UNIVERSITY OF PARMA INTERDEPARTMENTAL CENTRE FOR INNOVATION IN HEALTH PRODUCTS, BIOPHARMANET-TEC

Transcription

1 UNIVERSITY OF PARMA INTERDEPARTMENTAL CENTRE FOR INNOVATION IN HEALTH PRODUCTS, BIOPHARMANET-TEC RULES FOR THE USE OF THE CENTER EQUIPMENTS ACQUIRED WITHIN THE AGREEMENT BETWEEN THE UNIVERSITY OF PARMA AND THE EMILIA-ROMAGNA REGION CONCERNING THE POR FESR ACTIVITY I.1.1 CREATION OF TECNOPOLI Article 1 - Introduction The present document is drawn up based on the Article 2- point f of the agreement between the University of Parma and the Emilia Romagna region concerning the POR FESR activity I.1.1 of the creation of Tecnopoli and in particular it refers to the use of equipment of the Interdepartmental Centre for Innovation in Heath Products, Biophatrmanet-TEC acquired by the Centre or conferred to the Centre by the Departments according to the agreement. Article 2 - Purpose The present Regulation governs the organizational and economic aspects related to the use of equipment referred to Article 1 by external users from the Interdepartmental Research Centre Biopharmanet-Tec in particular from other Centres and Laboratories of the High Technology Network and enterprises of the Emilia Romagna region with the aim of maximizing the use and sharing of equipment resources acquired under the Tecnopolo. Article 3 Application fields The dispositions of this Regulation shall apply to equipment, whether they consist of single instruments or set of experimental devices, listed in Annex 1. These equipment are primarily but not exclusively, constituted by instruments acquired or conferred under the agreement referred to in Article 1 of this Regulation. Article 4 - Access and use of equipment The Centre provides a minimum of 5 working days per month for the use of equipment by users of the Centres and Laboratories of the High Technology Network and also of Emilia Romagna region. The use of equipment by external users is guaranteed by Centre staff who has the necessary skills and qualifications. Equipments are available for users referred in Article 2 of this Regulation by two modalities: 1) specifically regulated research contracts; 2) paid performance. The type of measurements and analysis that can be realized with the equipment by paid services is listed in Annex 2. It is provided together with the cost for each type of measurements or analysis. The request for use of equipment must be submitted via to biopharmanet-tec@unipr.it. External users will be able to witness the measures or tests execution upon prior authorization by the Centre Director which may be granted only after: 1) explicit acceptance of the behavioural code for visitors (internal document of the Centre); 2) subscription of a specific insurance against accidents and civil liability by external users. Article 5 - Publicity The current Regulation is published on the University of Parma website at Article 6 - Regulation Changes Any proposals for amending or supplementing of this Regulation must be approved by the Council of the Centre.

2 Any modification or variation of this Regulation and Annex, approved by the Council of the Centre, must be communicated by the Director to the competent academic authorities and will be approved by special decree of the Rector.

3 Annex 1 List of Equipment Equipment Description Functionality Equipment Location Agreement High speed granulator Small-scale production of powders or granules blends to use as well as they are or for the production of tablets, capsules, inhalation powders Friabilometer Tablet friability measurement Disintegration time apparatus Measurement of disintegration time of tablets and capsules Fast HPLC, Identification and quantification of organic molecules Dissolution test apparatus Pan coater UPLC-MS, Biological hood for the manipulation of biological or sterile samples + inverted microscope for the observation of cell cultures + CO 2 incubator Cabinet PP +24 cages Ultracentrifuge Fluorimeter Freezer -80 C Determination of the dissolution rate or drugs released from solid dosage forms Coating of pharmaceutical solid forms (tablets, capsules, granules, pellets) with polymeric or lipid films Ultra performance liquid Chromatograph associated with a triple quadrupole mass detector for the screening of molecules of interest in organic synthesis Realization of cell cultures Stable in strictly controlled conditions of experimental immunosuppressed animals Efficient separation of biological samples, microand nanosuspensions Quantification of the fluorescence degree of biological samples, cells, and organic solutions Cryopreservation of samples and cells Pharmacology, Parco Area delle Scienze, Parma Pharmacology, Parco

