Microbiological testing of non-sterile pharmaceutical products
In the microbiological analysis of non-sterile products, our experts proceed in accordance with national and international pharmacopoeias and also with current DIN EN ISO procedures.
In addition, we check all procedures for suitability and their validation.
Our range of services:
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
Pharmaceutical Testing Laboratory in WESSLING Hungary Ltd. performs quality control testing of pharmaceutical raw materials (APIs) and finished products.