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Driving Results in Inhaler Testing
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Driving Results in Inhaler Testing
Product catalog summary
About Us
Copley Scientific, established in 1946, is a leading global manufacturer of inhaler test equipment, headquartered in Nottingham, UK. The company is renowned for its high-quality pharmaceutical testing equipment, designed and manufactured in the UK, and offers comprehensive product support and training.
Copley Scientific, established in 1946, is a leading global manufacturer of inhaler test equipment, headquartered in Nottingham, UK. The company is renowned for its high-quality pharmaceutical testing equipment, designed and manufactured in the UK, and offers comprehensive product support and training.
Quality Management
Copley Scientific is committed to excellence, employing Quality by Design (QbD) principles and holding ISO 9001:2015 certification. Continuous improvement is a core focus, aiming to exceed industry expectations.
Copley Scientific is committed to excellence, employing Quality by Design (QbD) principles and holding ISO 9001:2015 certification. Continuous improvement is a core focus, aiming to exceed industry expectations.
Inhaler Testing
The document outlines various inhaler types, including Metered-Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), Nebulisers, Soft Mist Inhalers (SMIs), and Nasal Products. Each type has specific characteristics and testing requirements.
The document outlines various inhaler types, including Metered-Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), Nebulisers, Soft Mist Inhalers (SMIs), and Nasal Products. Each type has specific characteristics and testing requirements.
Regulatory Compliance
The document discusses compliance with global regulatory standards and pharmacopoeias, ensuring product safety, quality, and efficacy.
The document discusses compliance with global regulatory standards and pharmacopoeias, ensuring product safety, quality, and efficacy.
Applications of OINDPs
Orally Inhaled and Nasal Drug Products (OINDPs) are used for local and systemic therapies, offering advantages over traditional oral and parenteral routes. They are used for various treatments, including diabetes, migraine, and vaccines.
Orally Inhaled and Nasal Drug Products (OINDPs) are used for local and systemic therapies, offering advantages over traditional oral and parenteral routes. They are used for various treatments, including diabetes, migraine, and vaccines.
Regulatory Bodies and Guidelines
The document outlines the roles of regulatory bodies such as the EMA, FDA, NMPA, and MHLW in regulating inhalation and nasal products. It details guidelines from these agencies, including the EMA's guidelines on pharmaceutical quality and clinical documentation, and the FDA's guidelines on metered-dose inhalers and nasal sprays.
The document outlines the roles of regulatory bodies such as the EMA, FDA, NMPA, and MHLW in regulating inhalation and nasal products. It details guidelines from these agencies, including the EMA's guidelines on pharmaceutical quality and clinical documentation, and the FDA's guidelines on metered-dose inhalers and nasal sprays.
International Harmonisation
The International Conference on Harmonisation (ICH) aims to harmonize drug regulation across regions. The document lists ICH quality guidelines, including Q8 on pharmaceutical development and Q10 on pharmaceutical quality systems, which provide a framework for managing the pharmaceutical product lifecycle.
The International Conference on Harmonisation (ICH) aims to harmonize drug regulation across regions. The document lists ICH quality guidelines, including Q8 on pharmaceutical development and Q10 on pharmaceutical quality systems, which provide a framework for managing the pharmaceutical product lifecycle.
Pharmacopoeias
The document describes the role of pharmacopoeias in setting standards for medicines, with a focus on the European Pharmacopoeia, United States Pharmacopeia, Chinese Pharmacopoeia, and Japanese Pharmacopoeia. Each has specific chapters and monographs related to inhalation and nasal drug products.
The document describes the role of pharmacopoeias in setting standards for medicines, with a focus on the European Pharmacopoeia, United States Pharmacopeia, Chinese Pharmacopoeia, and Japanese Pharmacopoeia. Each has specific chapters and monographs related to inhalation and nasal drug products.
Industry Groups
Several industry groups, such as the European Pharmaceutical Aerosol Group (EPAG) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS), work towards establishing best practices and standards for inhalation and nasal products.
Several industry groups, such as the European Pharmaceutical Aerosol Group (EPAG) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS), work towards establishing best practices and standards for inhalation and nasal products.
Conclusion
The document highlights the ongoing efforts in research, regulation, and standardization to improve the safety, quality, and efficacy of inhalation and nasal drug delivery systems.
The document highlights the ongoing efforts in research, regulation, and standardization to improve the safety, quality, and efficacy of inhalation and nasal drug delivery systems.
Specifications and Equipment Overview
The document provides detailed information on various equipment and systems used for inhaler testing, specifically focusing on Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs). It includes descriptions of mouthpiece adapters, vacuum filtration systems, and automated testing systems like the Vertus III and DecaVertus III, which enhance testing accuracy and productivity.
The document provides detailed information on various equipment and systems used for inhaler testing, specifically focusing on Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs). It includes descriptions of mouthpiece adapters, vacuum filtration systems, and automated testing systems like the Vertus III and DecaVertus III, which enhance testing accuracy and productivity.
Waste Shot Collector (WSC2)
The WSC2 is a compact vacuum filtration system designed to capture aerosols emitted during inhaler actuation, ensuring safe disposal of large drug quantities. It works in conjunction with a Switching Valve to redirect airflow for efficient dose wasting.
The WSC2 is a compact vacuum filtration system designed to capture aerosols emitted during inhaler actuation, ensuring safe disposal of large drug quantities. It works in conjunction with a Switching Valve to redirect airflow for efficient dose wasting.
Automated Testing Systems
The Vertus III and DecaVertus III systems automate the shake, fire, and shot waste processes for MDIs, offering precise control over testing parameters such as shaking speed, firing force, and timing. These systems improve testing accuracy, reduce handling errors, and increase productivity by allowing high-throughput testing.
The Vertus III and DecaVertus III systems automate the shake, fire, and shot waste processes for MDIs, offering precise control over testing parameters such as shaking speed, firing force, and timing. These systems improve testing accuracy, reduce handling errors, and increase productivity by allowing high-throughput testing.
Delivered Dose Uniformity (DDU)
DDU testing ensures the consistency of drug delivery from inhalers. The document outlines the requirements for DDU testing, including the use of breathing simulators and mouthpiece adapters. It highlights the importance of testing with add-on devices like spacers and VHCs, which affect the delivered dose.
