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EnviroMate™ Copley Brochure

EnviroMate™ Copley Brochure

EnviroMate™ Copley Brochure

Product catalog summary
Introduction
The document discusses the EnviroMate™ Benchtop Environmental Chamber, specifically designed for testing orally inhaled and nasal drug products (OINDPs). It addresses the variability in testing due to environmental conditions such as temperature, humidity, and electrostatic charge, which can affect dose emission and aerosol generation performance.

Sources of Testing Variability
Key factors contributing to variability include:
  • Temperature and humidity fluctuations.
  • Electrostatic charge from devices and handling.
  • Particle/droplet evaporation and water absorption effects.
These factors can compromise the integrity of delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) test data.

Environmental Control
The EnviroMate™ chamber provides consistent environmental control, maintaining uniform temperature and humidity, and minimizing electrostatic charge. This enhances data accuracy and repeatability, addressing issues such as:
  • Variable laboratory conditions.
  • High sensitivity of OINDPs to environmental factors.
  • Poor reproducibility and out-of-specification results.

Key Features
EnviroMate™ offers:
  • Temperature control range: 20 - 25ºC with ±2ºC accuracy.
  • Humidity control range: 40 - 75% RH with ±5% RH accuracy.
  • Anti-static system to reduce electrostatic-induced variability.
  • Easy access and handling with large entry ports and quick-release connectors.

Applications
Besides OINDP testing, EnviroMate™ is suitable for other pharmaceutical laboratory applications, such as powder flowability and bulk/tapped density testing.

Technical Specifications
EnviroMate™ includes a digital user interface, operates at a sound level of 63 dBA, and has a capacity of 280 litres. It is powered by a mains supply of 230V, 50Hz or 115V, 60Hz.

Conclusion
EnviroMate™ is a cost-effective solution for achieving stable environmental conditions in pharmaceutical testing, enhancing the reliability and accuracy of test results.
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Catalog excerpts

EnviroMate™ Copley Brochure-1

EnviroMate™ Benchtop Environmental Chamber

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EnviroMate™ Copley Brochure-2

Inhaler Testing OINDP Testing Variability and Environmental Conditions Many factors have been identified that could give rise to variability in the testing of orally inhaled and nasal drug products (OINDPs). Each of these factors reduces the discriminatory power of tests to accurately determine product variability. Effective strategies to mitigate sources of variability in delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement have been the focus of rigorous investigation for many years. Environmental conditions is one key area. Localised changes...

 Open the catalog to page 2
EnviroMate™ Copley Brochure-3

Inhaler Testing Key Features: Sensitive temperature and relative humidity sensor ensures accurate performance Adjacent holder for BAC 100i/ TPK 100i Temperature and Relative Humidity Sensor included Anti-static system minimises electrostaticinduced variability Internal light maximises visibility Inadequate control of environmental conditions can affect the dose emission and aerosol generation performance of OINDPs, leading to erroneous data and costly testing delays. EnviroMate is a cost-effective, compact, benchtop solution that addresses these issues with considerable value for scientists faced...

 Open the catalog to page 3
EnviroMate™ Copley Brochure-4

EnviroMate™ Performance Data EnviroMate has been specifically designed to accommodate a wide range of inhaler testing apparatus, including: • Next Generation Impactor (NGI) and Glass Twin Impinger (GTI) • Inhaler Testing Workstation™ ITW with DUSA for MDIs and DPIs, Waste Shot Collector WSC2, Andersen Cascade Impactor (ACI) and Multi-Stage Liquid Impinger (MSLI) EnviroMate can also interface with the BRS 200i and NGI Cooler™ for nebuliser testing, and flow controllers and vacuum pumps for testing of other OINDPs. The graph opposite shows the performance envelope of the EnviroMate, with the shaded...

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EnviroMate™ Copley Brochure-5

COPLEY Copley Scientific Limited Colwick Quays Business Park, Road No.2 Nottingham, NG4 2JY United Kingdom

 Open the catalog to page 5

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