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Copley Catalog Inhaler Testing Brochure
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Copley Catalog Inhaler Testing Brochure
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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 Overview
The document provides a comprehensive guide to testing various inhaler types, including metered-dose inhalers (MDIs), dry powder inhalers (DPIs), nebulisers, soft mist inhalers (SMIs), and nasal products. It covers the aerodynamic particle size distribution, delivered dose uniformity, and the use of realistic breathing profiles and models.
The document provides a comprehensive guide to testing various inhaler types, including metered-dose inhalers (MDIs), dry powder inhalers (DPIs), nebulisers, soft mist inhalers (SMIs), and nasal products. It covers the aerodynamic particle size distribution, delivered dose uniformity, and the use of realistic breathing profiles and models.
Types of Inhalers
- Metered-Dose Inhalers (MDIs): Require coordination for optimal use, with options like breath-actuated MDIs and spacers to aid users.
- Dry Powder Inhalers (DPIs): Deliver medication in powder form, often requiring patient inhalation strength, with active DPIs available for improved dose accuracy.
- Nebulisers: Convert liquid medication into aerosol, requiring minimal patient coordination but can be cumbersome and costly.
- Soft Mist Inhalers (SMIs): Provide a higher fine particle fraction without using propellants, addressing issues of lung deposition and dose variability.
- Nasal Products: Include sprays, aerosols, and powders, offering multi-dose and unit-dose options for various applications.
Regulatory and Standards Compliance
The document outlines compliance with global regulatory standards and pharmacopoeias, including the European Pharmacopoeia, United States Pharmacopeia, Chinese Pharmacopoeia, and Japanese Pharmacopoeia. It also highlights the role of expert groups and international standards organizations.
The document outlines compliance with global regulatory standards and pharmacopoeias, including the European Pharmacopoeia, United States Pharmacopeia, Chinese Pharmacopoeia, and Japanese Pharmacopoeia. It also highlights the role of expert groups and international standards organizations.
Applications of OINDPs
Orally inhaled and nasal drug products (OINDPs) are increasingly used for local and systemic therapy, offering advantages over traditional oral and parenteral routes. They are used for a wide range of treatments, including diabetes, migraine, and vaccine delivery.
Orally inhaled and nasal drug products (OINDPs) are increasingly used for local and systemic therapy, offering advantages over traditional oral and parenteral routes. They are used for a wide range of treatments, including diabetes, migraine, and vaccine delivery.
Introduction
This document discusses the potential and current applications of nasal and inhalation drug delivery systems, highlighting their advantages, regulatory frameworks, and the role of various organizations in ensuring drug safety, quality, and efficacy.
This document discusses the potential and current applications of nasal and inhalation drug delivery systems, highlighting their advantages, regulatory frameworks, and the role of various organizations in ensuring drug safety, quality, and efficacy.
Drug Delivery Systems
Nasal and inhalation routes offer rapid drug absorption and direct targeting of the central nervous system, potentially treating conditions like Alzheimer's disease. These methods provide benefits such as fewer side effects, rapid onset, and non-invasive administration. Inhalation is particularly useful for treating lung diseases like asthma and COPD.
Nasal and inhalation routes offer rapid drug absorption and direct targeting of the central nervous system, potentially treating conditions like Alzheimer's disease. These methods provide benefits such as fewer side effects, rapid onset, and non-invasive administration. Inhalation is particularly useful for treating lung diseases like asthma and COPD.
Regulatory Framework
Regulatory bodies such as the EMA, FDA, and others in China and Japan oversee the safety and efficacy of inhaled and nasal products. The EMA provides guidelines on pharmaceutical quality and clinical documentation for these products. The FDA has issued guidelines for metered-dose inhalers and dry powder inhalers, focusing on quality and performance.
Regulatory bodies such as the EMA, FDA, and others in China and Japan oversee the safety and efficacy of inhaled and nasal products. The EMA provides guidelines on pharmaceutical quality and clinical documentation for these products. The FDA has issued guidelines for metered-dose inhalers and dry powder inhalers, focusing on quality and performance.
International Harmonisation
The ICH promotes harmonisation of drug regulation to ensure safety and efficacy. It has developed guidelines on pharmaceutical development, quality risk management, and manufacturing practices. The ICH Q10 guideline outlines a Pharmaceutical Quality System covering the entire product lifecycle.
The ICH promotes harmonisation of drug regulation to ensure safety and efficacy. It has developed guidelines on pharmaceutical development, quality risk management, and manufacturing practices. The ICH Q10 guideline outlines a Pharmaceutical Quality System covering the entire product lifecycle.
Pharmacopoeias
Pharmacopoeias in the EU, USA, China, and Japan set standards for medicines. They provide guidelines for testing inhalation and nasal products, ensuring compliance with quality and performance standards.
Pharmacopoeias in the EU, USA, China, and Japan set standards for medicines. They provide guidelines for testing inhalation and nasal products, ensuring compliance with quality and performance standards.
Industry Organizations
Groups like the European Pharmaceutical Aerosol Group and the International Pharmaceutical Consortium on Regulation and Science work to establish best practices and standards for inhalation products.
Groups like the European Pharmaceutical Aerosol Group and the International Pharmaceutical Consortium on Regulation and Science work to establish best practices and standards for inhalation products.
Overview: The document provides a comprehensive guide on the standards, guidelines, and testing procedures for Orally Inhaled and Nasal Drug Products (OINDPs). It highlights the collaboration between regulatory bodies, industry, and academia to ensure the safety, quality, and efficacy of these products.
Main Components of OINDPs:
- Drug Formulation: The active pharmaceutical ingredients (API) and excipients.
- Medical Device: The device that delivers the formulation to the patient, with standards defined by ISO.
Relevant Standards:
- ISO 20072: Design verification for aerosol drug delivery devices.
- ISO 27427: Standards for nebulizing systems.
Regulatory Guidelines:
- EMA Guidelines: Focus on pharmaceutical quality and clinical documentation for inhalation and nasal products.
- FDA Guidance: Quality considerations for MDIs and DPIs, and guidelines for nasal sprays and inhalation solutions.
