Microbiological environmental monitoring

Microbiological environmental monitoring

Details

  • Start date: 29 November 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 30 November 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 2 days, 8 academic hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    250 Euro + 50 Euro for each next participant

     

    Target audience: managers and employees of pharmaceutical microbiological laboratories, quality control departments.

     

    In a programme:

    1. Regulatory framework.

     • A series of international standards ISO 14644, ISO 14698 – Cleanrooms and related controlled environments. Biocontamination control.

    2. General principles of microbiological monitoring.

     • Goals and objectives of microbiological monitoring, objects of control.

     • Documented biocontamination control program.

     • Requirements for acceptable levels of microbiological purity – target level, warning level, action level.

     • General principles of sampling and transportation of samples, choice of nutrient media and incubation conditions, interpretation of the results.

    3. Microbiological monitoring of the air environment.

     • Aspiration and sedimentation control methods – principles of methods, advantages and disadvantages.

     • Review of equipment for microbiological control of the air environment, principles of sampling, advantages and disadvantages of various types of equipment, approaches to equipment selection.

     • Testing, recommended levels of microbiological purity, frequency of sampling, validation activities.

    4. Microbiological monitoring of surfaces.

     • Classical control methods – sampling techniques, possibilities, advantages and disadvantages of methods.

     • Alternative methods of control – an overview of the available methods and equipment for their implementation, the advantages and disadvantages of alternative methods.

     • Surface cleanliness assessment parameters – sterility or microbiological purity, approaches to the selection and justification of acceptable levels of microbial contamination.

     • Approaches to the validation of test methods and alternative control methods.