DDU testing ensures the consistency of drug delivery from inhalers. The document outlines the requirements for DDU testing, including the use of breathing simulators and mouthpiece adapters. It highlights the importance of testing with add-on devices like spacers and VHCs, which affect the delivered dose.
Regulations and Guidelines
The document references various regulatory guidelines for inhaler testing, including those from the FDA, USP, and EMA. It emphasizes the need for accurate and reliable test methods and the establishment of procedures to ensure instrument fitness.
The document references various regulatory guidelines for inhaler testing, including those from the FDA, USP, and EMA. It emphasizes the need for accurate and reliable test methods and the establishment of procedures to ensure instrument fitness.
Additional Testing Equipment
Additional equipment for MDI and DPI testing includes the DTS 100i for drug dissolution and recovery, and the BRS 200i breathing simulator for more representative in vivo testing. The document also mentions environmental control solutions to improve test data accuracy.
Additional equipment for MDI and DPI testing includes the DTS 100i for drug dissolution and recovery, and the BRS 200i breathing simulator for more representative in vivo testing. The document also mentions environmental control solutions to improve test data accuracy.
Training, Servicing, and Support
Copley offers comprehensive services including product design, installation, training, and technical support to optimize pharmaceutical testing processes.
Copley offers comprehensive services including product design, installation, training, and technical support to optimize pharmaceutical testing processes.
Conclusion
The document provides a thorough overview of the equipment and procedures necessary for effective inhaler testing, emphasizing automation, accuracy, and compliance with regulatory standards.
The document provides a thorough overview of the equipment and procedures necessary for effective inhaler testing, emphasizing automation, accuracy, and compliance with regulatory standards.
Specifications and Procedures
Nasal sprays, aerosols, and powders typically produce droplets in the range of 20-200 microns, with a small proportion (<5%) of fine droplets under 10 microns. These fine droplets are significant as they can penetrate beyond the nasal tract into the lungs, which may be undesirable. Regulators recommend using a cascade impactor with a high volume expansion chamber to quantify the drug amount in the <10 micron range to assess lung deposition risks.
Nasal sprays, aerosols, and powders typically produce droplets in the range of 20-200 microns, with a small proportion (<5%) of fine droplets under 10 microns. These fine droplets are significant as they can penetrate beyond the nasal tract into the lungs, which may be undesirable. Regulators recommend using a cascade impactor with a high volume expansion chamber to quantify the drug amount in the <10 micron range to assess lung deposition risks.
Regulations and Guidelines
Guidelines from organizations such as Ph. Eur./EMA and USP/FDA provide standards for the pharmaceutical quality of inhalation and nasal products. These guidelines ensure that test methods meet proper standards of accuracy and reliability.
Guidelines from organizations such as Ph. Eur./EMA and USP/FDA provide standards for the pharmaceutical quality of inhalation and nasal products. These guidelines ensure that test methods meet proper standards of accuracy and reliability.
Automated and Manual Test Systems
The Vertus® III system automates the aerodynamic particle size distribution (APSD) measurement for nasal sprays and aerosols, offering control over shaking speed, angle, and duration, as well as firing force and timing. Manual test systems include components like vacuum pumps, flow rate sensors, and glass expansion chambers, suitable for quantifying drug products in the form of particles or droplets less than 10 microns.
The Vertus® III system automates the aerodynamic particle size distribution (APSD) measurement for nasal sprays and aerosols, offering control over shaking speed, angle, and duration, as well as firing force and timing. Manual test systems include components like vacuum pumps, flow rate sensors, and glass expansion chambers, suitable for quantifying drug products in the form of particles or droplets less than 10 microns.
Data Analysis and Automation Tools
Inhalytix® software automates the transformation of raw inhaler testing data into performance metrics, supporting both standard and customized impactors and impingers. Automation tools improve efficiency, reduce variability, and increase testing capacity.
Inhalytix® software automates the transformation of raw inhaler testing data into performance metrics, supporting both standard and customized impactors and impingers. Automation tools improve efficiency, reduce variability, and increase testing capacity.
Training, Servicing, and Support
A comprehensive range of services is offered, including bespoke product design, installation, expert training, and technical support, optimizing all aspects of pharmaceutical testing.
A comprehensive range of services is offered, including bespoke product design, installation, expert training, and technical support, optimizing all aspects of pharmaceutical testing.
Environmental Control Solutions
These solutions are designed to improve the accuracy, sensitivity, and reproducibility of test data, considering the effects of environmental variability.
These solutions are designed to improve the accuracy, sensitivity, and reproducibility of test data, considering the effects of environmental variability.
Inhaler Testing Workstation (ITW)
The ITW is designed to keep the cascade impactor and flow meter in position during testing, improving workflow efficiency. It is essential for inhaler testing and recommended for qualification under GMP regulations. Copley provides qualification documentation and services to meet these requirements.
The ITW is designed to keep the cascade impactor and flow meter in position during testing, improving workflow efficiency. It is essential for inhaler testing and recommended for qualification under GMP regulations. Copley provides qualification documentation and services to meet these requirements.
APSD Data Analysis Software: Inhalytix®
Inhalytix automates the transformation of raw inhaler testing data into performance metrics. It is a validated solution for APSD data management, offering automated data processing, meaningful metrics, and compliance.
Inhalytix automates the transformation of raw inhaler testing data into performance metrics. It is a validated solution for APSD data management, offering automated data processing, meaningful metrics, and compliance.
Automation Tools
Tools like the Gentle Rocker™ GR 200i, Impactor Coater™ IC 200i, and Sample Preparation Unit SPU 200i standardize processes such as drug dissolution, surface coating, and cleaning, improving efficiency and reducing variability.
Tools like the Gentle Rocker™ GR 200i, Impactor Coater™ IC 200i, and Sample Preparation Unit SPU 200i standardize processes such as drug dissolution, surface coating, and cleaning, improving efficiency and reducing variability.
Breathing Simulators
These simulators generate inhalation/exhalation profiles for more clinically representative testing. They are used to assess Delivered Dose Uniformity (DDU) and improve in vitro-in vivo correlations (IVIVCs).