Pharmacopoeia Standards:
- European Pharmacopoeia: Includes dosage forms and aerodynamic assessment of fine particles.
- US Pharmacopeia: Covers general information and product quality tests for inhalation and nasal drug products.
- Chinese and Japanese Pharmacopoeias: Standards for dose uniformity and particle size distribution.
Expert Groups:
- EPAG: European group focused on inhaled and nasal drug products.
- IPAC-RS: US-based group involved in regulation and science of inhaled products.
- PQRI: Collaborative research organization involving FDA’s CDER.
Inhaler Testing:
- Delivered Dose Uniformity (DDU): Ensures consistent API dosage delivery. Tests are conducted to assess inter-batch and intra-dose consistency.
- Testing Apparatus: DUSA for MDIs and DPIs, with specific setups for different inhaler types.
- Automated Systems: Vertus III and III+ automate dose collection and waste management, enhancing testing efficiency.
Conclusion: The document outlines the critical quality attributes and testing methodologies necessary to ensure the efficacy and safety of OINDPs, emphasizing the importance of international standards and collaborative efforts in the pharmaceutical industry.
Overview: The document provides detailed information on various devices and systems used for testing inhalers and nasal sprays, focusing on dose collection, waste collection, and automation to ensure consistency and accuracy in testing.
Specifications: The document outlines the specifications for different components such as the Breath Simulator BRS 100i, DecaVertus III, and various dose collection devices. It highlights the compatibility of these devices with existing systems like Vertus III/III+ and their role in ensuring reproducible and controlled testing conditions.
Procedures: Detailed procedures for dose collection and waste collection are provided, emphasizing the importance of maintaining vertical orientation to replicate in vivo usage. The document also describes the automation of these processes to reduce variability and improve data integrity.
Standards and Guidelines: The document references standards from Ph. Eur. 0676 and USP <601> for inhaler and nasal spray testing. It discusses the regulatory requirements for delivered dose uniformity (DDU) and the importance of adhering to these guidelines for accurate testing results.
Recommendations: Recommendations include using automated systems like Vertus III+ for dose collection to minimize manual errors and improve productivity. The document also suggests using specific collectors like the NSDC and NSWC for accurate dose and waste collection.
Key Devices and Components:
- DecaVertus III: An automated system for high-throughput shake and fire testing.
- Dose Uniformity Sampling Apparatus (DUSA): Used for measuring delivered dose uniformity in nasal drug products.
- Nasal Spray Dose Collector (NSDC): Designed to enhance accuracy in nasal spray testing by minimizing sample loss.
- Waste Shot Collector (WSC2): Ensures consistent waste collection under controlled conditions.
Automation and Integration: The document emphasizes the integration of automated systems to streamline testing processes, reduce manual intervention, and enhance safety by minimizing repetitive strain injuries.
Conclusion: The document provides comprehensive guidance on the equipment and methodologies for testing inhalers and nasal sprays, highlighting the importance of automation and adherence to regulatory standards to ensure accurate and reliable results.
Overview: The document provides detailed information on various systems and components used for testing Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs). It covers specifications, procedures, and guidelines for ensuring the accuracy and reliability of inhaler testing, as well as the equipment and services offered to support these processes.
Specifications and Equipment: The document describes the Waste Shot Collector WSC2, which captures aerosols from inhalers for safe disposal, and the Switching Valve for redirecting airflow. The Vertus® III and DecaVertus® III systems automate MDI testing, offering control over shaking, firing, and shot waste collection. The DTS 100i automates drug dissolution and recovery, while the Breathing Simulator BRS 200i provides realistic breathing profiles for testing MDIs with spacers or VHCs.
Testing Procedures: Delivered Dose Uniformity (DDU) testing is emphasized, with specific setups for MDIs and DPIs. For MDIs, the document highlights the importance of using breathing simulators and mouthpiece adapters to replicate patient conditions. DPI testing requires additional components like a Critical Flow Controller to manage flow conditions due to the passive nature of these devices.
Regulations and Guidelines: The document outlines various regulatory requirements for DDU testing, including guidelines from the FDA, USP, EMA, and other international bodies. It specifies the number of inhalers and criteria for different test tiers, ensuring compliance with standards for accuracy and reliability.
Training and Support: Copley offers comprehensive services, including product design, installation, training, and technical support, to optimize pharmaceutical testing processes. The document also mentions the availability of custom mouthpiece adapters and environmental control solutions to enhance test accuracy.
Key Takeaways: The document provides a thorough guide to inhaler testing, emphasizing the need for precise equipment and adherence to regulatory standards. It highlights the benefits of automation in increasing productivity and reducing errors, and offers solutions for both manual and automated testing setups.
Custom Mouthpiece Adapters: Available upon request for specific needs.
Waste Shot Collector WSC2: A compact vacuum filtration system designed to capture aerosols from inhalers for safe disposal. It is used with a Switching Valve to redirect airflow for dose wasting, necessary for multi-dose devices.
Inhaler Testing: Includes Delivered Dose Uniformity (DDU) testing for Dry Powder Inhalers (DPIs) and Nebulisers. Tests should cover the entire contents of DPI reservoir type devices.
Qualification: Compliance with GMP regulations is required, with Copley providing necessary documentation and tools.
Automation Tools: The DTS 100i automates the rinsing of DUSA collection tubes for efficient drug dissolution and recovery.
Training, Servicing & Support: Comprehensive services are offered, including product design, installation, training, and technical support.
Nebuliser Testing: Delivered dose testing determines the total drug amount a patient receives. Testing involves capturing the active substance delivery rate and total active substance delivered using filters.
Breathing Simulator Specifications: Different profiles for adults, neonates, infants, and children are specified for nebuliser characterisation tests.
Regulations and Guidelines: Various pharmacopoeias and guidelines specify tests for nebulisers, including drug delivery rate and total drug delivered.
Soft Mist Inhalers (SMIs): DDU testing is similar to MDIs, conducted at a constant flow rate. The setup includes a vacuum pump, breath actuation controller, and other components.
Nasal Sprays: DDU testing requires actuation in a vertical position with controlled parameters. Automated systems like Vertus III simplify testing.
