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Analytical services

Sanfarm sp. z o.o. pharmaceutical manufacturer is a modern factory, having at its disposal not only a state-of-the-art production facilities but also a very well equipped quality control laboratories, allowing us to offer our clients a variety of analytical services.

 

First and foremost we offer:

  • a very wide range of physico-chemical analyses, covering both classical analyses and instrumental analyses, including, among others:
    • Determination of chemical elements content with the use of AAS method
    • HPLC, GC, TLC chromatographic analyses
    • UV-Vis, IR, NIR spectroscopy analyses
  • microbiological analyses of purified water
  • microbiological examinations of the manufacturing environment: the volumetric method of air analysis, surface and personnel examination with the use of contact plates
  • output material's identity confirmation with the use of NIR analysis, allowing fulfilment of cGMP requirements in the scope of output material's identity confirmation in every single package. It may also lead to savings and optimization of analytical processes, by avoidance of different laborious and time-consuming identity tests for a large number of samples.
  • analyses of output materials, direct packing materials, medicinal products and intermediate products
  • microbiological analyses of output materials, direct packing materials, medicinal products and intermediate products
  • determination of: ingredients content, the amount of liberated active ingredient, liberation profile and contaminants.
  • validation of analytical and microbiological methods
  • carrying out seasonal medicinal products' analyses in stability chambers, in line with the stability study programme
  • steam sterilization (autoclave)
  • short periods of analyses execution
  • qualified and experienced personnel, working in line with quality standards and a quality assurance system compliant with cGMP requirements
  • certification procedure by QP, for contracted and executed analyses and their results

  • high-class analytical equipment, being under a constant supervision:
    • Varian AA280FS atomic absorption spectrometer AAS, UV-Vis Varian CARY 100 BIO spectrometer, UV-Vis Varian CARY 100 Conc spectrometer, IR Varian 1000 FT-IR Scimitar Series spectrometer, Thermo Nicolet NIR ANTARIS II spectrometer,
    • HPLC Waters 2695 and e2695 chronomatographs with UV-Vis 2487 and 2489 detectors, HPLC Waters 2695 chronomatograph with 2996 photodiode detector, Varian CP-3800 gas chronomatograph with FID detector and HeadSpace autosampler TELEDYNE TEKMAR HT3TM,
    • TLC analysis set, composed of the DESAGA Digital-Documentation-System DD 50 incl. ProViDoc®
    • AP-100 ATAGO polarimeter, FP 90 Central Processor METTLER TOLEDO used to determine melting and boiling speed
    • DR40 Combined Meter METTLER TOLEDO used to determine density and refraction, including a sample feeder.
    • Varian VK 7025 automatic systems, measuring liberation speed,
    • T50 and DL50 METTLER TOLEDO titrators,
    • Fusion TELEDYNE TEKMAR TOC analysis apparatus,
    • LV DV-III BROOKFIELD LABO PLUS digital heometer,
    • DL 38 METTLER TOLEDO, to measure water content in solid and liquid samples with the Karl Fisher method,
    • Kiejdahl B-324 Distillation Unit BÜSCHI set
    • SCHOTT AVS470 capillary viscometer

Should you find our initial offer interesting, we would be more than happy to provide you with any additional information and respond to your request for quotation.