Quality assurance at a high level

Transcription

1 OFI Pharma, MEDICAL DEVICES & HygienE Quality assurance at a high level

2 PHARMA Development Authorisation Quality Control Whether medicines are in the development or authorisation stage, or already on the market, we offer you international services based on GMP, EMA and US guidelines and testing of primary, secondary and tertiary packaging materials Fotostudio Pfluegl OFI provides assistance for the targeted, efficient development of your new products. Your concerns will always be given priority. Why? Because, rather than developing our own products, we act as a 100% privately owned, independent and self funded research and testing institute. Development and manufacturing of medicines We specialise in examining chemical, physical and biological aspects in the development and release of medicines. This includes the development and validation of analytical methods, biocompatibility or stability studies as well as tests for identity, content and purity in accordance with Ph.Eur. and USP. In ongoing production we conduct batch controls and incoming goods inspection for you and offer a comprehensive portfolio for investigating damage such as identification of unknown substances and solid particles. We respond quickly to specific cases and tailor the scope of testing to the individual needs of our clients. We are happy to help you devise a testing programme that is appropriate for you. CONTACT Wolfgang Hauffe 1110 Vienna, Brehmstraße 14a t: wolfgang.hauffe@ofi.at OFI

3 OUR SERVICE IS YOUR SUCCESS! Individual Consultancy Flexible Solutions Our services Development of test methods and validation To guarantee that the results of analyses are reliable, test methods need to be fully validated. This ensures that the amount of all substances can be quantified. As a complementary measure we also conduct studies on extractables and leachables. Consultancy services Our experts are always ready to answer your queries and will also work with you to develop solutions for individual problems. In the course of this work, any information is processed thoroughly while maintaining the strictest secrecy. Quality control With our high-quality state-of-the-art equipment for chemical, biological and physical analysis, we provide assistance, from incoming goods inspection to batch release. In addition, we have excellent know-how in the investigation of damage such as in the identification of unknown substances and particles. Stability studies Determination of the shelf life of medicines is a major part of pharmaceutical development and manufacturing. We assist you in the consultancy, planning and implementation stages and provide additional services like photostability testing and computer-controlled data monitoring. Pharmaceutical packaging For the protection of your products we offer physical and chemical testing on packaging, such as container closure integrity testing using the laser headspace method. Cleaning validation We assist you in the development and monitoring of a cleaning concept to identify and eliminate cross-contamination at an early stage. Research and development We develop strategies and plan your projects in cooperation with national and international research partners. We support you in the development of analytical methods and technology as well as in the identification and quantification of new active substances. ag visuell - Fotolia QUALITY IS IMPORTANT TO US Our staff boast the highest knowledge levels in chemical, biological and technical disciplines. Accreditation as testing body in accordance with EN ISO/ IEC Accreditation as inspection body in accordance with EN ISO/ IEC GMP certification Qualified person

4 MEDICAL DEVICES Appraisal of Ideas Development Pre-clinical Testing Patient safety has top priority at all levels. At OFI we examine your medical devices carefully. We carry out tests for biocompatibility and check if your devices also fulfil all other product-specific requirements. What we offer We offer contract research, research as part of funded national and international projects, as well as routine analysis. Biocompatibility Sample preparation and extraction in accordance with DIN EN ISO Chemical characterisation Risk management and literature evaluation in accordance with ISO as well as clinical evaluation based on Meddev In-vitro assessment of cytotoxicity in accordance with DIN ISO and USP <87> In-vitro assessment of irritation/corrosion (OECD Guidelines) In-vitro / In-chemico assessment of sensitisation DPRA-Methode and ARE (OECD Guidelines) In-vivo animal testing in accordance with GLP Product-specific additional requirement Mechanical and physical tests: sealing strength, tear resistance, mechanical stress, leakage, resistance of prints/labels, abrasion resistance, etc. Testing for resistance to chemicals, disinfectants, UV, artificial ageing Migration: testing based on the Austrian Federal Act on Food Safety and Consumer Protection (LMSVG) and EU Regulation (EC) No. 852/2004 sudok1 - Fotolia OFI On request: implementation of in-vivo animal testing in accordance with GLP, jointly with our cooperation partners sudok1 - Fotolia

5 HYGIENE Innovative Concepts for Maximum Safety Hygienic surfaces, materials and medical devices OFI tests your surfaces and materials for their compatibility with disinfectants and for their antimicrobial effectiveness in combating diseases and maintaining good health. Testing for antimicrobial and fungicidal efficacy (e.g. ÖNORM EN ISO 846, ÖNORM EN ISO 20743, JIS Z 2801, ÖNORM EN ISO 22196, ASTM) Resistance to disinfectants (ÖNORM EN ISO ) Determination of resistance to liquids, artificial ageing Detergent effects: with and without impurities (TOC, microbiological methods) Residue analysis and cleaning validation (GC-MS, LC-MS/MS, HPLC-UV/DAD, TOC, microbiological methods, W 319) 91 - Fotolia Hygienic indoor air At OFI we test filter media for biocompatibility, allergen denaturation potential as well as their degree of retention of biogenic hazardous substances such as pollen, mite excrements, spores and bacteria. This can reduce contamination with pathogenic germs and allergens, thus creating low-allergen and low-particle indoor spaces. Determination of the retention efficiency of filter media with regard to airborne allergens and microorganisms (mould, bacteria, pollen, proteins) by means of immunological (ELISA) and microbiological methods Determination of allergen denaturation due to direct effects of filter systems by means of immunological methods Identification of biomarkers by means of sensitive in-vitro assays (cell protein expression), data analysis and interpretation using mass spectrometry and bioinformatics Quantification and identification of particles using a particle counter (2 50 µm) and SEM-EDX ( 0.5 µm) OFI

6 RESEARCH PROJECTS When ideas become a commercial success With its interdisciplinary expertise, OFI as an innovative and strong partner assists you in your research projects. An overview of successfully implemented projects: QUANTUM ( ): development of screening methods for critical trace components of plastics. XENO ( ): development of bioanalytical methods to screen food-contact materials for xenohormones. Biorelation ( ), Ortho.flex.c ( ) and protect ( ): development of in-vitro and in-chemico methods that do not require animal testing to assess the biocompatibility of medical devices. BiKoPla ( ) and E.Lyse ( ): development of antimicrobial surfaces using biocides and physical modes of action. HygO ( ): development of sustainable hygiene concepts and technologies in healthcare institutions to assess the resistance of materials to disinfectants. Pedro Salaverria - Fotolia Airclean ( ) and Aeropore ( ): development of a simulation facility to test filter media, to reduce biological hazardous substances in indoor spaces. YOUR PROGRESS IN GOOD HANDS OFI is a leading expert in MATERIALS TECHNOLOGY and the RENOVATION OF CONSTRUCTIONS. We test and certify the reliability of your materials in automotive engineering as well as in the packaging and construction industries. To make sure that your products are fit for the market. We assess constructions and plan renovation measures, to ensure the safety and sustainable use of houses, bridges, streets and monuments. 120 x EXPERTISE Individual consultancy Trendsetting solutions to complex questions Securing quality and safety OFI Head Office Austria 1030 Vienna, Arsenal, Franz-Grill-Str Vienna, Brehmstr. 14a 2700 Wr. Neustadt, Viktor Kaplan Str. 2 / E 9020 Klagenfurt, Pischeldorfer Str. 28a Sonneberg / Germany t: office@ofi.at Other Companies of OFI: BPV Bautechnische Prüf- und Versuchsanstalt GmbH A-2325 Himberg office@bpv.at