Specifications and Procedures
The document outlines various systems and tools for testing nasal sprays and inhalers, focusing on Delivered Dose Uniformity (DDU). It highlights the NSDC manual test system for nasal sprays and the Vertus III for nasal aerosols, emphasizing automation and efficiency in testing processes. The DTS 100i automates internal rinsing for drug dissolution and recovery, enhancing testing capacity and reducing errors.
The document outlines various systems and tools for testing nasal sprays and inhalers, focusing on Delivered Dose Uniformity (DDU). It highlights the NSDC manual test system for nasal sprays and the Vertus III for nasal aerosols, emphasizing automation and efficiency in testing processes. The DTS 100i automates internal rinsing for drug dissolution and recovery, enhancing testing capacity and reducing errors.
Regulations and Guidelines
The document references guidelines from EMA, Ph. Eur., FDA, and USP for DDU testing of nasal aerosols and powders. It stresses the importance of meeting regulatory standards for accuracy and reliability in pharmaceutical testing.
The document references guidelines from EMA, Ph. Eur., FDA, and USP for DDU testing of nasal aerosols and powders. It stresses the importance of meeting regulatory standards for accuracy and reliability in pharmaceutical testing.
Training, Servicing & Support
A comprehensive range of services is offered, including product design, installation, training, and technical support, to optimize pharmaceutical testing.
A comprehensive range of services is offered, including product design, installation, training, and technical support, to optimize pharmaceutical testing.
Environmental Control Solutions
Solutions are provided to improve the accuracy, sensitivity, and reproducibility of test data, considering environmental variability.
Solutions are provided to improve the accuracy, sensitivity, and reproducibility of test data, considering environmental variability.
Automation Tools
The document details automation tools like the DTS 100i and Vertus III, which improve testing efficiency and accuracy by reducing handling errors and increasing testing capacity.
The document details automation tools like the DTS 100i and Vertus III, which improve testing efficiency and accuracy by reducing handling errors and increasing testing capacity.
Inhaler Testing
Testing for nasal aerosols and powders is discussed, with emphasis on the importance of aerodynamic particle size distribution (APSD) for drug efficacy. Cascade impactors are highlighted as the preferred tool for measuring APSD due to their ability to capture the entire dose and provide API-specific measurements.
Testing for nasal aerosols and powders is discussed, with emphasis on the importance of aerodynamic particle size distribution (APSD) for drug efficacy. Cascade impactors are highlighted as the preferred tool for measuring APSD due to their ability to capture the entire dose and provide API-specific measurements.
Qualification
GMP regulations require proper qualification documentation and services, which are provided to ensure compliance with testing standards.
GMP regulations require proper qualification documentation and services, which are provided to ensure compliance with testing standards.
Introduction
This document provides a detailed overview of the use and operation of cascade impactors for aerodynamic particle size distribution (APSD) testing in inhaler devices. It covers the principles of operation, types of cascade impactors, and their applications in quality control and in-vitro bioequivalence testing.
This document provides a detailed overview of the use and operation of cascade impactors for aerodynamic particle size distribution (APSD) testing in inhaler devices. It covers the principles of operation, types of cascade impactors, and their applications in quality control and in-vitro bioequivalence testing.
Specifications and Components
The cascade impactor is a precision instrument used to separate aerosol particles into size fractions. It consists of multiple stages arranged in a stack, each with nozzles that direct particles onto collection plates. The document describes various components such as the induction port, vacuum pump, and collection cups, highlighting the importance of maintaining a fixed volumetric flow rate for accurate particle sizing.
The cascade impactor is a precision instrument used to separate aerosol particles into size fractions. It consists of multiple stages arranged in a stack, each with nozzles that direct particles onto collection plates. The document describes various components such as the induction port, vacuum pump, and collection cups, highlighting the importance of maintaining a fixed volumetric flow rate for accurate particle sizing.
Types of Cascade Impactors
The document details different types of cascade impactors, including the Next Generation Impactor (NGI) and Andersen Cascade Impactor (ACI). The NGI is noted for its flexibility and precision, suitable for a wide range of flow rates and testing applications. The ACI, with a vertical layout, is well-established for APSD characterization and offers options for high flow rate testing.
The document details different types of cascade impactors, including the Next Generation Impactor (NGI) and Andersen Cascade Impactor (ACI). The NGI is noted for its flexibility and precision, suitable for a wide range of flow rates and testing applications. The ACI, with a vertical layout, is well-established for APSD characterization and offers options for high flow rate testing.
Operation and Data Analysis
Cascade impactors operate by directing airborne particles through nozzles onto collection plates, where they are separated by size. The document explains the process of recovering and analyzing particle mass using chemical methods like HPLC. It also introduces Inhalytix®, a software solution for automating APSD data analysis.
Cascade impactors operate by directing airborne particles through nozzles onto collection plates, where they are separated by size. The document explains the process of recovering and analyzing particle mass using chemical methods like HPLC. It also introduces Inhalytix®, a software solution for automating APSD data analysis.
Maintenance and Best Practices
Regular maintenance, including mensuration, leak testing, and cleaning, is emphasized to ensure the accuracy and longevity of the impactors. The document provides guidelines for these practices and mentions available servicing options.
Regular maintenance, including mensuration, leak testing, and cleaning, is emphasized to ensure the accuracy and longevity of the impactors. The document provides guidelines for these practices and mentions available servicing options.
Accessories and Enhancements
A range of accessories is available to enhance the functionality of cascade impactors, including rinsing caps, carrying racks, and storage cabinets. The document also discusses the NGI Cooler™ and various sample collection cups designed for specific testing needs.
A range of accessories is available to enhance the functionality of cascade impactors, including rinsing caps, carrying racks, and storage cabinets. The document also discusses the NGI Cooler™ and various sample collection cups designed for specific testing needs.
Conclusion
Cascade impactors are critical tools in inhaler testing, providing precise and reproducible measurements of particle size distribution. The document underscores their importance in ensuring product quality and regulatory compliance.
Cascade impactors are critical tools in inhaler testing, providing precise and reproducible measurements of particle size distribution. The document underscores their importance in ensuring product quality and regulatory compliance.
