Ancillaries

Copley offers a range of ancillary products required in addition to the Dosage Unit Sampling Apparatus (DUSA) and Cascade impactor to make up fully operational systems for determining the Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) of orally inhaled and nasal drug products (OINDPs).

Ancillaries for Inhaler Testing

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Breathing Simulators
Breathing Simulators
Representative breathing patterns should be employed during inhaler testing that characterise the age and condition of the patients to be treated (paediatric to geriatric, mild to severe impairment of the lungs).
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Flow Controllers
Flow Controllers
Copley’s Critical Flow Control TPK range and Breath Actuation Control BAC range are designed based on the requirements set out by both the European and the United States Pharmacopoeia for testing MDIs, DPIs, Nebulisers, ADIs and Nasal Products.
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Flow Meters
Flow Meters
Both DDU and APSD data can be severely compromised if the inlet flow rate (the flow rate at the entrance to the induction port or DUSA) used during testing is inaccurate and/ or inconsistent, generating discrepancies with regard to its effects on both the cascade impactor itself and the inhaler under test.
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Vacuum Pumps
Vacuum Pumps
At the heart of every inhaler testing system is the Pump. The Pharmacopoeias are careful to point out that “a vacuum pump with excess capacity must be selected in order to draw air at the designated volumetric flow rate” through the system and in the case of Dry Powder Inhalers, to generate sonic flow. Copley offers a choice of three pumps dependent on the set-up concerned and the capacity required.
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NGI Cooler
NGI Cooler

Exacerbated evaporation caused by the thermal mass of the NGI may be an issue for devices such as nebulisers that deliver the drug as an aerolised solution. Loss of solvent reduces droplet size, producing artificially low particle size measurements and compromises the integrity of APSD data.

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Inhaler Testing Workstation (ITW)
Inhaler Testing Workstation (ITW)

The hub of an inhaler testing system, the ITW is a modular workstation designed to aid handling and manipulation of the various pieces of test apparatus and accessories, improving workflow. The ITW offers analysts the flexibility to pick and choose the attachments necessary for their test set-up needs. Simply connect the required attachments and start testing with greater ease.

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Glass Expansion Chambers
Glass Expansion Chambers

The majority of nasal products are designed to generate droplets/particles with a mass median aerodynamic diameter (MMAD) of greater than 10 to 20 microns. This is to increase nasal deposition and minimise deposition in the lungs. However, most sprays deliver a proportion (typically <5%) of fine droplets in the <10 micron range. It is important to quantify this Fine Particle Dose (FPD) since it can penetrate beyond the nasal tract and into the lower respiratory tract or lungs, which may be undesirable. Cascade impactors are designed to capture particles in the range 0 to 10 microns and are widely used for this application.

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Mouthpiece & Nosepiece Adapters
Mouthpiece & Nosepiece Adapters

Ensure a proper seal is maintained between the device under test and the sampling apparatus with our range of Mouthpiece and Nosepiece Adapters. Specially moulded from high quality silicone rubber to ensure superior performance, adapters are available for the more common devices on the market, or can be custom-made for your specific device type.

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