These simulators generate inhalation/exhalation profiles for more clinically representative testing. They are used to assess Delivered Dose Uniformity (DDU) and improve in vitro-in vivo correlations (IVIVCs).
Flow Rate Measurement and Control
Devices are available to measure flow rate accurately, ensuring consistent inlet flow during testing. The Breath Actuation Controller BAC and Critical Flow Controller TPK are designed for specific testing needs.
Devices are available to measure flow rate accurately, ensuring consistent inlet flow during testing. The Breath Actuation Controller BAC and Critical Flow Controller TPK are designed for specific testing needs.
Environmental Control
Tools like the NGI Cooler and Glass Expansion Chambers help maintain data integrity by controlling environmental conditions during testing.
Tools like the NGI Cooler and Glass Expansion Chambers help maintain data integrity by controlling environmental conditions during testing.
Ancillaries
Additional equipment such as vacuum pumps, mouthpiece and nosepiece adapters, and the Inhaler Testing Workstation™ ITW support various testing applications.
Additional equipment such as vacuum pumps, mouthpiece and nosepiece adapters, and the Inhaler Testing Workstation™ ITW support various testing applications.
Breathing Simulator Models
The BRS 100i and BRS 200i models offer features like touchscreen interfaces, extensive data output options, and compliance with relevant standards. They support various testing applications and user management features to ensure data compliance.
The BRS 100i and BRS 200i models offer features like touchscreen interfaces, extensive data output options, and compliance with relevant standards. They support various testing applications and user management features to ensure data compliance.
Overview: The document provides detailed information on the BRS 200i and BRS 300i breathing simulators, their accessories, and related testing equipment for inhaler performance evaluation. It outlines specifications, compliance standards, and operational features, emphasizing the importance of precise environmental control and data management.
Specifications: The BRS 200i and BRS 300i simulators are designed for inhaler testing, compliant with Ph. Eur. 2.9.44, 21 CFR Part 11, and ISO 27427:2013 standards. They feature a powerful drive system, touchscreen interface, and extensive data output options, including USB and Ethernet connectivity.
Key Features: The simulators offer intuitive touchscreen controls, method storage and recall, and compatibility with various sensors for coordinated testing. They support inhalation-only profiles and are equipped with quick-release connectors for ease of use.
Accessories: A range of accessories is available, including temperature and humidity sensors, MDI actuation sensors, footswitches, and qualification kits. Extended warranties and re-calibration services are also offered.
Data Management: The BRS 300i includes user management features to ensure compliance with data integrity standards. It provides method, run, and audit reports, with all data changes time-stamped and user-attributable.
Flow Control and Testing: The document details the importance of flow rate and volume control in inhaler testing, particularly for DPIs. It describes the use of flow controllers to meet regulatory requirements and ensure accurate testing conditions.
Regulatory Compliance: The equipment and procedures comply with Ph. Eur. and USP standards, ensuring that test conditions for DPIs and other inhalers are accurately controlled and documented.
Conclusion: The document serves as a comprehensive guide for using the BRS series simulators and related equipment in inhaler testing, highlighting the critical role of precise control and data management in achieving reliable results.
Overview: The document provides detailed information on the TPK 100i and TPK 100i-R flow control systems, their features, specifications, and associated accessories for inhaler testing. It also covers the importance of air flow control in testing inhaled products and the impact of environmental conditions on test results.
Key Features: The TPK 100i and TPK 100i-R are critical flow controllers used in inhaler testing. They offer automated and manual flow settings, intuitive touchscreen interfaces, and compatibility with various inhaler testing equipment. The TPK 100i-R has reversed pneumatic connections for improved connectivity.
Technical Specifications: The TPK 100i features a resistive touchscreen, solenoid valve with 25 ms opening/closing time, and a timer range of 0-600 seconds. It supports temperature and humidity measurements and includes a footswitch or MDI actuation sensor for synchronization.
Accessories: Accessories include a temperature and humidity sensor, footswitch, MDI actuation sensor, and a label printer for report output. Calibration certificates and extended warranties are available.
Flow Rate Measurement: Accurate flow rate measurement is crucial for inhaler testing. The document describes the Flow Rate Sensor FRS and Flow Meter DFM 2000, both capable of measuring volumetric flow and providing data connectivity options.
Vacuum Pumps: Various vacuum pumps are available for different inhaler testing applications, including low, high, and super capacity pumps. Each pump type has specific features, such as low maintenance, advanced cooling, and oil-free operation.
Environmental Control: The document emphasizes the importance of controlling environmental conditions, such as temperature, humidity, and electrostatic charge, to ensure accurate and reliable inhaler testing results.
Overview: The document provides a detailed description of the EnviroMate, a benchtop environmental chamber designed for inhaler testing. It emphasizes the importance of controlling environmental conditions to ensure accurate and reproducible data for orally inhaled and nasal drug products (OINDPs).
Key Features:
- EnviroMate maintains uniform temperature and humidity, minimizing electrostatic charge to improve data accuracy and repeatability.
- It is a compact, energy-efficient solution that requires no routine maintenance and is compliant with Ph. Eur. and USP standards.
- The chamber is equipped with a sensitive temperature and humidity sensor, anti-static system, and large entry ports for easy handling of test equipment.
Technical Specifications:
- Temperature Control Range: 17 - 35ºC with an accuracy of ±2ºC.
- Humidity Control Range: 15 - 85% RH with an accuracy of ±5% RH.
- Sound Level: 63 dBA at 1m.
- Power Supply: 230V, 50Hz or 115V, 60Hz.
Ancillaries and Accessories:
- EnviroMate can interface with various inhaler testing apparatus, including NGI, ACI, and MSLI.
- Additional tools like the Anti-Static Grounding Kit, Digital Static Meter, and Electrostatic Eliminator are available to mitigate electrostatic effects.
- The NGI Cooler is designed to maintain a controlled temperature environment for nebuliser testing.
Inhaler Testing Workstation (ITW):
- The ITW is a modular workstation that aids in handling and manipulation of test apparatus, improving workflow and flexibility for different testing requirements.
- It supports DDU testing and APSD measurement applications with quick-slide attachments and stable platforms for test components.
Glass Expansion Chambers:
- Used to measure drug deposition in nasal sprays and aerosols, available in 1L, 2L, and 5L sizes.
