Delivered Dose Uniformity MDI

Dibawah ini adalah informasi produk dari Delivered Dose Uniformity MDI. Untuk diskusi produk bisa menghubungi kontak PT. Andaru Persada Mandiri via whatsapp 087777277740 atau telepon 0251-7504679.

Gambar Produk Delivered Dose Uniformity MDI

Metered Dose Inhaler (MDI) aerosol characteristics are relatively insensitive to changes in air flow rate because the aerosolisation and dispersion mechanisms are dependent on the force generated by the propellant, rather than the patient’s inspiratory effort. Therefore, for MDIs, the test flow rate is fixed at an arbitrary value of 28.3 L/min. A vacuum pump is used to draw air through the assembled test set-up at this flow rate. However, these test conditions are not applied for DDU testing when the MDI is intended for use with an add-on device such as a spacer or valved holding chamber (VHC).

Specifications Delivered Dose Uniformity MDI

Regulations & Guidelines

The sampling procedure and acceptance criteria for the DDU of MDIs varies according to the regulatory authority concerned.



Key DDU Tests


Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products 2006

Pharmaceutical Development:

  • DDU Through Container Life
  • DDU Over Patient Flow Rate Range

Product Manufacture:

  • Mean Delivered Dose
  • Delivered Dose Uniformity
  • Content Uniformity/ Uniformity of Dosage Units

Ph. Eur.

Chapter 0671

Uniformity of Delivered Dose Number of Deliveries per Inhaler


MDI & DPI Products Quality Considerations Draft Guidance 2018

Delivered Dose Uniformity


Chapter <601>

Delivered Dose Uniformity of Product Dose Uniformity Over the Entire Unit Life


Chapter 0111

Delivered Dose Uniformity


Chapter 6.14

Delivered Dose Uniformity

DDU Over the Entire Contents Delivered Dose Uniformity MDI


1st Test Tier No. of Inhalers

1st Test Tier Criteria

2nd Test Tier No. of Inhalers

2nd Test Tier Criteria


10 Inhalers/ 1 prime

3 beginning of life 4 middle of life 3 end of life


9/10 doses to be 75-125% of Mean All doses to be 65-135% of Mean Mean to be 85-115% of LC

20 Inhalers/ 1 dose

27/30 doses to be 75-125% of Mean Value

All doses to be 65-135% of Mean Value

Mean Value to be 85-115% of LC


10 Inhalers/1 prime 1 beginning of life 1 end of life





As per Ph.Eur.

As per Ph.Eur.

As per Ph.Eur.

As per Ph.Eur.


10 Inhalers/ 1 beginning of life 1 end of life

18/20 doses to be 80-120% 20/20 to be 75 125% of TDD** Mean to be 85-115% of TDD**

20 Inhalers/ 1 beginning of life 1 end of life

54/60 doses to be 80-120% of TDD

60/60 to be 75-125% of TDD**

Mean to be 85-115% of TDD**


1 Inhaler/10 doses (MDIs) and Multidose DPs) 10 inhalers/1 dose of each

9/10 doses to be 75 125% and all to be 65 135% of Average Delivered Dose Mean to be 80-120% of LC

2 inhalers/20 doses 20 inhalers/1 dose of each

27/30 doses to be 75-125% and all to be 65: 135% of Average Delivered Dose Mean to be 80:120% of LC


1 Inhaler/10 doses

9/10 to be 75 125% of Mean Value All to be 65 135% of Mean Value) Mean to be 85 115% of LC

2 inhalers/20 doses

27/30 doses to be 75 125% of Mean Value

All to be 65 135% of Mean Value Mean to be 85 115% of LC

*Label Claim **Target Delivered Dose

DDU of MDIs: Manual Test System Set-Up

The minimum set-up for DDU testing as specified by the Ph. Eur. comprises a sample collection tube, fitted at one end with a suitable mouthpiece adapter to accept the inhaler under test and connected at the other end to a vacuum pump capable of continuously drawing 28.3 L/min through the inhaler.

In addition to the specifications laid down by the Ph. Eur., the FDA recommends and the USP specifies that the volume of air to be sampled should not exceed 2 litres; this being the volume of air adjudged to be typical of the average patient.

This additional criterion can be met by positioning an electronically operated timer controlled two-way solenoid valve, such as that incorporated in the Breath Actuation Controller BAC 100i.

DDU for MDIs: Test Specifications
Flow Rate (Q)

28.3 L/min

Air Volume (Ph. Eur./EMA)

Not defined

Air Volume (USP/FDA)

2 litres

Related Accessories

DUSA Collection Tube Stand

Designed for the convenient transfer of multiple DUSA for MDIs around the laboratory.

