Simec AG - Easyfairs

Transcription

Simec AG - Easyfairs
SIMEC AG
Company Profile
SIMEC AG is an independent analytical laboratory (privately owned corporation),
experienced for 25 years. For almost every analytical request SIMEC AG is able
to offer a solution.
SIMEC AG's target is to provide you with comprehensive support and advice
before, during and after your order.
Analytical services
• Pharmaceutical analyses under GMP acc. to PhEur and USP
• Food analyses
• Microbiological analyses (GMP, ISO, client specific, own developed)
• Enviromental analyses
• Specialities e.g. THC, steroids, narcotics
Other Services
• Conformity testing in the field of food contact/migration e.g. regulation (EC) No.10/2011
• Stability testing according to ICH-guidelines: testing periods of one month up to several years
• Validations and method transfer
• Consultancy and support
• Hygiene inspections
• Organic syntheses
Quality
The quality of our work is permanently controlled by proficiency testing as well as by audits of customers and
authorities.
• GMP certification by Swissmedic (Swiss surveillance authority for medicines)
• ISO/EN 17025 accreditation by SAS (Swiss Accreditation Service; STS 0443)
• Successfully audited by FDA (Food and Drug Administration)
Methods
Nearly all methods can be performed according to GMP; validations and method transfers are
individually offered on request.
• GC FID-detection, direct injection, cool-on-column- and Headspace-technology, chiral methods, packed
columns
• HPLC DAD-, UV-VIS-, Fluorescence- and Refractive Index (RI)-detection; column temperatures up to 90°C,
chiral methods, post-column derivatisation
• IR direct measurement of liquids and solids via KBr-pill/window or by modern ATR-technology
• methods according to PhEur and USP, e.g.: full analyses of complete monographs, assays by GC/HPLC/
titration,... impurities, migration studies (testing of containers and labels), TLC, limit tests, microbiological
detection and enumeration tests, microbiological assays of antibiotics, microbiological challenge tests,
endotoxines, Nitrogen/Protein content by Kjeldahl, capillary viscosity (Ubbelohde), rotational viscosity
(Brookfield), disintegration time, dissolution studies, hardness of pills, drop point, freezing point, different
melting point methods, heavy metals (PhEur 2.4.8 /USP <231>), chromatographic profiles, color and turbidity,
spreadability, water by Karl-Fischer, loss on drying, residual solvents, composition of fatty acids, sieving
analyses, osmolality... and many more.
• ICP-SFMS high resolution elemental analyses performed at our partner lab ALS: elemental impurities acc.
PhEur 2.4.20, <USP 232> and ICH Q3D, ultra-trace elemental analyses in a wide range of matrices,
screenings covering up to 70 elements
Infrastructure
On more than 850 m2 of laboratory area we have installed
• GC systems (Agilent 6890 and 7890B) with FID-detection, direct injection, cool-on-column injection,
headspace injection, capillary and packed column support
• HPLC systems (Merck-Hitachi) with DAD-, UV-VIS-, Fluorescence- and RI-detection
• State-of-the-art equipped microbiological laboratory
• IR-spectrometer (Thermo-Nicolet), with ATR-unit and digital library
• UV-VIS-spectrometer (Shimadzu)
• Coulometer (Metrohm) for trace determination of water
• Titration systems (Metrohm)
• TLC-systems (Linomat/Camag)
• climatic cabinets according to all ICH-requirements, including modern electronic logging and alarming
system
• a multitude of smaller analytical devices for nearly every purpose (e.g. disintegration and dissolution testing,
pill hardness, osmolality, melting point, optical rotation, refractive index, germ counting, …)
• via partner labs: ICP-SFMS (high resolution ICP-MS), LC-MS/MS, GC-MS, SPME-GC-MS, LC-Q-ToF-MS,
NMR, …
Partners
Simec AG is part of a strong network of specialists dedicated to analytical questions, e.g. isolation and structure
determination of impurities, solid state analysis, NMR, ultra-trace elemental analyses. Thanks to our partners, we
are able to provide our customers solutions even for very special or demanding problems. In addition, most of
them work according to GMP, too.
Customers
Simec AG has a wide range of national and international customers, including global market leading companies
as well as medium and small companies.
Please ask for references.
Our Strength
• High quality paired with flexibility.
• Orientation on the customer.
• Fair pricing.
If you have any demand, you are welcome to contact us.
SIMEC AG
Postfach 413
CH-4800 Zofingen
www.simec.ch
[email protected]
Tel:
+41 (0)62 752 83 08
Fax: +41 (0)62 752 83 09
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