Mikrobiológiai vizsgálatok nem steril termékeknél

Intro

Pharmaceutical analysis of non-sterile products

Mikrobiológiai vizsgálatok nem steril termékeknél

[Translate to Magyar:]

Determination of bacterial count (bioburden) according to Ph. Eur. 2.6.12

  • Total aerobic microbial count (TAMC)
  • Total combined yeasts/mould count (TYMC)

Detection of specified microorganisms according to Ph. Eur. 2.6.13

  • Quantitative and qualitative detection

Testing for adequate preservation (KBT) according to Ph. Eur. 5.1.3

Combined tests for ready-to-use pharmaceuticals according to Ph. Eur. 5.1.4

Combined tests of herbal medicinal products for oral use according to Ph. Eur. 5.1.8 according to categories A, B, C

Microbiological hygiene monitoring and particle monitoring

  • Sampling by qualified WESSLING employees on request
  • Provision of contact plates, air sampler and particle measuring device
  • Evaluation of contact plates: aerobic bacterial count, yeasts / moulds, enterobacteriaceae
  • Surface inspection by means of swabs
  • Airborne germ measurements: germ count and moulds
  • Particle measurements

Microbiological determination of the value of antimicrobial agents (e.g. neomycin, gentamycin)

Identification of germs

  • Biochemical identification of germs using API
  • Using Maldi-TOF/MS
  • Creation of house germ databases

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