- Designed to capture particles in the range of 0 to 10 microns, ensuring representative testing for nasal drug products.
Mouthpiece and Nosepiece Adapters:
- Custom-made adapters are available to ensure a proper seal between the device under test and the sampling apparatus.
- Bespoke design services are offered for specific device types.
Inhaler Devices and Accessories
This section lists various inhaler devices such as Rotahaler, Turbuhaler, Diskhaler, and others, along with accessories like mouthpiece adapters and inhaler support accessories. These accessories are designed to ensure proper positioning and organization during testing. Custom mouthpiece adapters are available for different testing setups, and nosepiece adapters are offered for nasal devices to ensure airtight seals during testing.
This section lists various inhaler devices such as Rotahaler, Turbuhaler, Diskhaler, and others, along with accessories like mouthpiece adapters and inhaler support accessories. These accessories are designed to ensure proper positioning and organization during testing. Custom mouthpiece adapters are available for different testing setups, and nosepiece adapters are offered for nasal devices to ensure airtight seals during testing.
Inhalytix Software
Inhalytix is a data analysis software for aerodynamic particle size distribution (APSD) of drug outputs from orally inhaled and nasal drug products (OINDPs). It supports various cascade impactors and provides a flexible, validated solution for data entry, analysis, and reporting. The software is compliant with USP and Ph.Eur. standards and offers features like equipment inventory management, custom report templates, and test method configurations.
Inhalytix is a data analysis software for aerodynamic particle size distribution (APSD) of drug outputs from orally inhaled and nasal drug products (OINDPs). It supports various cascade impactors and provides a flexible, validated solution for data entry, analysis, and reporting. The software is compliant with USP and Ph.Eur. standards and offers features like equipment inventory management, custom report templates, and test method configurations.
System Characteristics and Operation
The software includes a dashboard for system usage overview, and it operates through a three-step process: Configure, Test, and Report. Users can customize equipment configurations and test methods, allowing for detailed product information integration and precise test execution. The software supports data import and export, enhancing test result accuracy and traceability.
The software includes a dashboard for system usage overview, and it operates through a three-step process: Configure, Test, and Report. Users can customize equipment configurations and test methods, allowing for detailed product information integration and precise test execution. The software supports data import and export, enhancing test result accuracy and traceability.
Improving In Vitro-In Vivo Correlations (IVIVCs)
This section discusses the importance of enhancing clinical realism in in vitro test setups to improve IVIVCs for OINDPs. It highlights the challenges in predicting pharmacokinetic and pharmacodynamic properties due to lung complexity and patient variability. The document emphasizes the need for better IVIVCs to support bioequivalence demonstrations and Quality by Design (QbD) approaches, which are crucial for regulatory submissions and product development.
This section discusses the importance of enhancing clinical realism in in vitro test setups to improve IVIVCs for OINDPs. It highlights the challenges in predicting pharmacokinetic and pharmacodynamic properties due to lung complexity and patient variability. The document emphasizes the need for better IVIVCs to support bioequivalence demonstrations and Quality by Design (QbD) approaches, which are crucial for regulatory submissions and product development.
Regulatory Guidance and Testing Methods
The FDA's draft guidance for Beclomethasone Dipropionate aerosol suggests novel in vitro testing approaches to enhance clinical realism and improve IVIVCs. These include using representative mouth-throat models, breathing profiles, and characterizing aerosol velocity and evaporation rates. The document underscores the industry's focus on improving in vitro test methods to better reflect in vivo behavior, driven by the demand for generic OINDPs.
The FDA's draft guidance for Beclomethasone Dipropionate aerosol suggests novel in vitro testing approaches to enhance clinical realism and improve IVIVCs. These include using representative mouth-throat models, breathing profiles, and characterizing aerosol velocity and evaporation rates. The document underscores the industry's focus on improving in vitro test methods to better reflect in vivo behavior, driven by the demand for generic OINDPs.
Overview: The document discusses the importance of Critical Quality Attributes (CQAs) in understanding the differences between Test (T) and Reference (R) formulations, particularly in the context of bioequivalence for generic drugs. It emphasizes the role of CQAs in accelerating product commercialization and reducing clinical trial failures.
Demonstrating Bioequivalence (BE): The document outlines the regulatory guidance for demonstrating bioequivalence, focusing on patient, device, and formulation CQAs. Key attributes include throat geometry, breath profile, delivered dose, and aerodynamic particle size distribution.
Improving In Vitro-In Vivo Correlations (IVIVCs): Methods to improve IVIVCs include using realistic breathing profiles and throat/nasal models. These approaches aim to better represent human inhalation/exhalation profiles and improve drug delivery assessments.
Dissolution Testing: In vitro dissolution testing is highlighted as a tool for optimizing drug efficacy, ensuring consistency, and predicting bioavailability. Profiling morphological properties like particle size and shape is crucial for assessing aerosolization performance.
Cold Freon® Effect: The document describes the "cold Freon®" effect, which impacts drug delivery efficiency due to the chilling sensation caused by propellant evaporation.
Facemask Testing: The importance of facemask testing is discussed, particularly for patients unable to use a mouthpiece. The interface between the facemask and patient is critical for drug delivery.
Inhaler Testing: The document details the use of breathing simulators and realistic models to improve the clinical relevance of dose uniformity and aerodynamic particle size distribution (APSD) testing.
Ancillaries and Equipment: Various tools and equipment, such as mixing inlets and breathing simulators, are described for their role in achieving more representative testing conditions.
Alberta Idealised Throat and Nasal Inlet Models: These models are designed to mimic human anatomy for more accurate drug delivery assessments. They are validated through research and offer robust performance across different patient profiles.
Conclusion: The document provides a comprehensive overview of methods and tools to enhance the accuracy and reliability of inhaled drug delivery testing, emphasizing the importance of realistic testing conditions and advanced modeling techniques.
Overview: This document provides detailed information on various testing systems and apparatus used for assessing the performance of inhalers and nebulisers, particularly focusing on the impact of facemasks and the cold Freon® effect. It includes specifications, procedures, and recommendations for setting up and using these systems effectively.
