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Pharmaceutical testing

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All current pharma testing are provided in high-tech production driven labs with a highly skilled team; the approved and calibrated equipments are applied. Inspected facilities - internal and external audits from pharma clients (6 per year)

The laboratory offers a broad range analyses according to the principles of Good Laboratory Practice:

  • Stability studies (ICH Q1A (R2), stress testing of pharmaceuticals and acive substances (photostability, hydrolysis, oxidation)
  • chemical analyses of pharma products
  • content of impurities and related substances in pharmaceuticals products (studies)
  • microbiological testing
  • method development  and validation studies
  • optimizing and re-validation test methods
  • testing for cleanliness and batch to batch stability analysis

The services compromise products:

  • pharma  water  analyses
  • material sterility, efficiency of antimicrobial preservation
  • human and veterinary drugs, food supplements, cosmetics, etc.,
  • controled substances

Eurofins pharma testing labs are accredited:

  • Decision of State Institute for Drug Control  for Bratislava Testing Laboratory  from 01.10.2009, No. Š-01/08; authorisation body for pharmaceutical testing Aqua purificata and pharmaceutical products for human use and glass containers
     
  • Certificate of GMP Compliance of a Manufacturer accreditation for Non Clinical Evaluation of the safety active substances in pharmaceutical products for human and veterinary use in compliance with GLP and company has established as authorisation body for pharmaceutical product testing, Decision of State Institute for Drug Control for Piešťany and Bratislava Testing  labs; from  5.10.2012, Certificate  No.:SK/021V/2013
     
  • Decision of State Institute for Drug Control  for Piešťany Testing Laboratory from  29.01.2009, č.Š-06/09,pharmaceutical  testing: microbial analyses of  drugs  and pharma  water  analyses, water for injection, sterility, efficiency of antimicrobial preservation and microbial acceptable cleaned water and containers
     
  • The company is accredited according  SLOVAK NATIONAL ACCREDITATION SERVICE: Osvedčenie o akreditácii SNAS č. S-106, from 18.11.2008, v znení Dodatku č. 1/09 zo dňa 17.04.2009
     
  • The company is accredited according  Czech Accreditation  Institute, Osvědčení o akreditaci (ČIA)  č. 110/2009 pro zkušební laboratoř č. 1276, from  25.02.2009

WIDE VARIETY OF EQUIPMENT: e.g.

GAS CHROMATOGRAPHY

  • detectors FID, TCD, ECD and MS ( fy Agilent Technologies)
  • head-space sampler (fy Agilent Technologies)

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY  

  • UV/VIS Detectors ( fy Varian),
  • Diode Array Detector, Fluorescence Detector, Refractive   Index Detector   (fy Agilent Technologies)

3200 Q TRAP® LC/MS/MS System (fy Applied Biosystems)
UV-VIS SPEKTROPHOTOMETER
IR SPEKTROMETER (fy Nicolet)
AUTOMATIC TITRATORS (fy Metrohm)
POLARIZING MICROSCOPE-Nikon Eclipse LV 100POL
Fluorescence Microscope -Olympus BX 41
ICP Emission Spectrometer Liberty 220, ICP-OES
Atomic Absorption Spectrometer Spectr AA-220FS, AS-20
Mercury Analyzer AMA-254
TOC ANALYSER (fy Teledyne Tekmar)
FLASH POINT ANALYSERS (fy Petrotest)
AUTOMATIC DISTILLATOR (fy Petrotest)
VISCOMETERS - determines dynamic and kinematic viscosity (fy Anton Paar)
DISSOLUTION (fy Distek®)
DISINTEGRATION TESTERS (fy Varian)
HARDNESS AND FRIABILITY TESTERS (fy Sotax)
CONDUCTOMETER (fy Orion)
pH METER (fy Metrohm)
OSMOMETER (fy Knauer)
IR MOISTURE ANALYSER ( fy Sartorius)
Skin penetration tests
DVS/AQUADYNE dynamic vapor sorption,