Overview: The document provides detailed technical specifications and operational guidelines for the Andersen Cascade Impactor (ACI) and other related inhaler testing equipment. It includes information on configurations, accessories, and testing methodologies for various inhaler types.
Specifications:
- Flow Rate Range: Standard ACI operates at 28.3 L/min, with modified configurations available for 60 and 90 L/min.
- Particle Size Range: Varies with flow rate: 0.4 - 9.0 microns (28.3 L/min), 0.3 - 8.6 microns (60 L/min), 0.2 - 8.0 microns (90 L/min).
- Number of Stages: 8 stages for ACI.
- Materials: Aluminium, 316 Stainless Steel, or Titanium.
Operation and Components:
- The ACI uses impaction to separate particles by size across multiple stages, with each stage having specific cut-off diameters depending on the flow rate.
- Accessories include induction ports, quick clamps, preseparators, and collection plate racks, designed to enhance testing efficiency and accuracy.
Testing Procedures:
- ACI is used for aerodynamic particle size distribution (APSD) testing of inhalers, crucial for ensuring drug delivery efficiency.
- Testing involves chemical analysis methods such as HPLC, UPLC, and IR.
Alternative Equipment:
- Multi-Stage Liquid Impinger (MSLI): Features four impaction stages and a final filter stage, with no inter-stage losses and moist collection stages to prevent particle bounce.
- Glass Twin Impinger (GTI): Used for routine quality control, operates at 60 L/min, and divides doses into respirable and non-respirable portions.
Regulations and Guidelines:
- Compliance with Ph.Eur., USP, ChP, and JP standards for various inhaler types, including MDIs, DPIs, and nasal products.
Conclusion: The document provides comprehensive guidance on the use of ACI and related equipment for inhaler testing, emphasizing precision, reproducibility, and compliance with international standards.
Overview: The document provides detailed information on various equipment and systems used for inhaler testing, focusing on the Low Capacity Pump LCP6, Flow Rate Sensor FRS, Inhaler Testing Workstation ITW, and other related tools. It emphasizes the importance of meeting pharmacopoeial requirements and improving testing accuracy and efficiency.
Vacuum Pump Technology: The Low Capacity Pump LCP6 is highlighted as a high-performance, low-maintenance vacuum pump designed for testing orally inhaled and nasal drug products (OINDPs). It ensures compliance with pharmacopoeial requirements and is suitable for different flow rates depending on the target demographic (adults or children).
Flow Rate Measurement: The Flow Rate Sensor FRS is used to establish accurate and consistent inlet flow rates during testing, adhering to pharmacopoeial accuracy standards.
Inhaler Testing Workstation: The ITW is designed to organize testing apparatus, holding the cascade impactor and flow meter in place to improve workflow efficiency.
Mouthpiece Adapters: These adapters ensure an airtight seal between the inhaler and test apparatus, available in various sizes and customizable upon request.
Automated Test Systems: The Vertus III and Vertus III+ systems offer automated solutions for MDI testing, providing control over shaking, firing force, and timing to enhance testing accuracy and reproducibility.
Data Analysis Software: Inhalytix automates the transformation of raw inhaler testing data into performance metrics, supporting data entry, analysis, and reporting for all inhaled products.
Regulations and Guidelines: The document references various pharmacopoeial guidelines and regulations, emphasizing the need for compliance in testing procedures.
Additional Equipment and Support: The document mentions additional equipment for specific testing applications, as well as comprehensive training, servicing, and support services to optimize pharmaceutical testing processes.
Conclusion: The document provides a comprehensive overview of the tools and systems available for inhaler testing, highlighting their features, applications, and compliance with regulatory standards to ensure accurate and efficient testing processes.
Inhaler Testing Workstation™
This section discusses the Inhaler Testing Workstation, which is recommended for establishing accurate and consistent inlet flow rates during testing. The Flow Rate Sensor (FRS) is highlighted for its precision in measuring flow rates as specified by pharmacopoeias.
This section discusses the Inhaler Testing Workstation, which is recommended for establishing accurate and consistent inlet flow rates during testing. The Flow Rate Sensor (FRS) is highlighted for its precision in measuring flow rates as specified by pharmacopoeias.
Mouthpiece Adapter
Mouthpiece Adapters are essential for ensuring an airtight seal between the inhaler and the test apparatus. They are made from high-quality silicone rubber, and custom adapters are available upon request.
Mouthpiece Adapters are essential for ensuring an airtight seal between the inhaler and the test apparatus. They are made from high-quality silicone rubber, and custom adapters are available upon request.
Automation Tools
The Impactor Coater™ IC 200i standardizes the coating of impaction surfaces, improving efficiency and reducing variability. The Inhalytix® software automates the transformation of raw inhaler testing data into performance metrics, ensuring secure and compliant data processing.
The Impactor Coater™ IC 200i standardizes the coating of impaction surfaces, improving efficiency and reducing variability. The Inhalytix® software automates the transformation of raw inhaler testing data into performance metrics, ensuring secure and compliant data processing.
Qualification and GMP Regulations
GMP regulations require that pharmaceutical testing methods meet standards of accuracy and reliability. Copley provides qualification documentation and services to meet these requirements.
GMP regulations require that pharmaceutical testing methods meet standards of accuracy and reliability. Copley provides qualification documentation and services to meet these requirements.
Aerodynamic Particle Size Distribution (APSD)
The document details the APSD testing for nebulisers and SMIs, emphasizing the importance of maintaining proper environmental conditions to ensure accurate measurements. The NGI Cooler™ is used to control the temperature during testing.
The document details the APSD testing for nebulisers and SMIs, emphasizing the importance of maintaining proper environmental conditions to ensure accurate measurements. The NGI Cooler™ is used to control the temperature during testing.
Training, Servicing & Support
A comprehensive range of services is offered, including product design, installation, training, and technical support to optimize pharmaceutical testing processes.
A comprehensive range of services is offered, including product design, installation, training, and technical support to optimize pharmaceutical testing processes.
Breathing Simulator Models
The BRS 100i and BRS 200i models offer features like touchscreen interfaces, extensive data output options, and compliance with regulatory standards. They support various testing applications and provide 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 regulatory standards. They support various testing applications and provide user management features to ensure data compliance.
