Dibawah ini adalah informasi produk dari Delivered Dose Uniformity DPI. Untuk diskusi produk bisa menghubungi kontak PT. Andaru Persada Mandiri via whatsapp 087777277740 atau telepon 0251-7504679.
The basic requirements for DPI DDU testing are the same as for MDI testing, namely DUSA, mouthpiece adapter, vacuum pump and flow meter. However, a critical flow controller (e.g. Critical Flow Controller TPK 100i) to measure the pressure drop across the device and control the flow conditions during testing is also required. This is because most DPIs are passive breath-actuated devices which rely on the patient’s inspiration rather than a propellant for dose aerosolisation and delivery. The testing of DPIs is further complicated by the fact that different inhalers provide varying degrees of flow resistance, i.e. some require more effort to inhale through than others.
Specifications Delivered Dose Uniformity DPI
| DDU for DPIs: Test Specifications | |
|
Flow Rate (Q) |
Device dependent (4 kPa) |
|
Air Volume (Ph. Eur./EMA) |
4 litres |
|
Air Volume (USP/FDA) |
2 litres |
Regulations & Guidelines Delivered Dose Uniformity DPI
The sampling procedure and acceptance criteria for the DDU testing of DPIs varies according to the regulatory authority concerned.
|
Organisation |
Chapter(s)/Guidance |
Key DDU Tests |
|
EMA |
Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products 2006 |
Pharmaceutical Development:
Product Manufacture:
|
|
Ph. Eur. |
Chapter 0671 |
Uniformity of Delivered Dose Number of Deliveries per Inhaler |
|
FDA |
MDI & DPI Products Quality Considerations |
Delivered Dose Uniformity |
|
USP |
Chapter <601> |
Delivered Dose Uniformity of Product Dose Uniformity Over the Entire Unit Life |
|
Ch.P. |
Chapter 0111 |
Delivered Dose Uniformity |
|
JP |
Chapter 6.14 |
Delivered Dose Uniformity |
DDU Over the Entire Contents Delivered Dose Uniformity DPI
|
Organisation |
1st Test Tier No. of Inhalers |
1st Test Tier Criteria |
2nd Test Tier No. of Inhalers |
2nd Test Tier Criteria |
|
Ph.Eur |
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 |
|
USP |
10 Inhalers/ 1 prime 1 beginning of life 1 end of life |
N/A |
N/A |
N/A |
|
EMA |
As per Ph.Eur. |
As per Ph.Eur. |
As per Ph.Eur. |
As per Ph.Eur. |
|
FDA |
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** |
|
Ch.P. |
1Inhaler/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 |
|
JP |
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 DPIs: Manual Test System Set-Up
The basic requirements for DPI DDU testing are the same as for MDI testing, namely DUSA, mouthpiece adapter, vacuum pump and flow meter. However, a critical flow controller (eg. Critical Flow Controller TPK 1001) to measure the pressure drop across the device and control the flow conditions during testing is also required.
This is mandatory because most DPIs are passive breath actuated devices which rely on the patient’s inspiration rather than a propellant for dose aerosolisation and delivery. The testing of DPIs is further complicated by the fact that different inhalers provide
varying degrees of flow resistance, i.e. some require more effort to inhale through than others.
Related Accessories Delivered Dose Uniformity DPI
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.
Footswitch
Connecting directly to the Critical Flow Controller TPK 1001, the Footswitch enables precise synchronisation of DPI device actuation with the onset of flow.
DDU of DPIs: Test System Component Parts
- Dose Uniformity Sampling Apparatus for DPIs
- Vacuum Pump : Ideal for the higher, sonic flow rate testing requirements of DPIs, the High Capacity HCP6 and Super Capacity SCP6 Vacuum Pumps represent 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.
- Critical Flow Controller (TPK) : Simplify DPI test system set-up in accordance with pharmacopoeial recommendations with the Critical Flow Controller series. Positioned between the DUSA and vacuum pump, the Critical Flow Controller TPK 1001 ensures critical (sonic) flow conditions during testing it measures and records all parameters required for testing and controlling flow conditions.
- 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.
- 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).
- 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. Please note: only for multi-dose devices.
- 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.
DDU Over the Entire Contents
In the case of DPI reservoir type devices, tests should be carried out throughout the life of the inhalerie. dose uniformity over the entire contents.
Qualification
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.
Related Applications Delivered Dose Uniformity DPI
We also offer a range of equipment for additional DPI testing application support:
- For better in vitro-in vivo correlation (IVIVC) testing
- For USP product-specific monograph testing
Semi-Automation Tools Delivered Dose Uniformity DPI
- Improve efficiency
- Reduce variability
- Eliminate handling errors
- Increase testing capacity
Training, Servicing, & Support Delivered Dose Uniformity DPI
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 DPI. 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.
