DF30 Metered Dose Valve Platform for Pressurized Metered Dose Inhalers

Inhalers, Metered Dose Inhalers

Pharma

Aptar Pharma’s DF30 metering valve for asthma inhalers is the reliable proven standard for today’s pressurized metered-dose inhalers (pMDI). Refined over decades, it powers many of today’s blockbuster drugs for asthma and COPD, delivering medication safely and repeatably. Our proprietary technology underpins the exceptional performance with the widest range of pMDI formulations and is compatible with traditional hydrofluoralkane (HFA) propellants and the newer lower Global Warming Potential (GWP) propellants (HFA152a and HFO1234ze) for more sustainable pMDIs.

Aptar Pharma can meet your sustainable pMDI propellant filling needs.

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The Proven pMDI Metering Valve Technology

The gold standard pMDI metering valve

Our DF30 metering valve has been the proven industry standard for pressurized metered-dose inhalers (pMDIs) for more than 25 years. They power many inhalation drug products marketed worldwide for asthma and COPD. With constant improvements and optimizations, Aptar Pharma’s DF30 pMDI metering valves continue to set new standards through materials, design and support.
Aptar Pharma’s in-house pMDI valves and actuators work with a wide range of formulations and our integrated services offering can help accelerate and derisk your next OINDP product development.

Compliance & Compatibility

Our DF30 metering valve has been the proven industry standard for pressurized metered-dose inhalers (pMDIs) for more than 25 years. They power many inhalation drug products marketed worldwide for asthma and COPD. With constant improvements and optimizations, Aptar Pharma’s DF30 pMDI metering valves continue to set new standards through materials, design, and support.
Aptar Pharma’s in-house pMDI valves and actuators work with a wide range of formulations and our integrated services offering can help accelerate and derisk your next OINDP product development.

 

Robust Design, optimization and development for asthma inhalers

Aptar Pharma’s design and development team incorporates the DF30 metering valves that result in high-performance and reliability of asthma inhalers. We offer high-quality lab tested elastomeric options that provide both product integrity and compatibility over the life of the product. The robust metering valve design delivers accurate and consistent inhaled drug delivery to patients.

Sustainable inhaler devices

Aptar Pharma can meet your sustainable pMDI propellant filling needs as well as offer a range of reformulation services.
Our pressurized metered dose inhaler valves are manufactured using only regulatory-approved materials. All our devices are developed using a proprietary elastomer formulation and produced with our in-house manufacturing facilities. We manufacture our valves with the patient in mind and all of our products are calibrated to meet specific customer requirements.

Read our publication on sustainable inhalers

Watch our webinar on sustainable inhalers

The standard metering valve for asthma inhalers, DF30

Aptar Pharma’s DF30 metering valve represents proven quality in performance in pressurized metered-dose inhalers (pMDIs) drug delivery. The DF30 metering valve technology is incorporated into high-volume prescription drug products marketed worldwide for asthma and COPD. It is approved for use in major markets around the world including Asia, Europe, Latin America, and the U.S.A. With three high-quality metering valve manufacturing facilities located strategically in Europe and Asia, Aptar Pharma can provide security of supply to customers anywhere. Manufacturing sites are quality focused and maintain compliance with the increasingly stringent regulatory requirements of major regulatory bodies including the EMA, and U.S. FDA.

The DF30 metering valve line has undergone continuous improvements and  optimizations over decades to maintain its position as one of the most trusted and relied upon metering valve in the pMDI industry. We’ve achieved this through our dedication to R&D and commitment to sustainability. Compatible with traditional HFA propellants, the DF30 line of metering valves has been optimized to work seamlessly with other lower Global Warming Potential (GWP) propellant options, like P152a or 1234ze, thus reducing the environmental impact of our valves.

Aptar Pharma has strategic sustainability goals to meet across its operations and through its new product designs, which use Eco-Design tools and Quality by Design (QbD) principles to achieve them. The DF30 metering valve technology is the industry standard for pMDI applications.

Compliance & Compatibility

The regulatory success of our DF30 metering valve extends over three decades of continuous improvement. Supported by our experienced team of regulatory affairs experts, Aptar Pharma has supported 30 Drug Master Files (DMFs) and over 50 successful U.S. FDA New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

The DF30 metering valves are compatible with most standard pressurized metered-dose inhaler (pMDI) filling lines, including those using cold or pressure filling methods. This allows our customers to integrate our industry leading metering valves quickly and easily to their production facilities, getting inhalation products to patients on time. They are also suitable for both solution and suspension-based formulations with a range of innovative and robust gasket materials available to ensure compatibility.

Our DF30 metering valves are long recognized as fully optimized for HFA propellants. As the demand for lower Global Warming Potential (GWP) propellants has grown, Aptar Pharma’s R&D leaders have stayed ahead of the curve, upgrading the DF30 to remain compatible with newer, more environmentally friendly propellants such as P152a or 1234ze. Today’s DF30 metering valves provide the same reliable and consistent operational performance you’ve come to expect from Aptar Pharma but are adapted to advancing environmental objectives.

Integrated Support Services for OINDPs

All our metering valves for OINDPs are supported with comprehensive analytical, formulation and regulatory services and support to move our customer’s products to market. These complete services and support can help to derisk and accelerate the development process for new or generic pMDI products. Our regulatory support teams know the way to approval of pressurized metered dose inhaler products containing our DF30 metering valves. We can provide extractable and toxicology dossiers to support customer regulatory filings. Aptar Pharma are also formulation experts and can develop inhalable formulations that are optimized for use in our devices and metering valves. With in-house pilot filling equipment and off the shelf formulation development services we can streamline this complex development activity. Our specialized analytical laboratories can complete e extractable and leachable studies, perform bioburden, silicon oil assays as well as prepare full extractable and toxicology packages to support customer regulatory filings. We also analyze physical properties such as aerodynamic sizing and spray characteristics, as well as mechanical, stress and content uniformity and moisture content testing. We are specialists in developing pMDI products, so you don’t have to be.

DF30 Metering Valve Advantages

  • Excellent pressure filling performance
  • Ultra clean proprietary elastomers
  • Compatible with most pMDI formulation types
  • Backed by expert OINDP support
  • A robust supply chain

Our DF30 platform demonstrates excellent pressure filling performance across most pMDI filling technologies

Onsite support from a dedicated team of filling and crimping experts ensures a seamless transition from the laboratory through to commercial filling lines.

We develop and manufacture robust, proprietary ultra clean elastomers in our dedicated facilities

Ultra clean elastomeric materials minimize extractables and mitigate potential issues with leachables. Our in-house manufacture safeguards the supply chain.

Our DF30 platform can deliver both solution- and suspension-based formulations

Specifications are rigorously optimized for compatibility with virtually all types of pMDI formulations.

We provide comprehensive expert support to accelerate and derisk your pMDI development project

Formulation development, regulatory and technical support services speed you from early development to market. A collaborative network of global partners lends localized support experts wherever you’re based.

We combine multiple manufacturing sites with in-house elastomer manufacture to deliver a secure supply

For safe and reliable delivery, to a consistent standard of pressurized metered dose inhalers, across the globe.

We Have a Broad Range of Value Added Services to Accelerate and Derisk Your Drug Product Development.

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