Overview: The document provides detailed information on the Breathing Simulator models BRS 200i and BRS 300i, along with their accessories and compliance with various standards. It also covers the testing procedures for inhalers, including MDIs, DPIs, and nebulisers, and the importance of flow control in these tests.
Specifications: The BRS 200i and BRS 300i simulators are designed for inhaler testing, featuring a powerful drive system, touchscreen interface, and extensive data output options. They comply with Ph. Eur. 2.9.44, 21 CFR Part 11, ISO 27427:2013, and USP <1601> and <1602> standards.
Key Features: The simulators offer intuitive touchscreen controls, compatibility with various sensors, and the ability to store and recall methods. They support both inhalation and exhalation profiles and provide real-time breath verification.
Accessories: Accessories include temperature and humidity sensors, MDI actuation sensors, footswitches, and qualification kits. Extended warranties and re-calibration services are available.
Inhaler Testing Procedures: The document outlines the importance of controlling flow rate and volume during inhaler testing to meet regulatory requirements. It describes the use of flow controllers and solenoid valves to simulate patient inhalation conditions accurately.
Flow Control: Critical flow control is essential for DPI testing due to their passive nature. The document explains how to achieve stable flow conditions and the significance of maintaining a pressure drop of 4 kPa during testing.
Data Reporting: The simulators provide extensive data output options, including direct reporting to PCs and USB devices. Reports include method, run, and audit reports, detailing various test parameters and user actions.
Compliance and Maintenance: The document emphasizes compliance with Ph. Eur. and USP standards and offers comprehensive IQ/OQ documentation and toolkits for qualification and maintenance.
Overview: The document provides detailed information on the TPK 100i and TPK 100i-R flow controllers, 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 for inhaler testing. They feature automated flow control, 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 includes a resistive touchscreen, manual and automated flow settings, and capabilities for temperature and humidity measurement. It supports critical flow control with solenoid valve operation times of 25 ms and a timer range of 0-600 seconds.
Accessories: Accessories include a footswitch for device actuation synchronization, MDI actuation sensors, and various data output options. 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: Different models of vacuum pumps (LCP6, HCP6, SCP6) are available for testing various inhaler types. These pumps feature low maintenance, advanced cooling, and sound insulation.
Environmental Control: The document emphasizes the importance of controlling environmental conditions such as temperature, humidity, and electrostatic charge to ensure accurate inhaler testing results.
Overview: The document provides a detailed description of the EnviroMate™ system, designed for inhaler testing, focusing on maintaining stable environmental conditions to improve data accuracy, sensitivity, and reproducibility. It highlights the importance of controlling temperature, humidity, and electrostatic charge during testing.
Key Features:
- EnviroMate™ is a compact, benchtop solution that ensures uniform temperature and humidity, minimizing electrostatic charge effects.
- It is energy-efficient and requires no routine maintenance, offering a cost-effective alternative to dedicated environmental control rooms.
- The system is compliant with Ph. Eur. and USP standards.
Technical Specifications:
- Temperature Control Range: 17 - 35ºC with an accuracy of ±2ºC.
- Humidity Control Range: 15 - 85% RH with an accuracy of ±5% RH.
- Includes an electrostatic minimization system and various ancillary connector ports.
Performance Data: The document includes a performance envelope graph illustrating the optimal temperature and humidity ranges achievable by EnviroMate™.
Ancillaries and Accessories:
- Anti-Static Grounding Kit, Digital Static Meter, and Electrostatic Eliminator to manage electrostatic charge.
- NGI Cooler™ for nebuliser testing, maintaining precise temperature control to prevent evaporation-related issues.
- Inhaler Testing Workstation™ ITW for flexible and efficient handling of test apparatus.
- Glass Expansion Chambers for measuring drug particle deposition in nasal sprays.
Additional Tools: The document lists various adapters and connectors to ensure proper interfacing between testing components, emphasizing the importance of maintaining data integrity.
Inhaler Devices and Accessories
This section lists various inhaler devices such as Turbuhaler, Diskhaler, Respimat, and others, along with accessories like mouthpiece adapters and support accessories. These accessories ensure proper positioning and organization during testing. Custom adapters are available for specific testing needs, and certificates of conformance are provided for materials used.
This section lists various inhaler devices such as Turbuhaler, Diskhaler, Respimat, and others, along with accessories like mouthpiece adapters and support accessories. These accessories ensure proper positioning and organization during testing. Custom adapters are available for specific testing needs, and certificates of conformance are provided for materials used.
Nasal Adapters
Custom nosepiece adapters are available for nasal devices to ensure a perfect fit with testing equipment. These adapters create airtight seals necessary for accurate testing of nasal drug delivery systems.
Custom nosepiece adapters are available for nasal devices to ensure a perfect fit with testing equipment. These adapters create airtight seals necessary for accurate testing of nasal drug delivery systems.
Inhaler Testing and Inhalytix Software
The Inhalytix software is designed for the analysis of aerodynamic particle size distribution (APSD) in inhaled and nasal drug products. It complies with USP and Ph.Eur. standards and supports various cascade impactors. The software offers a flexible, validated solution for data entry, analysis, and reporting, with features like user-configurable test methods and equipment inventory management.
The Inhalytix software is designed for the analysis of aerodynamic particle size distribution (APSD) in inhaled and nasal drug products. It complies with USP and Ph.Eur. standards and supports various cascade impactors. The software offers a flexible, validated solution for data entry, analysis, and reporting, with features like user-configurable test methods and equipment inventory management.
System Characteristics and Operation
The software provides a dashboard for system monitoring, supports custom impactor configurations, and allows for detailed test method creation. It facilitates the preparation, execution, and analysis of tests, ensuring data integrity and traceability.
The software provides a dashboard for system monitoring, supports custom impactor configurations, and allows for detailed test method creation. It facilitates the preparation, execution, and analysis of tests, ensuring data integrity and traceability.
Improving In Vitro-In Vivo Correlations (IVIVCs)
Enhancing the clinical realism of in vitro tests can bridge the gap between quality control testing and in vivo performance. The document discusses the challenges of predicting pharmacokinetic and pharmacodynamic properties and the importance of robust IVIVCs for demonstrating bioequivalence and supporting Quality by Design (QbD) initiatives.