Temperature and Relative Humidity Sensor

Ideal for measuring environmental test conditions.

MDI Actuation Sensor/Footswitch

Suitable for most commercially available MDI canisters, the MDI Actuation Sensor connects directly to the Breath Actuation Controller BAC 1001 to ensure precise synchronisation of MDI actuation. Alternatively, a Footswitch can be attached to trigger actuation.

DDU of MDIs: Manual Test System Component Parts

  1. Dose Uniformity Sampling Apparatus
  2. Vacuum Pump : Designed for optimal operation at the low flow rates required for MDI testing, the Low Capacity LCP6 Vacuum Pump represents the latest in high performance, low maintenance, vacuum pump technology. Our Vacuum Pump range is specifically designed for use in the testing of OINDPs in accordance with pharmacopoeial requirements.
  3. Breath Actuation Controller (BAC) : Ensuring that the volume of air sampled does not exceed pharmacopoeial specifications, the Breath Actuation Controller BAC 100i contains an electronically operated, timer-controlled two-way solenoid valve and is positioned between the DUSA and vacuum pump.
  4. Flow Meter : Used for establishing accurate and consistent inlet flow rate during testing, our range of Flow Meters measure and control flow rates to the accuracy specified by the pharmacopoeias.
  5. Inhaler Testing Workstation (ITW) : Designed to keep the sampling apparatus organised during testing and improve workflow efficiency, the Inhaler Testing Workstation ITW holds the DUSA collection tube, vacuum connector, flow meter and waste shot collector (WSC2).
  6. Waste Shot Collector and Switching Valve : A compact vacuum filtration system, the Waste Shot Collector WSC2 captures aerosols emitted from repeated actuations of the inhaler, trapping large quantities of the drug for safe disposal. The Switching Valve is used to re-direct air flow between the collection device and WSC2 for quick and easy dose wasting.
  7. Mouthpiece Adapter : Moulded from high quality silicone rubber, our Mouthpiece Adapters guarantee an airtight seal between the inhaler and the test apparatus. Custom Mouthpiece Adapters are available upon request.


Good Manufacturing Practices (GMP) regulations require that

  • The test methods used to monitor pharmaceuticals must meet proper standards of accuracy and reliability
  • Companies should establish procedures to ensure the fitness for use of instruments that generate data supporting product testing

Copley provides a range of qualification documentation, services and tools to meet these requirements.

DDU of MDIs: Semi-Automated Test System Set-Up

The Vertus automated shake, fire and shot waste range is made up of integrated turn-key solutions for precise, controlled and reproducible MDI testing.

  1. Improve inhaler testing accuracy and reproducibility
  2. Increase productivity and reduce hassle
  3. Replicate test methods across different sites with ease
  4. Reduce handling errors and costly out-of- specification results

Compatible with most MDIs, the Vertus systems offer analysts complete control over:

  • The speed, angle and duration of shaking, ahead of actuation
  • Firing force and the speed of application and release of that force
  • The time delay between the end of shaking and device actuation

Vertus II & Vertus Plus
Offering high productivity, walkaway MDI testing, the Vertus Il and Vertus Plus can collect doses at the start, middle and end of product life (including shots to waste as required) all without manual intervention. The Vertus Plus also offers optional shot weight collection.

Accepting up to 10 inhalers per run, the DecaVertus is a high-throughput shake and fire-to-waste system, ideal for alleviating the burden of tedious through-life testing.

Related Applications Delivered Dose Uniformity MDI

We also offer a range of equipment for additional MDI testing application support:

  1. For better in vitro-in vivo correlation (IVIVC) testing
  2. For cold Freon effect testing
  3. For USP product-specific monograph testing

Semi-Automation Tools Delivered Dose Uniformity MDI

  • Improve efficiency
  • Reduce variability
  • Eliminate handling errors
  • Increase testing capacity

DUSA Shaker

Holding up to 21 MDI DUSA collection tubes, the DUSA shaker automates the internal rinsing of the tubes to ensure full, fast and repeatable drug dissolution and drug recovery from internal surfaces.

Training, Servicing & Support

We offer a comprehensive range of services from bespoke product design to installation, expert training and technical support, optimising all aspects of pharmaceutical testing from start to finish.

  • Training
  • Servicing
  • Support
  • Design

Sumber informasi produk didapat dari website principle langsung pada tautan berikut : copleyscientific

Demikian informasi produk Delivered Dose Uniformity MDI. Bagi anda yang membutuhkan diskusi cepat produk ini bisa menghubungi contact PT. Andaru Persada Mandiri via whatsapp 087777277740 atau telepon 0251-7504679. Link alamat kami sertakan pada Google Maps.

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