At LOUNGES CLEANROOM PROCESSES, BioChem Labor für biologische und chemische Analytik GmbH will also present its "Concept for Microbiological Hygiene Monitoring" at its stand D4.4. With this, BioChem supports manufacturing companies in their controlled production process. This includes, for example:
- Consulting on the creation of a hygiene concept for cleanrooms regarding clothing, cleaning, monitoring, personnel monitoring, process simulation/media fill
- Consulting on cleanroom qualification
- Preparation of qualification documents: IQ | OQ | PQ as well as risk analyses to determine monitoring points
- Practical implementation of microbiological qualification including incubation, evaluation and report
- Incubation and evaluation of samples from routine hygiene monitoring
- Identification of bacteria, yeasts and fungi: morphologically/microscopically, by mass spectrometry (MALDI TOF) or by molecular biological methods (PCR)
- Microbial environmental monitoring in manufacturing plants (air sampling and surface swab samples in cleanrooms on site)
- Further consulting and laboratory services in the context of microbiological hygiene monitoring on request, e.g. effectiveness testing of disinfectants
As a GMP-certified quality control laboratory, BioChem offers a wide range of consulting and laboratory services for the qualification and operation of cleanrooms. All consulting and documentation is precisely adapted to the conditions on site and individually tailored to customer's needs. BioChem supports manufacturers in their goal of ensuring the highest product and patient safety.
The BioChem experts always consult customers individually on their current project or concern. During a visit to the exhibition stand D4.4, further details can be discussed with the experts directly on site.
