pharma Service Companies, providing end-to-end support for your drug development process and validating your choice of primary packaging for your drug.

Aptar Pharma and our service companies can also support your specific development needs:

  • Aptar Pharma Services: Device development, project management support and any customizations that you may need
  • Gateway analytical: Analytical services, Extractable & Leachable tests, CCIT testing, particulate detection and more
  • Noble: Human factors studies, adherence programs and patient onboarding programs

Although our solutions are designed to be versatile, we understand that each project may require a tailor-made approach. In these instances, Aptar Pharma’s experts can help you evaluate your needs, and design customized components and services that will ensure your success.

Our Versatile Platform of Products

Leveraging the 6720GC Bromobutyl formulation and market-proven ETFE film, our PremiumCoat® vial stoppers are available in 13mm and 20mm diameters. Their compatibility with Non-Blowback vials was demonstrated, ensuring long term Container Closure Integrity and resistance to pop-off on filling lines.

 

Our stoppers are available in Bromobutyl (6720GC) and Chlorobutyl (6422GS) formulations.

Our specific designs for Non-Blowback or European Blowback are compatible with ISO vials.

Our stoppers are available in Bromobutyl (6720GC) and Chlorobutyl (6422GS) formulations.

Our designs are compatible with ISO8362-2 and DIN58363 standards.

Bromobutyl formulation with low residual moisture and low permeability to water.

Our two-legged and igloo designs include specific features to facilitate preplacement of the stopper on the vial and to facilitate full dose recovery.

Versatility and Performance with Aptar Pharma’s Vial Containment Solutions

Contact Aptar Pharma’s expert team today to learn more about our platform of vial containment solutions to support your drug development.

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