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MT-Messtechnik Hydroflex Pfennig Reinigungstechnik GmbH Vaisala



  • Date:
  • ‌
  • Seminar

Aseptic preparation processes of non-toxic parenteral products in pharmacy and manufacturing facilities

Event location:
Elmshorn
Organizer:
Berner International GmbH

Content: The theoretical part covers the following aspects: Legal foundations: ApBetrO, PIC-Guide, TRGS 525, GMP guidelines, ADKA guideline, BAK guideline GMP-compliant pharmaceutical production: A practical report Entry procedures: materials, personnel, sluice concepts Microbiological validation: validation procedures, nutrient medium filling, sterility testing, environmental monitoring, documentation Microbiological monitoring: particle and airborne microbial measurements, contact plate sampling, sample evaluation: requirements such as incubation time, various nutrient media, documentation of results: handling deviations, setting warning and action limits) + documentation of the results Safety cabinets: function, differences, classification, filters, filter changes, recirculation and exhaust air procedures, etc. Demo: visualization using smoke tests in a safety cabinet: product protection, contamination prevention Working methods for isolators vs. safety cabinets Pharmaceutical aspects: drug effects, aseptic preparation of parenterals, etc. During the internship, the following topics are covered in groups at various workstations: Aseptic preparation: practical work according to GMP guidelines - how does it work? Including behavior in cleanrooms and at safety cabinets, influence of rapid movements, ... Microbiological monitoring: contact plate sampling, active air microbial collection, critical points, correct procedures, etc. Cleaning and disinfection: VAH list, hygiene plan, documentation, differences in the mode of action and application of disinfectants: bactericidal/sporicidal agents, spray vs. wipe disinfection, practical tips Practice clothing concepts, sterile dressing procedures, hand disinfection, proper behavior in the cleanroom Target group: pharmacists, doctors, pharmacy technicians, medical technical assistants, safety officers, nursing staff, technical personnel, monitoring personnel, laboratory planners, laboratory managers



berner_logo_grey_rgb_v1_afb94a2c-1056-4efb-ae65-843e8c0b038c
Berner International GmbH
Werner-von-Siemens-Straße 19
25337 Elmshorn
Germany
Phone: +49 4121 43560
Fax: +49 4121 435620
email: info@berner-safety.de
Internet: https://www.berner-safety.de

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