Enhancing the clinical realism of in vitro tests can bridge the gap between quality control testing and in vivo performance. The document discusses the challenges of predicting pharmacokinetic and pharmacodynamic properties and the importance of robust IVIVCs for demonstrating bioequivalence and supporting Quality by Design (QbD) initiatives.
Regulatory Guidance and Clinical Relevance
The FDA's draft guidance for Beclomethasone Dipropionate aerosol highlights novel in vitro testing approaches to improve clinical realism and IVIVCs. The document emphasizes the need for clinically relevant in vitro tests and in silico models to support the development of generic OINDPs.
The FDA's draft guidance for Beclomethasone Dipropionate aerosol highlights novel in vitro testing approaches to improve clinical realism and IVIVCs. The document emphasizes the need for clinically relevant in vitro tests and in silico models to support the development of generic OINDPs.
Overview: The document discusses the assessment of Critical Quality Attributes (CQAs) for inhaled drug formulations, focusing on patient, device, and formulation aspects to enhance understanding and demonstrate bioequivalence. It emphasizes the importance of realistic testing conditions to improve in vitro-in vivo correlations (IVIVCs) and drug delivery efficiency.
Key Sections:
- Demonstrating Bioequivalence (BE): The document outlines the regulatory guidance for demonstrating bioequivalence between test and reference formulations, highlighting the importance of understanding CQAs related to patient, device, and formulation.
- Improving IVIVCs: Methods to improve IVIVCs include using realistic breathing profiles and throat/nasal models to better simulate human conditions during testing. This section stresses the need for more representative testing conditions to enhance drug delivery assessments.
- DDU and APSD Testing: The document discusses the significance of dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing in ensuring batch consistency and predicting bioavailability. It also highlights the role of in vitro dissolution testing in drug development.
- Realistic Breathing Profiles: The use of breathing simulators to generate realistic profiles is recommended to improve the clinical relevance of DDU and APSD testing, particularly for passive devices like dry powder inhalers (DPIs).
- Realistic Throat and Nasal Models: The document describes the development of models that mimic human anatomy to provide more accurate assessments of drug delivery to the lungs and nasal passages.
- Ancillary Equipment: Various tools and adapters are discussed, such as mixing inlets and breathing simulators, which are essential for conducting representative testing of inhaled products.
Conclusion: The document emphasizes the need for realistic testing conditions and advanced modeling to improve the assessment of inhaled drug formulations, ultimately aiding in the demonstration of bioequivalence and enhancing drug delivery efficiency.
Overview: The document provides detailed information on various components and systems used for testing inhaled drug products, focusing on improving in vitro-in vivo correlations (IVIVCs). It covers equipment for aerosol particle size distribution (APSD) measurement, dissolution testing, and facemask performance assessment.
Key Components and Systems:
- Alberta Idealised Throat (AIT) and Nasal Inlet (AINI): These models simulate drug deposition in the nasal and throat regions, aiding in the evaluation of drug absorption and unintended lung transit.
- Breathing Simulator BRS: Used for simulating patient breath profiles during testing.
- Cascade Impactors: Essential for APSD measurement, with various models available based on device type.
- Vacuum Pump and Critical Flow Controller TPK 100i: Ensure consistent flow conditions during testing.
- NGI Cooler and Flow Rate Sensor FRS: Maintain temperature control and measure flow rates accurately.
Dissolution Testing: The document highlights the challenges of designing standardised dissolution tests for inhaled drugs due to the small amount of lung fluid and presence of surfactants. It discusses the use of NGI Dissolution Cups and Andersen Cascade Impactor (ACI) for particle selection and dose collection.
Facemask Testing: Emphasizes the importance of facemask fit in drug delivery, especially for infants and children. It describes the use of face models and testing apparatus to assess facemask performance.
Qualification and Standards: The document stresses the need for accurate and reliable test methods, adhering to GMP regulations, and provides qualification documentation and services.
Facemask Testing Apparatus (FMA) and Breathing Simulators: The document outlines the components required for a fully operational DDU test system to assess the impact of facemasks on the performance of MDIs with a Spacer/VHC. Key components include the Facemask Testing Apparatus (FMA), Filter Holder & Adapter, Face Model, and Breathing Simulator models BRS 100i and BRS 200i. The FMA is designed to meet critical requirements for assessing facemask impact on MDIs, with models available for all age groups featuring replaceable face skins for realistic testing.
Flow Controllers and Ancillaries: Flow Controllers are essential for setting flow rates and sampling time delays, improving testing reproducibility and method transfer. The document emphasizes the importance of accurate flow rate measurement, with references to further information on page 184.
Facemask Testing Stand (FMS) for Nebulisers: The FMS is designed to assess the effect of facemasks on nebulisers, with models available for different age groups. The Breathing Simulator BRS 200i provides clinically representative breathing profiles, while the BRS 100i offers a basic entry-level option. The document highlights the need for a fully operational DDU test system, including the FMS, Face Model, and Breathing Simulator.
APSD Measurement and Qualification: The APSD characterization of facemask performance should be conducted using an NGI. The document stresses the importance of meeting GMP regulations and provides information on qualification documentation and services.
Cold Freon® Effect and Spray Testing: The document discusses the cold Freon® effect, which can influence drug delivery efficiency. It highlights the importance of assessing spray force and plume temperature to evaluate potential adverse reactions. The Spray Force Tester SFT 1000 and Plume Temperature Tester PTT 1000 are described, with technical specifications and key features provided.
Special Applications and Morphology: The document touches on the use of cascade impactors for APSD and morphological analysis, emphasizing the importance of understanding particle size and shape for bioavailability and generic development.
Introduction
The document discusses the application of Abbreviated Impactor Measurement (AIM) in the Quality by Design (QbD) process for orally inhaled products (OIPs). AIM is highlighted as a rapid screening tool in research and development (R&D) and quality control (QC) applications, offering a more efficient alternative to full-resolution cascade impactor methods.