1. Breathing Simulators and Facemask Testing:
- The document outlines the components required for a fully operational DDU test system to assess the impact of facemasks on MDIs with a Spacer/VHC. Key components include the Facemask Testing Apparatus (FMA), Filter Holder & Adapter, Face Model, and Breathing Simulators (BRS 100i and BRS 200i).
- Models are available for all age groups, with replaceable face skins to mimic real-life tissue flexibility and elasticity.
- The FMA is designed to meet critical requirements for assessing facemask impact on MDIs, with additional accessories like the FMA to NGI Interface Accessory for direct connection to the NGI Induction Port.
2. Ancillary Equipment and Flow Control:
- Flow Controllers are highlighted for their role in improving testing reproducibility by setting flow rates and sampling time delays, reducing data variability.
- The document emphasizes the importance of using a Vacuum Pump and Flow Rate Sensor (FRS) for accurate and consistent inlet flow rate measurement during testing.
3. Cold Freon® Effect and Spray Testing:
- The cold Freon® effect, caused by the chilling sensation from MDIs, can affect drug delivery efficiency. The document discusses the importance of assessing this effect using Spray Force Tester (SFT 1000) and Plume Temperature Tester (PTT 1000).
- These testers provide high precision measurements of spray force and plume temperature, which are critical for evaluating the potential for adverse patient reactions.
4. Qualification and Standards:
- The document stresses the need for pharmaceutical testing methods to meet standards of accuracy and reliability, with companies required to ensure the fitness of instruments generating data for product testing.
- Copley offers qualification documentation, services, and tools to meet GMP regulations.
5. Special Applications:
- The document briefly mentions the drive for greater efficiency in testing, suggesting ongoing debates about testing methodologies.
Introduction
The document discusses the use of Abbreviated Impactor Measurement (AIM) as part of a Quality by Design (QbD) process for assessing the aerodynamic particle size distribution (APSD) of orally inhaled products (OIPs). AIM is highlighted as a rapid screening tool in research and development (R&D) and quality control (QC) applications.
The document discusses the use of Abbreviated Impactor Measurement (AIM) as part of a Quality by Design (QbD) process for assessing the aerodynamic particle size distribution (APSD) of orally inhaled products (OIPs). AIM is highlighted as a rapid screening tool in research and development (R&D) and quality control (QC) applications.
Specifications and Procedures
The document outlines the use of cascade impactors for measuring APSD, which is crucial for both regulatory and pharmacopoeial standards. It mentions the challenges of full-resolution multi-stage cascade impaction methods, which are time-consuming and require skilled analysts. AIM is proposed as a solution to these challenges by using fewer impactor stages, thus speeding up the process and reducing errors.
The document outlines the use of cascade impactors for measuring APSD, which is crucial for both regulatory and pharmacopoeial standards. It mentions the challenges of full-resolution multi-stage cascade impaction methods, which are time-consuming and require skilled analysts. AIM is proposed as a solution to these challenges by using fewer impactor stages, thus speeding up the process and reducing errors.
Quality Control and Efficient Data Analysis (EDA)
For batch release testing and QC, simpler metrics can be used once a full APSD profile is established. EDA is introduced as a method that combines with AIM to enhance throughput and reduce analytical errors. Full-resolution testing is reserved for out-of-specification investigations.
For batch release testing and QC, simpler metrics can be used once a full APSD profile is established. EDA is introduced as a method that combines with AIM to enhance throughput and reduce analytical errors. Full-resolution testing is reserved for out-of-specification investigations.
Device Robustness and Inhaler Misuse
The document addresses issues related to inhaler misuse and its impact on critical quality attributes (CQAs). Solutions are offered to optimize inhaler designs for better drug delivery.
The document addresses issues related to inhaler misuse and its impact on critical quality attributes (CQAs). Solutions are offered to optimize inhaler designs for better drug delivery.
Specialized Test Equipment
A range of specialized test equipment is available for assessing the performance of orally inhaled and nasal drug products (OINDPs). This includes various models of abbreviated impactors like the Fast Screening Andersen (FSA) and reduced NGI (rNGI), which are designed for both QC and R&D applications.
A range of specialized test equipment is available for assessing the performance of orally inhaled and nasal drug products (OINDPs). This includes various models of abbreviated impactors like the Fast Screening Andersen (FSA) and reduced NGI (rNGI), which are designed for both QC and R&D applications.
Abbreviated Impactor Measurement (AIM)
AIM is suggested as a useful tool in R&D for fast screening of new formulations. It aims to generate clinically representative data to reduce reliance on clinical trials. The document explains the complexity of correlating in vitro measurements with deposition in the Human Respiratory Tract (HRT).
AIM is suggested as a useful tool in R&D for fast screening of new formulations. It aims to generate clinically representative data to reduce reliance on clinical trials. The document explains the complexity of correlating in vitro measurements with deposition in the Human Respiratory Tract (HRT).
Fast Screening Impactor (FSI)
The FSI is introduced as a purpose-made approach to AIM, suitable for AIM-HRT applications for MDIs, DPIs, and nasal sprays. It uses a two-stage separation process for accurate and efficient particle size distribution analysis.
The FSI is introduced as a purpose-made approach to AIM, suitable for AIM-HRT applications for MDIs, DPIs, and nasal sprays. It uses a two-stage separation process for accurate and efficient particle size distribution analysis.
Volume and Resistance Compensator (VRC)
The VRC is designed to match flow resistance and flow rate rise-time profiles between full-resolution and abbreviated impactors, ensuring comparable conditions for aerosol generation and improving data comparability.
The VRC is designed to match flow resistance and flow rate rise-time profiles between full-resolution and abbreviated impactors, ensuring comparable conditions for aerosol generation and improving data comparability.
Conclusion
The document emphasizes the importance of AIM and related technologies in improving the efficiency and accuracy of APSD measurements, supporting the development and quality control of inhaled drug products.
The document emphasizes the importance of AIM and related technologies in improving the efficiency and accuracy of APSD measurements, supporting the development and quality control of inhaled drug products.
Volume and Resistance Compensator (VRC) Performance:
The document discusses the performance of the Volume and Resistance Compensator (VRC), highlighting its role in maintaining pressure over time. A graph illustrates the relationship between pressure (kPa) and time (seconds), showing how the VRC stabilizes pressure.
