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Copley-Inhaler-Testing-Brochure - 1

Driving Results in Inhaler Testing METERED-DOSE INHALERS • DRY POWDER INHALERS NEBULISERS • NASAL SPRAYS 2020 EDITIO

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Inhaler Testing About Us Copley: Driving Results for Over 70 Years Founded in 1946 in Nottingham, UK, Copley remains family owned and managed. We are recognised as the world’s leading manufacturer of inhaler test equipment, in addition to being a trusted provider of test instrumentation for other pharmaceutical dosage forms. We continue to work closely with industry groups and leading experts to bring relevant new products to market, with all equipment backed by expert training and lifetime support. These commitments are exemplified by our investment in the ISO 9001:2015 Quality Management...

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The Copley Promise Innovative Innovative product design features ensure ease-of-use and maximum productivity by streamlining work flows. Compliant Products are certified to quality standards defined by global pharmacopoeias and regulators, ensuring data integrity. Trusted Robust design and manufacture from a company with over 70 years’ experience guarantees product reliability and longevity.

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Inhaler Testing Device Safety, Quality and Modified Configurations for use at 60 and 90 L/min ISO 9001:2015 Quality Management System International Standards Organisation (ISO) Expert Groups Next Generation Impactor (NGI) Current Pharmacopoeial Specifications 19 Delivered Dose Aerodynamic Particle Size Distribution (APSD) Multi-Stage Liquid Impinger (MSLI) European Pharmacopoeia (Ph.Eur.) Glass Twin Impinger (GTI) Impactors for testing: MDIs with Spacers and VHCs Nasal Delivery Systems Abbreviated Impactor Measurement (AIM) Table of Contents Equipment Selection Guide Inhaled Drug Products...

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Flow Meters Analytical Errors Instrument-Related Errors Flow Meter Model DFM4 Flow Meter Model DFM 2000 Labour Saving Tools - Delivered Dose Uniformity Pharmacopoeial Criteria Mouthpiece Adapters DUSA Shaker Stage Mensuration Vacuum Pumps Labour Saving Tools - Cup Coating (NGI) High Capacity Pump HCP5 Restoring Performance Super Capacity Pump SCP5 Labour Saving Tools - Sample Preparation (ACI & NGI) Gentle Rocker Qualification Documentation IQ/OQ Documentation Data Analysis Software CITDAS Sample Preparation Unit SPU 2000 Spare Tubing Labour Saving Tools - Impactor Cleaning (ACI & NGI)...

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Equipment Selection Guide Equipment Selection Guide Metered-Dose Inhaler (MDI)* Nasal Spray (Aqueous) DUSA for DPIs (Page 28) Filter Holder & Adapter (Page 32) N/A (Direct into Vial/Flask) Mouthpiece Adapter (Page 90) Mouthpiece Adapter (Page 90) Mouthpiece Adapter (Page 90) Vacuum Pump (Page 91) Vacuum Pump (Page 91) Breathing Simulator (Page 75) Flow Meter (Page 88) Critical Flow Controller (Page 80) Waste Shot Collector (Page 31) Flow Meter (Page 88) Breath Actuation Controller (Page 86) - Option Waste Shot Collector (Page 31) Cascade Impactor: Cascade Impactor: Delivered Dose Uniformity...

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Inhaled Drug Products Inhaled Drug Products Introduction The devices used for inhaled and nasal drug delivery are collectively referred to as orally inhaled and nasal drug products (OINDPs). The range of products available is broad, encompassing inhalers (metered-dose, dry powder and aqueous droplet), nebulisers (jet, ultrasonic and vibrating mesh) and nasal sprays (aqueous based, dry powder and propellant based). larger particles, for example lactose, to which it attaches. During aerosolisation the active is stripped from the carrier and inhaled whilst the carrier particles impact on the...

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Inhaler Testing Drug Delivery Devices MDI incorporating Dose Counter MDI with Valved Holding Chamber (VHC) APPLICATIONS Inhaled drug products are becoming increasingly popular as a means of delivering local or systemic therapy via the lungs or nasal mucosa. Inhalation therapy has been in use for a number of years: a) Locally (directly) to treat lung diseases such as asthma and chronic obstructive pulmonary disease (COPD), and to deliver locally acting drugs such as antibiotics and antivirals directly to the lungs to curb infection, and b) Systemically (absorption), for example in pain...

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Inhaled Drug Products 2. Dry Powder Inhalers (DPIs) Historically, the DPI was limited to single dose capsule systems and the inhaler market was dominated by the chlorofluorocarbon (CFC) propelled MDI. When, in 1997, the Montreal Protocol effectively banned the ozone depleting CFCs, the pharmaceutical industry was faced with the option of: a) Finding an alternative propellant (as in the HFA propelled MDI), or b) Developing new ways of delivering drug to the lungs It is the latter that provided a resurgence of interest in the DPI. As the name suggests, in the DPI the medication comes in the...

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Inhaler Testing Drug Delivery Devices Ultrasonic Nebuliser 4. Nebulisers A nebuliser may be defined as a device that can convert a liquid into aerosol droplets to produce a respirable cloud suitable for inhalation. Normally it must be loaded with the drug before each treatment. Once activated it operates on a continuous basis. It should not be confused with the Aqueous Droplet Inhaler described in the preceding section which delivers a pre-metered dose or bolus of medication. This difference is important since the regulatory bodies traditionally classified nebulisers as medical equipment....

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Inhaled Drug Products Drug Delivery Devices Powder-based Nasal Device Metered Nasal Spray Pump 5. Nasal Delivery Systems a) Metered Spray Pumps (Aqueous-based) Traditionally, nasal preparations have been used for the local administration of antihistamines, decongestants and steroids in order to alleviate cold or allergy symptoms and nasal congestion. Mechanical metered-dose spray pumps have largely replaced droppers and squeeze bottles as the drug delivery device of choice because of the latter’s inability to deliver an accurate and consistent dose. More recently attention has focused on...

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Inhaler Testing Organisations and their Roles Introduction 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. In Europe and in the USA this function is performed by the European Medicines Agency (EMA) and by the Food and Drug Administration (FDA) respectively. The regulatory authorities are supported in this role by: a) The Pharmacopoeias whose job is to define the standards with which the drug formulation shall comply and the methods by which compliance...

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