4 Freezer -80 C Lyophilization Next generation Impactor, Andersen Cascade Impactor, Pompe Erweka, Copley aspirator Miniglatt, fluid bed-granulator Mini Spray Dryer Buchi Thermal analysis apparatus DSC + TGA Mettler Toledo Cryopreservation of samples and cells Production of solid pharmaceutical forms intended for parenteral administration, polymeric sterile scaffolds, and the preservation of biological samples. Aerodynamic assessment of products for lung administration. Pilot scale production of granules to be used as such or for the production of capsules, inhalation powders and for drying granules or pellets Small-scale production of microparticles Characterisation of the solidstate (polymorphism, amourphous, crystallinity) of organic samples Pharmacology, Parco Area delle Scienze, Parma K.-F. Mettler Toledo Tritation Water content determination UV-Vis spectrophotometer with flow cells Microcentrifuge, Refrigerated Microcentrifuge, microplate reader, Cryosystem, Horizontal Bath Powder X-ray benchtop Rigaku diffractometer Malvern Mastersizer diffractometer Roto Junior Zanchetta (High Shear Mixer) Determination of the drug amount that passes from a solid pharmaceutical form to the solution during a dissolution process. Isolation, preservation and quantification of cell cultures. Determination of the degree of crystallinity of a material in powder form Determination of the volume diameters and size distribution of a powder or a suspension Production on a pilot scale of powders or granules to be used as such or for the production of tablets, capsules, inhalation powders Lab. Biopharmanet-TC pharmacology, Parco Area delle Scienze, Parma

5 Liquid chromatograph single quadrupole LC-MS Determination and quantification of various compounds in complex mixtures * Equipment to be acquired by

6 Annex 2 Prices of paid performances (Prices in Euro, net without VAT) Development of a quali-quantitative analytical method for drugs of pharmaceutical, cosmetic, dietary and food compound Development of a method for recognizing and determining a possible contaminant or impurity of a substance (synthesis intermediates, degradation products etc.) in the pharmaceutical, cosmetic, dietetic and food field Development of a method of analysis for the recognition and the dosage of an active substance in a pharmaceutical, cosmetic, dietary and food preparation with existing references in the literature Particle size analysis by laser diffractometry Disaggregation time test according to the method of Pharmacopoeia Friability test of tablets according to the method of Pharmacopoeia Dissolution test of a drug according to methods of Pharmacopoeia (UV-vis analytical method) Dissolution test of a drug according to methods of Pharmacopoeia (known HPLC analytical method) In vitro cytotoxic activity study of a drug or of a pharmaceutical product Repeated application of quantitative determinations of a component in a mixture, when the method is known: each determination Repeated application of quantitative determinations of two components in a mixture, when the method is known: each determination Repeated application of quantitative determinations of a component in a mixture with two different methods Thermal Analysis (DSC) of material of pharmaceutical interest X-ray diffraction analysis (RX) on powder Size distribution determination of an aerosol by impactor according to the method of Pharmacopoeia; up to 5 tests, each one 1, Size distribution determination of an aerosol by impactor according to the method of Pharmacopoeia; more then 5 tests, each one 1, Aerosol form characterization (Plume geometry, spray-pattern) Size distribution of an aerosol by Laser Diffraction, up to 9 tests, each one Size distribution of an aerosol by Laser Diffraction; from 10 to 19 tests, each one Size distribution of an aerosol by Laser Diffraction; from 20 to 49 tests, each one

7 Size distribution of an aerosol by Laser Diffraction; over 49 tests, each one Evaluation of the cholesterol efflux potential of sera; semi-selective determination, each one Selective determination, each one