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Piepenbrock Vaisala Berner International GmbH Systec & Solutions GmbH



  • Date:
  • ‌
  • Seminar

Aseptic preparation processes of non-toxic parenteral drugs in pharmacy and manufacturing operations

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 Guidelines, BAK Guidelines GMP-compliant Pharmaceutical Production: A Practical Report Entry Procedures: Materials, Personnel, Entry Chamber Concepts Microbiological Validation: Validation Procedures, Nutrient Media Filling, Sterility Testing, Environmental Monitoring, Documentation Microbiological Monitoring: Particulate and Air Microbe Measurements, Swab Samples, Sample Evaluation: Requirements such as Incubation Duration, Different Nutrient Media, Documentation of Results: Handling Deviations, Establishing Warning and Action Limits) + Documentation of the Results Safety Cabinets: Function, Differences, Classification, Filters, Filter Replacement, Exhaust and Recirculation Air Procedures, etc. Demo: Visualization using Smoke Tests in a Safety Cabinet: Product Protection, Contamination Prevention Working Methods Isolators vs. Safety Cabinets Pharmaceutical Aspects: Drug Effects, Aseptic Preparation of Parenterals, etc. During the practical training, the following topics are covered in groups at various workstations: Aseptic Preparation: Practical Work according to GMP Guidelines - How is that done? Including Behavior in Clean Rooms and Safety Cabinets, Influence of Rapid Movements, ... Microbiological Monitoring: Swab Samples, Active Air Microbe 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 Processes, Hand Disinfection, Proper Behavior in Clean Rooms Participant Group: Pharmacists, Doctors, PTAs, MTAs, Safety Officers, Nursing Staff, Technical Personnel, Monitoring Staff, 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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