The document discusses the performance of the Volume and Resistance Compensator (VRC), highlighting its role in maintaining pressure over time. A graph illustrates the relationship between pressure (kPa) and time (seconds), showing how the VRC stabilizes pressure.
Generic Drug Development and Inhaler Testing:
The FDA and USP have issued guidelines and monographs for the development of generic drugs, particularly for asthma and COPD treatments. These guidelines include specifications for Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) testing, which are critical for ensuring bioequivalence with reference drugs.
The FDA and USP have issued guidelines and monographs for the development of generic drugs, particularly for asthma and COPD treatments. These guidelines include specifications for Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) testing, which are critical for ensuring bioequivalence with reference drugs.
Aerodynamic Particle Size Distribution (APSD):
APSD measurements are conducted using an Andersen Cascade Impactor (ACI) with specific modifications for aerosols and powders. The document specifies apparatus requirements for testing Fluticasone Propionate/Salmeterol aerosols and powders, including induction ports and sample collection apparatus.
APSD measurements are conducted using an Andersen Cascade Impactor (ACI) with specific modifications for aerosols and powders. The document specifies apparatus requirements for testing Fluticasone Propionate/Salmeterol aerosols and powders, including induction ports and sample collection apparatus.
Albuterol Inhalation Aerosols:
A draft monograph specifies the use of a special glass sample collection apparatus for DDU testing of Albuterol aerosols. APSD measurements require a modified induction port and inlet sleeve.
A draft monograph specifies the use of a special glass sample collection apparatus for DDU testing of Albuterol aerosols. APSD measurements require a modified induction port and inlet sleeve.
Patient Exhalation Simulator (PES):
The PES simulates patient exhalation into inhaler devices, allowing developers to assess the impact of misuse on drug delivery. It features adjustable air flow temperature and flow rate, with specifications for temperature, humidity, and flow rate.
The PES simulates patient exhalation into inhaler devices, allowing developers to assess the impact of misuse on drug delivery. It features adjustable air flow temperature and flow rate, with specifications for temperature, humidity, and flow rate.
Automation in Inhaler Testing:
Automation solutions, such as the Vertus III series, enhance testing efficiency and reproducibility by automating shake, fire, and flow control for MDIs, nasal sprays, and aerosols. These systems reduce variability and improve data integrity.
Automation solutions, such as the Vertus III series, enhance testing efficiency and reproducibility by automating shake, fire, and flow control for MDIs, nasal sprays, and aerosols. These systems reduce variability and improve data integrity.
Key Features of Vertus III Range:
The Vertus III range offers precise control over test parameters, compatibility with various collection devices, and compliance with international standards. It includes features like an integrated static eliminator and an intuitive touchscreen interface.
The Vertus III range offers precise control over test parameters, compatibility with various collection devices, and compliance with international standards. It includes features like an integrated static eliminator and an intuitive touchscreen interface.
Overview: The document provides a detailed technical description of the Vertus III+ and DecaVertus III systems, focusing on their capabilities in inhaler testing, particularly for measuring shot weight and automating testing processes. It highlights the systems' compliance with various pharmacopoeial standards and their compatibility with multiple testing interfaces.
Key Features:
- Shot Weight Measurement: The Vertus III+ includes an integrated analytical balance for measuring shot weight, aiding in the consistency assessment of drug release and troubleshooting.
- Automation: Both systems offer automation features that streamline testing processes, reducing manual input and enhancing efficiency.
- Exhaust Port: Designed for the safe extraction of flammable propellants and high potency drugs, ensuring safety during testing.
Technical Specifications:
- Shaking and Firing Control: Parameters such as shake speed, angle, and duration, as well as firing force and angle, are precisely controlled.
- Air Flow Control: Independent air flow control for each channel minimizes clogging and supports high-volume testing.
- User Interface: A 10.1” color touchscreen provides an intuitive user experience.
- Connectivity: Includes Ethernet, USB, RS-232, and options for remote support and field servicing.
Compliance and Reporting: The systems comply with Ph. Eur., EMA, USP, FDA, ChP, and NMPA standards, and offer extensive data output options, including run, audit, and method reports.
Accessories and Support: A wide range of accessories and spare parts are available, along with extended warranty options and remote support services.
Additional Systems:
- DUSA Shaker DTS 100i: Automates drug recovery from DUSA collection tubes, enhancing productivity and reducing variability.
- Impactor Coater IC 200i: Applies coatings to impactor stages to prevent particle bounce during APSD sampling.
Overview: The document provides detailed information on various devices and systems used in the application of surface coatings and drug recovery processes in laboratory settings, specifically for aerodynamic particle size distribution (APSD) sampling. It highlights the features, specifications, and accessories of the Impactor Coater IC 200i, Gentle Rocker GR 200i, Impactor Genie IG 200i, Sample Preparation Unit SPU 200i, and the Impactor Cleaning System.
1. Impactor Coater IC 200i:
- Standardizes surface coating application, reducing variability and increasing productivity.
- Features include a touchscreen interface, compatibility with various coating solutions, and extensive data output options.
- Specifications: Flow rate (0-100%), dispense time (0-10 minutes), dimensions (590 x 320 x 250 mm).
- Accessories include collection trays, tubing sets, and documentation for qualification and maintenance.
2. Gentle Rocker GR 200i:
- Facilitates drug recovery by gently agitating solvents for complete dissolution.
- Features include adjustable agitation speed (10-60 RPM), touchscreen interface, and dust cover protection.
- Specifications: Run time up to 100 hours, dimensions (590 x 320 x 235 mm).
- Accessories include low evaporation covers and qualification tools.
3. Impactor Genie IG 200i:
- Combines the functionalities of the IC 200i and GR 200i for efficient APSD impactor preparation and drug recovery.
- Features include high-precision multichannel dispenser and innovative tray tilting function.
- Accessories include low evaporation covers and storage cabinets.
4. Sample Preparation Unit SPU 200i:
- Automates drug recovery procedures, reducing testing bottlenecks and RSI risks.
- Features include variable speed control, intuitive touchscreen interface, and small footprint.
- Specifications: Speed (20-60 RPM), dimensions vary based on fixture.
- Accessories include fixtures for various induction ports and qualification documentation.
