Mechanical modifications to the outside of the port w/o compromising pharmacopoeial requirements. To, e.g., facilitate assembly of MP adapters and introduce P1 tap.
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Fully inspected and comes with a certificate.
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For nasal administration, expansion chamber as recommended by the FDA for the estimation of the deposition in the respiratory tract. The configuration consists of an expansion chamber (in which the nasal aerosol is generated) assembled to an impactor (e.g. an ACI, NGI, etc.). Three different sizes: 1 L for powder aerosols, 2 L and 5 L for liquid sprays. Comes with a clamp and adapter between glass and NGI. Optionally with a stand for the 5 L chamber. Adapters available for the insertion of the device.
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Nasal Spray Actuator
Take the worries out of Nasal Spray testing with FIA’s configurable NASAL SPRAY ACTUATOR. This actuation system enables the user to define multiple actuation methods. The nasal actuator measures the stroke travel distance and the force constantly, most notably end force at actuation. The velocity can be calculated from the distance and the time, recorded by the software.
The nasal actuator control box can be used to set number of actuations for dosing, rest time between each actuation, number of waste dose etc. The equipment can be easily adapted to most device geometries. The compact and open design makes it perfect to integrate with dose collection on filter, and with optical techniques for determination of, e.g., spray pattern, plume geometry (laser pulsed camera) and droplet size (laser diffraction). We can guide you to the best possible solution based on our historic implementations.
Main benefits:
- Control pivotal parameters affecting the dose and the spray
- Release technical staff from routine functions and potential ergonomic strain
- Elucidate and record actuations in documented fashion
The regulatory guidelines which are applicable:
- US (FDA) – Guidance for Industry: Bioavailability and Bioequivalence for Nasal Aerosols and Nasal Sprays for Local Action, Draft 2003.
- US (FDA) – Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products CMC Guidance, Draft 2002.
- EU (EMEA) – Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, EMEA 2006.
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Net 1000 pcs, extras.
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Fully inspected and comes with a certificate.
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Fully inspected and comes with a certificate.
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Fully transparent of acrylic glass, fits 6 trays. Economic in space and practical when coating plates. Stable enough to be put onto a shaker table with trays filled with solvent to aid work-up.
Material: Poly carbonate. -
New, plenty in stock.
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Fully inspected and comes with a certificate.