The document discusses the application of Abbreviated Impactor Measurement (AIM) in the Quality by Design (QbD) process for orally inhaled products (OIPs). AIM is highlighted as a rapid screening tool in research and development (R&D) and quality control (QC) applications, offering a more efficient alternative to full-resolution cascade impactor methods.
Specifications and Procedures
The document outlines the use of cascade impactors as the preferred method for measuring the aerodynamic particle size distribution (APSD) of OIPs. It introduces Efficient Data Analysis (EDA) as a method to determine product fitness using simpler metrics once a full APSD profile is established. The document also describes the use of AIM in QC and R&D, emphasizing its role in fast screening of new formulations and reducing reliance on clinical trials.
The document outlines the use of cascade impactors as the preferred method for measuring the aerodynamic particle size distribution (APSD) of OIPs. It introduces Efficient Data Analysis (EDA) as a method to determine product fitness using simpler metrics once a full APSD profile is established. The document also describes the use of AIM in QC and R&D, emphasizing its role in fast screening of new formulations and reducing reliance on clinical trials.
Norms and Recommendations
There is a focus on the development of generic OIPs as patents expire, leading to the reintroduction of original test methods in pharmacopoeias. The document stresses the importance of understanding the impact of poor patient technique on inhaler critical quality attributes (CQAs) to optimize inhaler designs.
There is a focus on the development of generic OIPs as patents expire, leading to the reintroduction of original test methods in pharmacopoeias. The document stresses the importance of understanding the impact of poor patient technique on inhaler critical quality attributes (CQAs) to optimize inhaler designs.
Device Robustness and Inhaler Misuse
Device mishandling and poor technique are identified as significant issues affecting inhaler performance. Solutions are offered to help developers understand and mitigate these impacts, thereby improving drug delivery robustness.
Device mishandling and poor technique are identified as significant issues affecting inhaler performance. Solutions are offered to help developers understand and mitigate these impacts, thereby improving drug delivery robustness.
Specialized Test Equipment
The document details various specialized test equipment for assessing the performance of orally inhaled and nasal drug products (OINDPs). It introduces different versions of abbreviated impactors, such as the Fast Screening Andersen (FSA) and Reduced NGI (rNGI), designed to speed up formulation screening and improve data comparability.
The document details various specialized test equipment for assessing the performance of orally inhaled and nasal drug products (OINDPs). It introduces different versions of abbreviated impactors, such as the Fast Screening Andersen (FSA) and Reduced NGI (rNGI), designed to speed up formulation screening and improve data comparability.
Key Features and Tools
The Volume and Resistance Compensator (VRC) is introduced as a tool to match flow resistance and flow rate rise-time profiles between full-resolution and abbreviated impactors, ensuring comparable conditions for aerosol generation.
The Volume and Resistance Compensator (VRC) is introduced as a tool to match flow resistance and flow rate rise-time profiles between full-resolution and abbreviated impactors, ensuring comparable conditions for aerosol generation.
Conclusion
The document emphasizes the potential of AIM to streamline the testing process for OIPs, offering faster and more efficient methods for both R&D and QC applications. It highlights the importance of maintaining data comparability and improving inhaler design to enhance drug delivery.
The document emphasizes the potential of AIM to streamline the testing process for OIPs, offering faster and more efficient methods for both R&D and QC applications. It highlights the importance of maintaining data comparability and improving inhaler design to enhance drug delivery.
Volume and Resistance Compensator (VRC) Performance:
The VRC is designed to manage volume and resistance in inhaler testing. Performance data is presented in terms of pressure over time, indicating its effectiveness in maintaining consistent conditions during testing.
The VRC is designed to manage volume and resistance in inhaler testing. Performance data is presented in terms of pressure over time, indicating its effectiveness in maintaining consistent conditions during testing.
Generic Drug Development and Inhaler Testing:
The FDA and USP have issued guidance and monographs for active pharmaceutical ingredients (APIs) used in asthma and COPD treatments. These guidelines emphasize the importance of using specific test equipment and methods to ensure bioequivalence with reference drugs. Key performance metrics include Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD).
The FDA and USP have issued guidance and monographs for active pharmaceutical ingredients (APIs) used in asthma and COPD treatments. These guidelines emphasize the importance of using specific test equipment and methods to ensure bioequivalence with reference drugs. Key performance metrics include Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD).
Aerodynamic Particle Size Distribution (APSD):
APSD measurements are crucial for both aerosols and powders, using an Andersen Cascade Impactor (ACI) with specific modifications. The testing involves simulating patient inhalation conditions to ensure accurate drug delivery.
APSD measurements are crucial for both aerosols and powders, using an Andersen Cascade Impactor (ACI) with specific modifications. The testing involves simulating patient inhalation conditions to ensure accurate drug delivery.
FP/Salmeterol Aerosols and Powders Testing:
Specific apparatus and procedures are outlined for testing FP/Salmeterol aerosols and powders, including the use of induction ports, inlet cones, and preseparators. The equipment ensures precise measurement of DDU and APSD.
Specific apparatus and procedures are outlined for testing FP/Salmeterol aerosols and powders, including the use of induction ports, inlet cones, and preseparators. The equipment ensures precise measurement of DDU and APSD.
Albuterol Inhalation Aerosols:
The draft monograph specifies the use of a special glass Sample Collection Apparatus for DDU testing. APSD measurement requires a modified induction port and optional inlet sleeve for compatibility with standard adapters.
The draft monograph specifies the use of a special glass Sample Collection Apparatus for DDU testing. APSD measurement requires a modified induction port and optional inlet sleeve for compatibility with standard adapters.
Patient Exhalation Simulator (PES):
The PES replicates 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 comprehensive qualification tools available.
The PES replicates 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 comprehensive qualification tools available.
Automation in Inhaler Testing:
Automation solutions, such as the Vertus III and DecaVertus III systems, enhance testing efficiency by reducing manual handling and variability. These systems support DDU and APSD testing, offering precise control over test parameters and improving data integrity.
Automation solutions, such as the Vertus III and DecaVertus III systems, enhance testing efficiency by reducing manual handling and variability. These systems support DDU and APSD testing, offering precise control over test parameters and improving data integrity.