5. Impactor Cleaning System:
- Ensures thorough cleaning and drying of cascade impactors using ultrasonic cleaning, rinsing, aspiration, and drying.
- Features include consistent cleaning, benchtop system, and suitable for NGI and ACI cleaning.
- Accessories include carrying/wash racks and stainless steel drip trays.
Conclusion: The document provides comprehensive information on the equipment and processes for efficient laboratory operations related to APSD sampling, emphasizing automation, precision, and ease of use.
Introduction
The document discusses the importance of Analytical Method Validation (AMV) and Good Manufacturing Practices (GMP) in ensuring the suitability of analytical and software procedures. It highlights the ambiguity in the terms "validation" and "qualification" and the USP's efforts to clarify these terms.
The document discusses the importance of Analytical Method Validation (AMV) and Good Manufacturing Practices (GMP) in ensuring the suitability of analytical and software procedures. It highlights the ambiguity in the terms "validation" and "qualification" and the USP's efforts to clarify these terms.
Specifications and Standards
The USP has introduced chapters to address GMP requirements, including <1058> for Analytical Instrument Qualification, <1225> for Validation of Compendial Procedures, and <1603> for Good Cascade Impactor Practices. These chapters provide guidelines for ensuring the accuracy and reliability of test methods and the fitness of instruments.
The USP has introduced chapters to address GMP requirements, including <1058> for Analytical Instrument Qualification, <1225> for Validation of Compendial Procedures, and <1603> for Good Cascade Impactor Practices. These chapters provide guidelines for ensuring the accuracy and reliability of test methods and the fitness of instruments.
Analytical Instrument Qualification (AIQ)
AIQ involves a four-phase approach: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The purpose of AIQ is to ensure quality analysis before testing, while system suitability tests ensure quality during sample analysis.
AIQ involves a four-phase approach: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The purpose of AIQ is to ensure quality analysis before testing, while system suitability tests ensure quality during sample analysis.
Inhaler Testing and Errors
The performance of inhaler testing equipment can be affected by analytical errors and instrument-related errors. Copley offers products and services to reduce errors in Orally Inhaled and Nasal Drug Product (OINDP) testing, including automation and validated analytical procedures.
The performance of inhaler testing equipment can be affected by analytical errors and instrument-related errors. Copley offers products and services to reduce errors in Orally Inhaled and Nasal Drug Product (OINDP) testing, including automation and validated analytical procedures.
Impactor Mensuration and Maintenance
Mensuration ensures that cascade impactors conform to critical dimensions as per USP and Ph.Eur. standards. Regular mensuration is recommended to monitor compliance and predict when maintenance is needed. Copley provides mensuration services and tools for impactor maintenance.
Mensuration ensures that cascade impactors conform to critical dimensions as per USP and Ph.Eur. standards. Regular mensuration is recommended to monitor compliance and predict when maintenance is needed. Copley provides mensuration services and tools for impactor maintenance.
Qualification and Calibration Services
Copley offers comprehensive servicing, maintenance, and qualification options, including in-house and on-site services. Documentation is provided to ensure compliance with regulatory standards.
Copley offers comprehensive servicing, maintenance, and qualification options, including in-house and on-site services. Documentation is provided to ensure compliance with regulatory standards.
Training and Support
Copley provides training programs for OINDP testing, covering regulatory requirements and testing fundamentals. The Inhaler Testing Academy offers a combination of lectures and practical demonstrations for both beginners and experienced analysts.
Copley provides training programs for OINDP testing, covering regulatory requirements and testing fundamentals. The Inhaler Testing Academy offers a combination of lectures and practical demonstrations for both beginners and experienced analysts.
Product Protection and Design Support
Copley offers extended product protection plans and design support for solving specific problems in inhaler testing. A global network of distributors ensures comprehensive customer support.
Copley offers extended product protection plans and design support for solving specific problems in inhaler testing. A global network of distributors ensures comprehensive customer support.
Training Overview
Copley Scientific offers a range of training programs, including routine induction training for new staff, bespoke training programs, and on-site training. The training is customizable to specific requirements and includes peer-to-peer learning and industry networking opportunities. Certification is provided upon completion.
Copley Scientific offers a range of training programs, including routine induction training for new staff, bespoke training programs, and on-site training. The training is customizable to specific requirements and includes peer-to-peer learning and industry networking opportunities. Certification is provided upon completion.
Inhaler Testing Academy
The Inhaler Testing Academy provides specialized training in inhaler testing, focusing on various methodologies and equipment used in the industry. Key topics include Abbreviated Impactor Measurement (AIM), Andersen Cascade Impactor (ACI), and Next Generation Impactor (NGI).
The Inhaler Testing Academy provides specialized training in inhaler testing, focusing on various methodologies and equipment used in the industry. Key topics include Abbreviated Impactor Measurement (AIM), Andersen Cascade Impactor (ACI), and Next Generation Impactor (NGI).
Equipment and Procedures
The document lists a comprehensive range of equipment and procedures related to inhaler testing, such as:
The document lists a comprehensive range of equipment and procedures related to inhaler testing, such as:
- ACI and NGI cleaning systems
- Automated drug recovery and flow control systems
- Breathing simulators and patient breath profile analysis
- Drug delivery devices and dosage unit sampling apparatus
- Environmental control chambers and electrostatic eliminators
Standards and Regulations
The document references various standards and regulatory bodies, including the European Medicines Agency (EMA), United States Pharmacopeia (USP), and International Standards Organisation (ISO). It emphasizes compliance with ISO 9001:2015 Quality Management System and other relevant guidelines.
The document references various standards and regulatory bodies, including the European Medicines Agency (EMA), United States Pharmacopeia (USP), and International Standards Organisation (ISO). It emphasizes compliance with ISO 9001:2015 Quality Management System and other relevant guidelines.
Contact Information
For more information on training packages, contact Copley Scientific at [email protected] or call +44 (0)115 961 6229.
For more information on training packages, contact Copley Scientific at [email protected] or call +44 (0)115 961 6229.
