Eszközök és módszerek

Intro

Eszközök és módszerek

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At WESSLING, the thrust of our analysis and consulting for pharmaceuticals and medical products along with our service portfolio is international. This can be observed firstly in the close cooperation between our experts at the Budapest and Münster sites.  WESSLING is therefore also a partner to pharmaceutical manufactures whose markets lie outside of Europe:

 
  • Both laboratories in Münster and Budapest work according to GMP standards
  • Both pharmaceutical sites hold a manufacturing permit according to Section 13 of the German Pharmaceuticals Act (AMG) and an EU import permit
  • Our pharmaceutical laboratory in Münster is inspected by the FDA (Food and Drug Administration). As a result, we are also an analysis partner to customers who are operating in the US market
  • The close cooperation between our two sites means combined capacities and know-how for our customers, resulting in on-time processing - even of larger orders or those for express analysis

One-stop shop: from us, manufacturers of pharmaceuticals and medical products obtain all laboratory analyses from a single source: microbiology, chemistry and consulting. Thanks to the close integration of our laboratory analysis and consulting, WESSLING is your full-service provider:

Analysis:

  • Testing of all dosage forms: testing of sterile and non-sterile solid, semi-solid and liquid pharmaceuticals
  • Testing of cytostatic drugs and permit for handling narcotic drugs according to Section 3 of the German Narcotic Drugs Act (BtMG)
  • Sterility tests using two isolators: redundancy minimises the risk of failure and thus guarantees that your orders are processed on time
  • Determination of elementary contamination by means of ICP-MS/OES

Special analysis:

  • Wealth of experience and know-how in developing and validating analytical methods (HPLC, dissolution, GC)
  • Approval analyses with subsequent market release by experienced WESSLING QPs (Qualified Person) and logistics solutions
  • Close integration of analysis and consulting

70 experts in Budapest and Münster work with the latest technical equipment in equally cutting-edge, generously sized facilities; our laboratory in Münster covers a total floor space of around 1000 square metres

Our pharmaceutical analysis equipment:

  • Approximately 20 HPLCs with UV/VIS, DAD, fluorescence, RI or MS detector
  • 2 uHPLCs
  • 3 gas chromatographs with head space and trap unit, FID or MS detector
  • 3 ICP-MS and 1 ICP-OES
  • 10 dissolution testers (UV on-/off-line), paddle and basket
  • 2 disintegrators
  • FT-IR spectometry with ATR unit
  • UV/VIS spectometry
  • Polarimetry
  • Density measuring unit
  • Automatic titration unit
  • TOC
  • Particle size distribution (Malvern)
  • 2 endotoxin readers: fluorescence and recombinant measurement
  • 2 sterile test isolators with fast-action sluices