DF30 Technology Platform

Delivering solutions, shaping the future.

Key Benefits

Suitable for both solution and suspension-based formulations

Compatible with all pMDI filling technologies

Robust designs guaranteeing accurate and consistent performance (seal, dose, aerosol, etc.)

Complete services and support to allow faster regulatory approval of your pMDI drug product

Customer trust in our robust supply chain.

Key Differentiators

Proprietary elastomer formulations designed for specific therapeutic applications

Our dedicated in-house Elastomer Center which develops, improves and manufactures ultra-clean elastomers

Three valve manufacturing facilities strategically located across Europe and Asia

Extractable and toxicology dossiers to support/expedite your regulatory filings

Aptar Pharma is the world-leading supplier of aerosol metering valves. The metering valve is a key sub-system of a pMDI which enables an accurate and repeatable dose of drug to be delivered as a fine aerosol to the patient’s airways.

Elastomer Center

Elastomeric seals for valves are critical components that must maintain their function and chemical integrity within the challenging environment of the pMDI container closure system over the life-time of the drug product. To ensure these challenges are met, Aptar Pharma continues to develop and improve its elastomeric materials to offer the following benefits:

A selection of ultra clean, highly inert elastomer gaskets, including: EPDM, thermoplastic elastomer (TPE) and our novel COCe

Specific gasket designs (dynamic and static sealing)

Extensive testing in our labs to challenge our gaskets and valves with a variety of drug formulations

Customer trust: each year over 2.5 billion gaskets are manufactured at our Elastomer Center for subsequent use in Aptar Pharma valves and pumps

DF30 Technology Platform

Apta Pharma’s Elastomer Center

Our DF30 metering valve platform has been the industry gold standard for more than 25  years and is constantly improved and optimized.Aptar Pharma continues to set new standards in the design, use of materials, manufacture and control of metering valves. We offer a variety of off-the-shelf valve configurations and value-added services to meet all of our stakeholders’ requirements.

Valve Ref.(20mm)

StemDesign

+ diameter(mm)

Metering Chamber

(µl)

Materials

Metering Chamber & Body

Stem (upper/lower)

Elastomers (Dynamic)

Elastomer (Static)

Gathering Ring

DF316

RCU3.16

25, 50, 61, 75 Acetal (POM) POM Nitrile or EPDMNitrile, EPDM

or COCePolyamide

DF30Plusor

DF316Hybrid 28, 50, 63 Polyester (PBT) POM or PBT EPDM EDPM or COCe

Polyamideor

Polyethylene

Df30 Product Range

DF30 Performance

Our Novel COCe Material (static sealing gasket)This novel Cyclic Olefin Copolymer sealing material presents a unique combination of properties which can be customized

by varying the chemical structure of the copolymer. Aptar Pharma has developed and manufactures a component that offers

ultra low extractables in conjunction with low water absorption and excellent static leakage barrier protection properties.

Fig. 1- Static leakage measured at various crimp parameters Fig. 2 - Extractable levels of various Aptar Pharma gasket materials

COCe Min crimp / P134a + 15% EtOH

COCe Max crimp / P134a + 15% EtOH

COCe Min crimp / P134a

COCe Max crimp / P134a

epdm / p134a + 15% EtOH

epdm / p134a

T0

Nitrile EPDM 1 EPDM 2 EPDM 3 COCe

0

0

4000

8000

12000

1600014200

5300

2500

1400

600

200

400

Leakag

e (

mg

)

Extr

acti

ves

level (µ

g/g

)

600

T1M T3M T6M T9M T12M

sho

t w

eig

hts

(m

g)

0

1 21

---- Valve 1 ---- Valve 2 ---- Valve 3 ---- Valve 4 ---- Valve 5

41 61 81 101 121 141 161 181 201 221 241

10

20

30

40

50

60

Cumulated leakage uncer accelarated conditions

(40°C / 75% RH)

Measured by HPLC and GCFID ; includes both fatty acids and volatile

extractives

Shot weights through life - T0

Figures 3 and 4: Shot weight and delivered dose uniformity from the beginning to the end of the lifespan - Salbutamol HFA 134a & 15%EtOH

60

80

100

120

140

160

180

200

can 1

can 2

can 3

can 4

can 5

-20%

+20%

-25%

+25%

mean

Delivered dose uniformity - T0 (USP/EP test protocols)

Salb

uta

mo

l su

lfate

(µg

)

B M E

The DF30 platform is supported by the following associated Services to expedite your drug product development:

Customized Drug Delivery Solutions

Designed and developed by multi-disciplinary project teams with a customer-centric approach

Quality-by-Design

Formulation, Filling, Packaging And Valve Sampling

Technical support in formulation development

Pilot filling equipment for R&D studies

Off-the-shelf formulation packages available

Dedicated technical expert to support clients (on-site) with crimping & filling enquiries

Dedicated sampling lab to expedite valve sampling enquiries

Analytical Laboratories

Elastomer and plastic extractables, bioburden, silicon oil assay

Full extractable and toxicology packages to support regulatory filing

Physical Laboratories

Aerodynamic sizing and spray characterization

Mechanical, stress and content uniformity testing, moisture content

Non-destructive 3D tomography imaging

Regulatory Expertise

Dedicated regulatory affairs experts

30 DMFs and over 50 pass NDAs and ANDAs generated

12/2

016

- v

ers

ion

1

aptar.com/pharma