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Catalog excerpts
Driving Results in Inhaler Testing METERED-DOSE INHALERS • DRY POWDER INHALERS NEBULISERS • SOFT MIST INHALERS • NASAL PRODUCTS
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Inhaler Testing About Us Driving Results for Over 75 Years Copley Scientific, founded in 1946 and headquartered in Nottingham, UK, remains a family-owned and managed company. With a rich history spanning nearly eight decades, we have solidified our position as the leading global manufacturer of inhaler test equipment. Additionally, we are well-recognised as a reliable provider of high quality test instrumentation for other pharmaceutical dosage forms, including tablets, capsules, creams, ointments and powders. We continue to work closely with industry groups and leading experts to bring relevant...
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The Copley Promise Innovative Novel solutions that maximise understanding and productivity Compliant Certified to the standards defined by global regulators and pharmacopoeias Trusted Quality products with accuracy, robustness and reliability built-in
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Inhaler Testing ISO 9001: 2015 Quality Management System 2 Orally Inhaled & Nasal Drug Products (OINDPs) Orally Inhaled Drug Products 7 Metered-Dose Inhalers (MDIs) 7 Dry Powder Inhalers (DPIs) 8 Soft Mist Inhalers (SMIs) 10 Nasal Drug Products 10 Organisations and their Roles 12 Regulatory Bodies in the UK, European Union, China, Japan and USA 12 International Regulation and Harmonisation 14 Drug Safety, Quality and Efficacy -The Pharmacopoeias 15 United States Pharmacopeia (USP) 15 Device Safety, Quality and Efficacy - International Standards Organisation (ISO) 16 European Pharmaceutical Aerosol...
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Morphology Cold Freon® Effect Spray Force Tester SFT 1000 256 Plume Temperature Tester PTT 1000 258 Special Applications Abbreviated Impactor Measurement (AIM) 261 Fast Screen Andersen (FSA) 263 Fast Screening Impactor (FSI) 266 Volume and Resistance Compensator VRC 268 Generic Drug Development 270 Fluticasone Propionate/Salmeterol Aerosols & Powders 271 Albuterol Inhalation Aerosols 274 Device Robustness/Inhaler Misuse 276 Patient Exhalation Simulator PES 276 Stage and Components Mensuration 312 Data Interpretation 313 Impactor Performance Restoration 314 In-House and On-Site Equipment Servicing...
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Inhaler Testing Orally Inhaled & Nasal Drug Products (OINDPs) The range of OINDPs available is broad, encompassing inhalers (metered-dose, dry powder and soft mist), nebulisers (jet, ultrasonic and vibrating mesh) and nasal sprays, aerosols and powders (aqueous-based, propellant-based and dry powder). Metered-Dose Soft Mist Nasal Spray Nasal Powder
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Orally Inhaled & Nasal Drug Products Orally Inhaled Drug Products Metered-Dose Inhalers (MDIs) MDIs use a propellant to deliver a fixed volume of liquid solution or suspension to the patient in the form of an aerosol. They are small, inexpensive, convenient for the user and suitable for a wide range of drugs. However, the use of MDIs requires good coordination and technique to actuate the device. The actuation force needed means they are not always suitable for elderly or paediatric users. The use of breath-actuated MDIs or add-on devices such as spacers or valved holding chambers (VHCs) can...
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Inhaler Testing Dry Powder Inhalers (DPIs) As the name suggests, with a DPI the medication comes in the form of a dry powder, rather than a liquid. Typically, the active pharmaceutical ingredient(s) is mixed with a coarser excipient, such as lactose, to which it attaches. During aerosolisation the active is stripped from the carrier and inhaled whilst the carrier particles impact on the mouth and throat and are ingested. However, their relatively high cost and reliance on inhalation strength and duration are potential drawbacks. Passive The majority of DPIs are passive devices, that is to say...
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Orally Inhaled & Nasal Drug Products Nebulisers Nebulisers convert a liquid into aerosol droplets to produce a respirable cloud suitable for inhalation. They are widely used at home and in hospital and require little or no coordination for effective use. Nebulisers are normally loaded with the drug before each treatment and usually operate continuously once loaded. The main advantage of nebulisers is that their use requires little or no coordination on the part of the patient. However, they tend to be cumbersome and require either compressed air or an electrical supply. Expense, inefficiency...
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Inhaler Testing Soft Mist Inhalers (SMIs) Both MDIs and DPIs suffer from the same two inherent problems: low lung deposition (typically 5-20%) and dose variability (often due to patient difficulties in coordination or inspiration). SMIs (often known as “Inhalation Metered Sprays’’ or “Aqueous Droplet Inhalers”) actively aerosolise the liquid, forming a ‘soft mist’ to overcome these problems. These inhalers generally deliver a higher fine particle fraction than MDIs or DPIs. However, as with any multi-dose liquid system, microbial contamination can be a problem. SMIs do not use a propellant to...
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Orally Inhaled & Nasal Drug Products Applications of OINDPs Pulmonary and nasal delivery offers a number of advantages compared to traditional oral and parenteral (subcutaneous injection) routes: Directly targets the site of action Rapid onset of drug action Drugs effective in relatively low doses Fewer side effects Avoids first pass metabolism Non-invasive administration Such drugs include treatments for diverse applications such as diabetes, erectile dysfunction, migraine, osteoporosis and for vaccine delivery. Orally Inhaled Drug Product Applications Orally inhaled drugs are becoming increasingly...
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Inhaler Testing The ultimate responsibility for the safety, quality and efficacy of medicines and medical devices lies with the various national regulatory bodies designated to safeguard public health. At present, there are no worldwide standards that are specifically applicable to OINDPs. In the European Union, the responsibility for the regulation of medicines and medical devices lies with the European Medicines Agency (EMA) in the form of the Committee for Medicinal Products for Human Use (CHMP). The EMA was set up in 1995 to harmonise the work of existing national regulatory bodies in Europe....
Open the catalog to page 12All Copley Scientific catalogs and technical brochures
Gentle Rocker GR 200i2 Pages
Impactor Coater™ IC 200i2 Pages
Impactor Genie™ IG 200i4 Pages
Flow Rate Sensor FRS2 Pages
EnviroMate™8 Pages
Label Printer2 Pages
Inhalytix®+ Brochure12 Pages
Archived catalogs
Copley-Inhaler-Testing-Brochure150 Pages
Download Air Sampling Brochure40 Pages
Pharmaceutical Testing76 Pages
Inhaler Testing Brochure132 Pages
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