Biomedical Sciences Research Institute

Pharmaceutical Instrumentation and aseptic Manufacture Core Facility Unit

    Pharmaceutical Instrumentation & Aseptic Manufacture

    Academic Coordinator: Dr Bridgeen Callan
    Tel: +44 (0)28 7012 3510
    Email: b.callan@ulster.ac.uk

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    The Pharmaceutical Instrumentation & Aseptic Manufacture Core Facility Unit (PIAMCFU) is located in the University’s SAAD Centre for Pharmacy and Diabetes and offers a range of modern, state-of-the-art instrumentation that would be of use in the preliminary stages of product development and characterization. The Core Facility Unit is well placed to assist small to medium sized enterprises in their initial stages of defining product specification and optimization, in areas related to pharmaceutical, nutraceutical, cosmetic and medical device commercialization.

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    Support and advice can be provided in activities associated with product stability, physical characterization, packaging, drug release and Standard Operating Procedures (SOP) development. These can be performed either in a laboratory setting or adapted to the specific needs and considerations of aseptic manufacture.

    Shimadzu and Waters HP+LC: Enables the separation, quantification and purification of pharmaceutical compounds on both analytical and preparative scales. These fully automated systems have UV (PDA) detectors and fraction collection facilities.

    Varian GC/Headspace: The GC system is fully automated and enables the separation and quantification of volatile pharmaceutical compounds and any residual solvents from manufacture.

    Varian AA 240FS Flame Atomic Absorption Spectrometer:

    Used for trace metal analysis, this instrument can rapidly measure multi elements of interest in each sample using just one aspiration. Up to 10 elements can be analysed at one time.

    Agilent Capillary Electrophoresis: Used for the separation and quantification of both anionic and cationic solutes in a single analysis. This fully automated instrument can also be interfaced to an MS detector for further applications.

    Cary Eclipse Fluorescence Spectrophotometers: Using the latest xenon flash lamp technology, this instrument measures suitable analytes in fluorescence, phosphorescence or chemi/bio luminescence modes. The Biosoftware allows operation of the modes of kinetics, lifetimes, scans, concentrations, simple reads and advanced reads. Using the optic fibre accessory, the instrument can also take measurements of solids and even pharmaceuticals on skin surfaces.

    Cary 50 UV/Vis Spectrophotometers: Again using the latest xenon flash lamp technology, this instrument can measure UV/Vis absorbances of suitable analytes. The Bio-software allows operation of the modes of kinetics, lifetimes, scans, concentrations, simple reads and advanced reads. The samples can also be temperature controlled using the Peltier accessory.

    Perkin Elmer Spectrum RX1 FT-IR: Can be used for characterisation of pharmaceutical analytes. Samples can be solid (KBr discs), liquid (Nujol mull) or gaseous.

    Mettler Toledo V20 Karl Fischer: Measures the water content of pharmaceuticals from 100ppm to 100% by auto-titration.

    GC-MS, LC-MS, ICP-MS and 500 MHz NMR: This range of state-of-the-art analytical instrumentation is listed under the Metabolomics and Proteomics CFU with GC-MS, LC-MS and 500 MHz NMR being of value for advanced formulation and stability studies. ICP-MS is applicable to rapid multi-element trace analysis.

    Erweka EP1 Tablet Press: This is a single punch tablet press and can manufacture tablets and odd shaped products with a diameter of up to 20 mm at a maximum of 4000 per hour. It operates automatically i.e. the tablets are filled, pressed and ejected continuously. The compression force is up to three tons and the filling depth is up to 15mm.

    Buchi B-290 Mini-Spray Dryer with Inert Loop: A quick and easy way to dry pharmaceuticals that are in aqueous / organic solutions or suspensions. It can also be used to dry organic solvents on a laboratory scale.

    Labconco Freezone Freeze Dryers: Compact bench-top lyophilizer that can remove over two litres of water in 24 hours and can hold 4.5 litre of ice before defrosting.

    Erweka AR 402 Wet Granulator: This operates on the oscillating rotor principle by compressing the granules through a sieve of a predetermined size. The motor drive is equipped with a DC motor (500 Watts, max. speed of 3,500 rpm, 60% performance rating).

    Planetary Mills: The Retsch PM200 Ball mill can be used for pulverizing, mixing, homogenizing, colloidal milling and mechanical alloying. It is capable of powerful and quick grinding down to the nano range with two different grinding modes (dry and wet).

    Varian 705 Ds Dissolution Baths: Used to measure dissolution profiles of pharmaceuticals under controlled conditions. Widely used in tablet dissolution studies.

    Digital Copley TBF 1000 Tablet Hardness Testers: Measures the hardness of the tablet using a ’resistance to crushing’ measurement. It has a measuring range of 0 - 520 Newtons. The unit will accept tablets up to 36mm in diameter.

    Viscometer: Brookfield Digital Viscometer with temperature sensor accurately measures the viscosity of a given liquid.

    Malvern Kinexus Oscillating Rheometer: Used to precisely analyze the rheology or flow and deformation properties of materials. Samples can be liquid or solid.

    Malvern Mastersizer 2000: A particle sizeanalyser that measures materials from 0.02µm to 2000µm. This instrument can be used for the particle size measurements of emulsions, suspensions and dry powders.

    Malvern Zetasizer Nano with Autotitrator: This instrument measures:
    - Particle size - of particles and molecules from a maximum size range 0.3 nm to 10 microns using NIBS technology and Dynamic Light Scattering.
    - Zeta potential - in aqueous and nonaqueous solutions.
    - Molecular weight - An absolute measurement using Static Light Scattering and the sensitivity from an avalanche-photodiode detector and fibre detection optics.

    Permegear Diffusion Cells: Used in the study of drug release across a membrane.

    Aseptic Manufacturing Suite The aseptic suite consists of an outer preparation room, an inner preparation room and a clean room facility that currently contains one vertical laminar air flow cabinet. Each area is separated by a changing room. Hand-washing facilities are available in the outer preparation room and in the first changing room. The temperature and pressure are controlled in all areas of the suite and can be adjusted as necessary to provide a facility that can meet specified standards. Remote-controlled cameras are positioned in the clean room, allowing manipulations undertaken in the laminar air flow cabinet to be viewed from the inner and outer preparation areas.