Conclusion:
The document outlines the importance of specific testing equipment and procedures in ensuring the efficacy and safety of inhaler products. Compliance with regulatory guidelines and the use of advanced automation systems are emphasized to achieve consistent and reliable results.
The document outlines the importance of specific testing equipment and procedures in ensuring the efficacy and safety of inhaler products. Compliance with regulatory guidelines and the use of advanced automation systems are emphasized to achieve consistent and reliable results.
Overview: The document provides detailed information on the Vertus III and Vertus III+ systems, which are designed for inhaler testing, specifically focusing on the measurement of shot weight and other parameters critical for ensuring the consistency and safety of drug delivery devices.
Key Features:
- The Vertus III+ includes an integrated analytical balance for measuring shot weight, aiding in the detection of misfiring and troubleshooting.
- Automation capabilities streamline the testing process, particularly for the Uniformity of Delivered Mass as required by Ph. Eur. monograph 0676.
- The system supports the extraction of flammable propellants or high potency drugs through an exhaust port.
Technical Specifications:
- Shaking and firing parameters are fully controllable, including shake speed, angle, and duration, as well as fire force and angle.
- Airflow parameters are adjustable, ensuring precise control over testing conditions.
- The Vertus III+ offers a weight range of 0.01 mg to 200 g with a resolution of 0.01 mg.
- User interface includes a 10.1” color touchscreen, with extensive connectivity options such as Ethernet, USB, and RS-232.
Compatibility and Accessories:
- The system is compatible with MDIs, nasal aerosols, and nasal sprays, and supports various interface plates for different testing needs.
- Accessories include a priming and waste module, interface plates for MDIs and nasal sprays, and various adapters and holders for specific testing setups.
DecaVertus III:
- Designed for high-throughput testing, the DecaVertus III automates firing-to-waste for up to ten MDIs per test run, enhancing repeatability and reducing analyst workload.
- Compliant with Ph. Eur., EMA, USP, FDA, ChP, and NMPA standards, and offers extensive reporting and data output options.
Additional Systems:
- The DUSA Shaker DTS 100i automates drug recovery from DUSA collection tubes, improving efficiency and reducing variability in dose uniformity testing.
- The Impactor Coater IC 200i addresses the need for consistent coating of impactor stages to prevent particle bounce during APSD sampling.
Overview: The document provides detailed information on the Impactor Coater IC 200i, Gentle Rocker GR 200i, Impactor Genie IG 200i, Sample Preparation Unit SPU 200i, and the Impactor Cleaning System. These devices are designed to enhance the efficiency and accuracy of aerodynamic particle size distribution (APSD) testing for orally inhaled and nasal drug products (OINDPs).
IC 200i Coater: The IC 200i is used to apply surface coatings to NGI Collection Cups and ACI Collection Plates, reducing particle bounce and re-entrainment during APSD measurement. It standardizes the coating process, minimizes solution wastage, and allows easy method transfer between sites. Key features include a touchscreen interface, compatibility with various coating solutions, and extensive data output options.
GR 200i Gentle Rocker: This device aids in drug recovery by gently agitating solvents across impaction surfaces. It supports a range of drug recovery methods, freeing up analysts for other tasks and enabling easy method transfer. It features adjustable agitation speeds and an intuitive interface.
IG 200i Impactor Genie: Combining the functionalities of the IC 200i and GR 200i, the IG 200i offers a comprehensive solution for APSD impactor preparation and drug recovery. It enhances sampling repeatability and accuracy, supporting both NGI and ACI collection systems.
SPU 200i Sample Preparation Unit: The SPU 200i automates drug recovery procedures, reducing testing bottlenecks and RSI risks. It features variable speed control, intuitive touchscreen operation, and is designed for use with induction ports and preseparators.
Impactor Cleaning System: This system ensures thorough cleaning and drying of cascade impactors, maintaining optimal instrument condition. It includes ultrasonic cleaning, rinsing, aspiration, and drying components, suitable for both NGI and ACI systems.
Technical Specifications and Accessories: Each device comes with specific technical specifications, including dimensions, connectivity options, and operational parameters. Accessories and spare parts are available for each system, ensuring comprehensive support and maintenance.
Analytical Instrument Qualification (AIQ) and Analytical Method Validation (AMV): AIQ ensures that instruments are suitable for their intended application, while AMV ensures that analytical and software procedures are appropriate. Good Manufacturing Practices (GMP) regulations require accurate and reliable test methods and procedures to ensure instrument fitness. The USP provides guidance through chapters such as <1058> for AIQ and <1225> for validation of compendial procedures.
Qualification and Servicing: The USP Chapter <1058> outlines a four-phase approach to qualification: Design (DQ), Installation (IQ), Operational (OQ), and Performance (PQ). AIQ and AMV ensure analysis quality before testing, while system suitability tests ensure quality during analysis. Errors in inhaler testing can arise from human or instrument-related factors, and eliminating these errors can help identify device/formulation issues.
Impactor Qualification and Mensuration: Cascade impactors must meet criteria set by Ph. Eur. and USP. Performance depends on nozzle dimensions and airflow rate. Mensuration ensures impactors conform to specifications, replacing repetitive calibration. Copley offers mensuration services for various impactors, ensuring compliance with pharmacopoeial requirements.
Data Interpretation and Impactor Performance Restoration: Mensuration certificates detail component compliance. Regular re-mensurations are recommended to monitor compliance. Effective Diameter (ED) and In-Use Margin help determine impactor suitability. Restoration options include cleaning, pinning, or stage replacement.
Equipment Servicing and Calibration: Copley provides in-house and on-site servicing, maintenance, and calibration tailored to customer needs. Services include IQ/OQ documentation, ensuring systems are fully qualified for use.
Product Protection Plans: Copley offers a standard 12-month warranty with options for extended protection. This provides assurance of product quality and reliability.
Support and Training: Copley offers comprehensive support from purchase to after-sales. Training programs cover regulatory requirements, testing fundamentals, and core methods for OINDPs, catering to both beginners and experienced analysts.
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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 MSP, a Division of TSI catalogs and technical brochures
Inhalytix®+ Copley Brochure12 Pages
EnviroMate™ Copley Brochure5 Pages
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